[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"newly-diagnosed-multiple-myeloma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:newly-diagnosed-multiple-myeloma":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,9,0,[8,42,74,100,131,160,182,206,230],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100482153","phase-3-ndmm-patients-candidates-for-asct-comparing-extended-vrd-plus-vs-isa-vrd-vs-isa-v-iberdomide-100482153",false,"NCT05558319","NDMM Patients Candidates for ASCT Comparing Extended VRD Plus vs. Isa-VRD vs. Isa-V-Iberdomide","GEM21menos65. A Phase III Trial for NDMM Patients Who Are Candidates for ASCT Comparing Extended VRD Plus Early Rescue Intervention vs Isatuximab-VRD vs Isatuximab-V-Iberdomide-D","GEM21menos65","Inclusion Criteria:\n\n1. Patient is, in the investigator's opinion, willing and able to comply with the protocol requirements.\n2. Patient must be able to understand the study procedures.\n3. Patient has given voluntary written informed consent before performance of any studyrelated procedure non part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care.\n4. Newly diagnosed multiple myeloma patient who requires start active treatment according to the 2014 IMWG criteria, namely clonal bone marrow plasma cells ≥10% or biopsy-proven bony or extramedullary plasmacytoma and any one or more of the following myeloma defining events: evidence of end organ damage that can be attributed to the underlying plasma cell proliferative disorder, specifically: Hypercalcaemia, Anaemia, Renal Insufficiency, or Bone lesions (one or more osteolytic lesions on skeletal radiography, CT, or PET-CT), and any one or more of the following biomarkers: clonal BMPC% ≥60%, i\u002Fu free light ratio ≥100 or \\> 1 focal lesions on MRI or PET\u002FCT) \\[Lancet Oncol. 2014;15(12): e538-e548\\].\n5. Patient must have a measurable secretory disease defined as either serum monoclonal protein of ≥ 0,5 g\u002Fdl or urine monoclonal (light chain) protein ≥ 200 mg\u002F24 h. For patients whose disease is only measurable by serum FLC, the involved FLC should be ≥ 10mg\u002FdL (100 mg\u002FL), with an abnormal serum FLC ratio.\n6. Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.\n7. Patient must be ≤ 65 years of age.\n8. Patient must have adequate organ function, defined as follows:\n\n   * Absolute neutrophil count (ANC) ≥1.0 X 109\u002FL without G-CSF use in the prior 7 days\n   * Hemoglobin ≥8.0 g\u002FdL (prior red blood cell (RBC) transfusion or recombinant human erythropoietin use is permitted)\n   * Platelets ≥ 75 x 109\u002FL in participants in whom \\\u003C50% of bone marrow nucleated cells are plasma cells and ≥ 50×109\u002FL in participants in whom ≥50% of bone marrow nucleated cells are plasma cells (without transfusion support or thrombopoietin receptor agonist within 7 days before the laboratory test).\n   * Calcium Corrected serum calcium ≤13.5 mg\u002FdL (≤3.4 mmol\u002FL); or free ionized calcium ≤6.5 mg\u002FdL (≤1.6 mmol\u002FL).\n   * Total bilirubin ≤2 X ULN\n   * ALT ≤2.5 X ULN\n   * AST ≤2.5 X ULN\n   * Renal: eGFRa: ≥40 mL\u002Fmin\u002F 1.73 m2\n   * Cardiac: LVEF (echo) ≥ 50%\n9. Female patient: contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. A female patient is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:\n\n   * Is not a woman of childbearing potential (WOCBP), i.e., fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy OR\n   * Is a WOCBP and\n\n     * She understands the potential teratogenic risk to the unborn child\n     * She understands the need for effective contraception as stated in the protocol, without interruption, 28 days before starting study treatment, throughout the entire duration of study treatment, during dose interruptions and for at least 28 days after the last dose of study treatment.\n     * She understands and agrees to inform the Investigator if a change or stop of method of contraception is needed.\n     * She must be capable of complying with effective contraceptive measures.\n     * She is informed and understands the potential consequences of pregnancy and the need to notify her study doctor immediately if there is a risk of pregnancy.\n     * She understands the need to commence study treatment as soon as it is dispensed following a negative pregnancy test.\n     * She understands and accepts the need to undergo pregnancy testing based on the frequency outlined in this plan and in the Informed Consent.\n     * She acknowledges she understands the hazards iberdomide or lenalidomide can cause to an unborn fetus and the necessary precautions associated with the use of study drugs.\n\n   The Investigator must ensure that a WOCBP: i) Complies with the conditions of the pregnancy prevention plan, including confirmation that she has an adequate level of understanding. ii) Acknowledges the aforementioned requirements.\n\n   A WOCBP must have a negative highly sensitive serum pregnancy test (as required by local regulations) within 72 hours before the first dose of study drug.\n\n   Nonchildbearing potential is defined as follows (by other than medical reasons):\n   * Has not achieved menarche at some point.\n   * Has undergone a hysterectomy or bilateral oophorectomy.\n   * Has been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (ie, has had menses at any time in the preceding 24 consecutive months).\n10. Male patient: contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.\n\n    Male patient is eligible to participate if he agrees to the following from the time of first dose of study until 6 months after the last dose of iberdomide or lenalidomide to allow for clearance of any altered sperm:\n    * Understand the potential teratogenic risk if engaged in sexual activity with a pregnant female or a WOCBP.\n    * Understand the need for the use of a condom even if he has had a vasectomy, if engaged in sexual activity with a pregnant female or a FCBP\n    * Understand the potential teratogenic risk, so the subject should not donate semen or sperm.. Understand that the effects on fertility are currently unknown, therefore all family planning options and\u002For alternatives should be thoroughly discussed with the study doctor prior to receiving iberdomide.\n11. All prior treatment-related toxicities (defined by National Cancer Institute- Common Toxicity Criteria for Adverse Events (NCI-CTCAE), version 5.0 must be ≤ Grade 1 at the time of enrolment except for alopecia.\n\nExclusion Criteria:\n\n1. Patient has a diagnosis of primary amyloidosis, monoclonal gammopathy of undetermined significance (MGUS), smoldering multiple myeloma (SMM), plasma cell leukemia or active POEMS syndrome at the time of screening.\n2. Patient has had clinical evidence of central nervous system (CNS) or pulmonary leukostasis, disseminated intravascular coagulation, or CNS multiple myeloma.\n3. Prior history of malignancies, other than multiple myeloma (except for basal or squamous cell carcinoma of the skin, carcinoma in situ of the cervix or the breast), unless the patient has been free of the disease for ≥ 5 years.\n4. Any serious medical condition that places the subject at an unacceptable risk if he or she participates in this study; subjects with conditions requiring chronic steroid or immunosuppressive treatment, such as rheumatoid arthritis, multiple sclerosis and\u002For lupus, that likely need additional steroid or immunosuppressive treatments in addition to the study treatment.\n5. Pregnant or breastfeeding females.\n6. Men and women of reproductive potential who are not using effective contraceptive methods (double barrier method, intrauterine device, oral contraception).\n7. Patient is simultaneously enrolled in other interventional clinical trial.\n8. Patient has used an investigational drug within 28 days or five half-lives, whichever is longer, preceding the first dose of study drug.\n9. Patient must not have received prior radiotherapy (except localized palliative radiotherapy for pain, palliation or fracture) within 2 weeks of start of study therapy. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis.\n10. Major surgery (except kyphoplasty) ≤ 4 weeks prior to initiating protocol therapy.\n11. Patient has peripheral neuropathy or neuropathic pain grade 1 with pain or ≥2, as defined by the National Cancer Institute Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0.\n12. Patient evidence of cardiovascular risk including any of the following:\n\n    * Myocardial infarction within 6 months before randomization, or an unstable or uncontrolled disease\u002Fcondition related to or affecting cardiac function (eg, unstable angina, congestive heart failure, New York Heart Association Class III-IV).\n    * Uncontrolled cardiac arrhythmia.\n    * Screening 12-lead ECG showing a baseline interval QTcF\\> 470 msec (exception: subjects with pacemaker).\n    * Patients with uncontrolled hypertension.\n13. Patients who have current unstable liver or biliary disease defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice, or cirrhosis. Note: Stable chronic liver disease (including Gilbert's syndrome or asymptomatic gallstones) or hepatobiliary involvement of malignancy is acceptable if otherwise meets entry criteria.\n14. Presence of active renal condition (infection, requirement for dialysis or any other condition that could affect patient's safety). Participants with isolated proteinuria resulting from MM are eligible, provided they fulfil inclusion criteria.\n15. Evidence of active mucosal or internal bleeding.\n16. Any serious medical condition or psychiatric illness that would interfere in understanding of the informed consent form.\n17. Uncontrolled endocrine diseases (i.e. diabetes mellitus, hypothyroidism or hyperthyroidism) (i.e. requiring relevant changes in medication within the last month, or hospital admission within the last 3 months).\n18. Patient with acute diffuse infiltrative pulmonary disease and\u002For pericardial disease.\n19. Patient with severe chronic obstructive pulmonary disease (COPD) or asthma with forced expiratory volume in the first minute (FEV1) less than 50%.\n20. History of interstitial lung disease or ongoing interstitial lung disease.\n21. Subject has gastrointestinal disease that may significantly alter the absorption of iberdomide and\u002For other oral study treatment.\n22. Patient has an active infection requiring systemic antibiotic, antiviral, or antifungal treatment at the time of starting treatment.\n23. Patient has known HIV infection.\n24. Patient has positive hepatitis B surface antigen (HBsAg), or hepatitis B core antibody (HBcAb) at screening or within 3 months prior to first dose of study treatment.\n25. Patient has positive hepatitis C antibody test result or positive hepatitis C RNA test result at screening or within 3 months prior to first dose of study treatment. Note: Participants with positive Hepatitis C antibody due to prior resolved disease can be enrolled, only if a confirmatory negative Hepatitis C RNA test is obtained. Note: Hepatitis RNA testing is optional and participants with negative Hepatitis C antibody test are not required.\n26. Patient require concurrent administration of a strong inhibitor or inducer of cytochrome P450 (CYP3A4\u002F5) (including within 14 days of initiating study treatment).\n27. Patient has a known immediate or delayed hypersensitivity reaction or idiosyncratic reactions to iberdomide or drugs chemically related to iberdomide.\n28. Patient has a known immediate or delayed hypersensitivity reaction or idiosyncratic reactions to isatuximab or drugs chemically related to isatuximab, hypersensitivity reactions, or idiosyncratic reactions to other molecular antibodies.\n29. Patient has a known immediate or delayed hypersensitivity reaction or idiosyncratic reactions to lenalidomide or dexamethasone or drugs chemically related to lenalidomide or dexamethasone.","ALL","18 Years","65 Years",{"count":21,"type":22},480,"ESTIMATED","INTERVENTIONAL",[25],"PHASE3","This is a Phase III open-label, 3-arm, parallel, randomized, controlled trial. The allocation ratio 1:1:1 and outcome assessment are blind to group allocation. Patients will be randomized from 3 arms. Patients will receive VRD extended + ASCT plus ERI or Isatuximab-VRD + ASCT or Isatuximab-VID + ASCT.",[28],"Newly Diagnosed Multiple Myeloma","RECRUITING","2026-06-23",{"date":32,"type":33},"2026-06-25","ACTUAL",{"date":35,"type":33},"2022-11-10",{"date":37,"type":22},"2029-04",{"name":39,"class":40},"PETHEMA Foundation","OTHER",68,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":23,"phases":52,"briefSummary":54,"conditions":55,"keywords":59,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":73},"100611939","phase-2-eldorado-elranatamab-versus-daratumumab-in-combination-with-rvd-lite-for-newly-diagnosed-transplant-ineligibledeferred-multiple-myeloma-100611939","NCT07247097","ELDORADO: Elranatamab Versus Daratumumab in Combination With RVd Lite for Newly Diagnosed Transplant Ineligible\u002FDeferred Multiple Myeloma","ELDORADO: a Randomized Phase II Trial of Elranatamab or Daratumumab in Combination With Lenalidomide, Bortezomib, and Dexamethasone (RVd Lite) in Newly Diagnosed, Transplant Ineligible\u002FDeferred Multiple Myeloma","ELDORADO","Inclusion Criteria:\n\n* Participants must be at least 18 years of age\n* Newly diagnosed multiple myeloma, with monoclonal plasma cells in the bone marrow ≥10% or a biopsy proven plasmacytoma and either CRAB criteria or biomarker of malignancy\n\n  a. CRAB criteria, one or more of the following: i. Hypercalcemia: serum calcium (\\>1 mg\u002FdL) higher than the upper limit of normal or \\>11 mg\u002FdL ii. Renal insufficiency: creatinine clearance \\\u003C40 mL\u002Fmin (calculated per local practice) or serum creatinine \\>2 mg\u002FdL iii. Anemia: hemoglobin value \\>2 g\u002FdL below the lower limit of normal or hemoglobin \\\u003C10 g\u002FdL iv. Bone lesions: one or more lytic lesions on skeletal radiography, CT, or PET CT b. Biomarker of malignancy (one or more of the following): i. Clonal bone marrow plasma cells ≥60% ii. Involved:uninvolved serum free light chain ratio ≥100 iii. \\>1 focal lesion on magnetic resonance imaging (MRI)\n* Measurable disease as defined by one of the following:\n\n  1. Serum monoclonal protein ≥0.5 g\u002FdL. For IgA monoclonal protein, total IgA \\>500 mg\u002FdL is allowable.\n  2. Urine monoclonal protein ≥200 mg\u002F24 hours\n  3. Involved serum free light chain ≥100 mg\u002FL with abnormal free light chain ratio\n* Not considered eligible for high dose melphalan and autologous stem cell transplant per treating investigator or plan for deferred high dose melphalan and autologous stem transplant\n* ECOG performance status of 0-2\n* ANC ≥1000\u002FμL. G-CSF is not permitted within 14 days of screening.\n* Platelet count ≥75,000\u002FµL. Platelet count ≥50,000\u002FµL is permitted if bone marrow is \\>50% involved. Platelet transfusion and thrombopoietin receptor agonists are not permitted within 7 days of screening.\n* Hemoglobin ≥ 8 g\u002FdL. Red blood cell transfusions are permitted to meet eligibility criteria.\n* Calculated creatinine clearance of ≥ 30 mL\u002Fmin, not requiring dialysis, with calculation per local practice.\n* Serum bilirubin values \\\u003C 1.5 x ULN. Isolated bilirubin x 1.5 x ULN is acceptable if bilirubin is fractionated and direct bilirubin \\\u003C35%. Patients with elevated bilirubin due to Gilbert's syndrome may be permitted with PI approval (e.g. total bilirubin \\\u003C3 mg\u002FdL and normal direct bilirubin); and\n* Serum aspartate transaminase (ALT) and aspartate transaminase (AST) values \\\u003C 2.5 × the upper limit of normal (ULN) of the institutional laboratory reference range.\n* Must be able to comply with thromboembolism prophylaxis with e.g. acetylsalicylic acid (ASA), apixaban, rivaroxaban, lower molecular weight heparin, or equivalent.\n* Females of childbearing potential (FCBP) must:\n\n  1. Have 2 negative pregnancy tests as verified by the Investigator prior to starting study therapy within 10-14 days, with the second test within 24 hours of starting lenalidomide. She must agree to ongoing pregnancy testing during the course of the study, and after end of study treatment. This applies even if the subject practices true abstinence from heterosexual contact.\n  2. Either commit to true abstinence from heterosexual contact (which must be reviewed on a monthly basis and source documented) or agree to use and be able to comply with two reliable forms of contraception as defined by lenalidomide Risk Evaluation and Mitigation Strategy (REMS) program.\n* Male subjects must follow the lenalidomide REMS.\n* Ability and the willingness to undergo repeat bone marrow biopsy assessments.\n* Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* Prior or current systemic therapy for any plasma cell disorder. An exception is emergency use of corticosteroids (equivalent to dexamethasone 40 mg daily for four days). After discussion with the principal investigator. one cycle of standard of care myeloma therapy (without anti-CD38 monoclonal antibody) is permissible to allow for stabilization of disease, during screening\u002Fprior to enrollment.\n* Pregnancy, currently breastfeeding, or planned breastfeeding.\n* Participant plans to father a child while enrolled in the study or within 100 days after last dose of study treatment.\n* Prior history of malignancies, other than MM, unless the patient has completed definitive treatment and has been free of the disease for ≥3 years. Patients who are free of disease \\\u003C3 years may enroll after approval of the PI (e.g. localized breast cancer considered to have very low risk of recurrence). Exceptions include the following (i.e. the following are eligible to participate):\n\n  1. Basal or squamous cell carcinoma of the skin\n  2. Carcinoma in situ of the cervix\n  3. Ductal carcinoma in situ of the breast\n  4. Incidental histologic finding of prostate cancer (T1a or T1b) managed with surveillance\n  5. Other malignancies of clinically localized disease may be permitted to enroll after discussion with the Sponsor-Investigator\n* Patients with plasma cell leukemia at time of screening, POEMS syndrome, or primary AL amyloidosis are excluded from this trial.\n* Seropositive for HIV infection.\n* Hepatitis B viral load positive.\n* Hepatitis C viral load positive.\n* Peripheral neuropathy ≥grade 2.\n* Patient has a history of significant cardiovascular, neurological, endocrine, gastrointestinal, respiratory, or inflammatory illness that could preclude study participation, pose an undue medical hazard, or interfere with the interpretation of the study results, including, but not limited to:\n\n  1. Congestive heart failure (New York Heart Association \\[NYHA\\] Class 3 or 4)\n  2. Unstable angina\n  3. Clinically significant, uncontrolled cardiac arrhythmia such a 2nd degree or 3rd degree atrioventricular block\n  4. Recent (within the preceding 6 months) myocardial infarction or stroke\n  5. Severe non-ischemic cardiomyopathy.\n  6. Uncontrolled hypertension\n  7. Diabetes mellitus with \\>2 episodes of ketoacidosis in the preceding 12 months\n  8. Chronic obstructive pulmonary disease (COPD) requiring \\>2 hospitalizations in the preceding 12 months.\n  9. Acute diffuse infiltrative pulmonary disease.\n  10. Active bacterial, viral, or fungal infection\n  11. Stroke, transient ischemic attack, or seizure within six months of starting treatment.\n* Patient has any other medical, psychiatric, or social condition that would preclude participation in the study, pose an undue medical hazard, interfere with the conduct of the study, or interfere with interpretation of the study results.\n* Major surgery within 4 weeks prior to C1D1. Kyphoplasty or vertebroplasty are not considered major surgery.\n* Received an investigational drug (or vaccine) or used an invasive investigational medical device within four weeks before screening or is currently enrolled in an interventional investigational study.\n* Live or live-attenuated vaccine within 30 days prior to C1D1.",{"count":51,"type":22},160,[53],"PHASE2","This research study is being done to compare the efficacy and safety of the combination of elranatamab, lenalidomide, bortezomib, dexamethasone versus the combination of daratumumab, lenalidomide, bortezomib, dexamethasone for patients with newly diagnosed, transplant ineligible\u002Fdeferred multiple myeloma.",[56,28,57,58],"Multiple Myeloma","Transplant Ineligible","Newly Diagnosed Multiple Myeloma (NDMM)",[60,61,48,62,63],"NDMM","multiple myeloma","RVd lite","transplant ineligible\u002Fdeferred","NOT_YET_RECRUITING","2026-06-22",{"date":30,"type":33},{"date":68,"type":22},"2026-08-01",{"date":70,"type":22},"2035-12-01",{"name":72,"class":40},"Massachusetts General Hospital",3,{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":82,"targetDuration":4,"studyType":23,"phases":84,"briefSummary":86,"conditions":87,"keywords":88,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":99},"100637076","phase-1-phase-1b2-isatuximab-iberdomide-bortezomib-dexamethasone-in-transplant-ineligibledeferred-newly-diagnosed-myeloma-100637076","NCT07601100","Phase 1b\u002F2: Isatuximab, Iberdomide, Bortezomib, Dexamethasone in Transplant Ineligible\u002FDeferred Newly Diagnosed Myeloma","A Phase 1b\u002F2 Study of the Combination Isatuximab, Iberdomide, Bortezomib, and Dexamethasone in Newly Diagnosed Multiple Myeloma Who Are Transplant Ineligible or Not Intended for Upfront Transplant","IsaIberVD","Inclusion Criteria:\n\n* Male or female, 18 years of age or older\n* Ability to understand and the willingness to sign a written informed consent document\n* NDMM based on IMWG criteria with clonal bone marrow plasma cells \\>10% or biopsy proven bony or extramedullary disease\u002Fplasmacytoma (EMD) with any one or more CRAB-features or myeloma defining events (Rajkumar, 2024). (See Appendix G)\n* Ineligible for ASCT as assessed by the treating physician or eligible but prefers and agrees to defer ASCT until after induction and maintenance therapy, upon progression or at a later time\n* Measurable disease defined as at least one of the following:\n\n  * Serum M-protein 0.5 g\u002FdL\n  * Urine M-protein 200 mg\u002F24 hours\n  * Serum FLC assay: involved FLC 10 mg\u002FdL (100 mg\u002FL) and an abnormal kappa to lambda FLC ratio (\\\u003C 0.26 or \\> 1.65)\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (See Appendix A)\n* Screening Laboratory evaluations with the following parameters:\n\n  * Absolute neutrophil count (ANC) ≥ 1,000 cells\u002FdL (1.0 x 109\u002FL)\n\n    \\--- Note: Growth factor support is not permitted within 10 days, \\[14 days for pegfilgrastim\\], prior to the screening hematologic test.\n  * Platelet count ≥ 75,000 cells\u002FdL (75 x 109\u002FL) (without transfusions required during the 3 days prior to the screening hematologic test)\n  * Total Bilirubin ≤ 2 X upper limit of normal (ULN) (except patients with Gilbert Syndrome, who can have total bilirubin \\\u003C 3.0 mg\u002FdL)\n  * AST (SGOT) and ALT (SGPT) ≤ 3.0 x ULN\n  * Calculated creatinine clearance (CrCl) 30ml\u002Fmin (Appendix B)\n  * Hemoglobin ≥ 8.0 g\u002Fdl (red blood cell (RBC) transfusions are permitted)\n* Individuals of childbearing potential (IOCBP) must have 2 negative pregnancy tests before initiation of therapy, and agree to ongoing testing, based on the frequency outlined in the Pregnancy Prevention Plan (PPP) (See Appendix H)\n* Sexually active IOCBP agree to use protocol-specified contraceptive methods, at least 28 days prior to starting study drug, while taking study drug, including interruptions in study drugs, and for at least 28 days after the last dose of study drug or males sexually active with IOCBP, (including those who have had a vasectomy), agree to use protocol specified contraceptive methods while taking study drug, including interruptions in study drug and for at least 28 days after the last dose of iberdomide, 5 months after isatuximab and 6 months after bortezomib, according to the PPP (See Appendix H)\n* All patients (male and female with or without childbearing potential) agree to counseling according to the PPP and to abstain from donating blood products for at least 28 days after the last dose of iberdomide and abstain from donating semen or sperm while taking study drug and for at least 28 days after the last dose of iberdomide according to the PPP (See Appendix H) and for 5 months after the last dose of isatuximab and 6 months after the last dose of bortezomib\n* Must be able to take antithrombotic prophylaxis (See Section 5.9.1)\n\nExclusion Criteria:\n\n* Prior therapy for MM. Patients may have received:\n\n  * Corticosteroids for management of MM not to exceed equivalent of 160 mg of dexamethasone in a 2-week period and should be stable 7 days prior to the registration.\n  * Focal palliative radiation for the management of bone pain completed ≥ 7 days prior to registration\n  * Treatment for smoldering myeloma as long as the prior treatment did not include anti-CD38 therapy:\n\n    * Patients with a prior history of serious allergic reactions associated with thalidomide, lenalidomide, or pomalidomide should not receive iberdomide as they could be at higher risk of hypersensitivity.\n    * Resolution of symptoms of prior treatment to ≤ grade 1 or baseline\n* Known intolerance to steroid therapy\n* Prior history of malignancies, other than MM, will be excluded unless the participant has been free of the disease for ≥ 3 years with the exception of the following non-invasive malignancies: basal or squamous cell skin carcinoma, carcinoma in situ of the cervix, carcinoma in situ of the breast, incidental histological findings of prostate cancer (T1a or T1b using the Tumor, Node, Metastasis (TNM) clinical staging system), or prostate cancer that is curative\n* Central nervous system involvement with MM\n* Peripheral neuropathy grade 3, or grade 2 with pain on clinical exam during screening period\n* Any medical or psychiatric illness that in the investigator's opinion would impose excessive risk to the patient or would adversely affect participation\n* Concurrent uncontrolled cardiovascular conditions (uncontrolled hypertension, uncontrolled arrhythmias, congestive heart failure, unstable angina, grade 3 thromboembolic event or myocardial infarction) in the past 6 months\n* Concurrent symptomatic amyloidosis or plasma cell leukemia\n* POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein and skin changes)\n* Seropositive for human immunodeficiency virus (HIV-1), chronic or active hepatitis B (defined as positive hepatitis B surface antigen (HepBSAg) or Hepatitis B core antibody (HepBcore Ab) or C (Hep C Ab), or acute hepatitis A. If any history of exposure to hepatitis B or C, then PCR should be negative\n* Pregnant or breast feeding female or IOCBP who intend to become pregnant during the study.\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to other agents used in study",{"count":83,"type":22},88,[85,53],"PHASE1","This study is to evaluate the combination of isatuximab, iberdomide, bortezomib, and dexamethasone in newly diagnosed multiple myeloma participants who are transplant ineligible or not intended for upfront transplant.\n\nThe names of the study drugs used in this research study are:\n\nisatuximab, iberdomide, bortezomib dexamethasone",[28],[61,89],"newly diagnosed multiple myeloma","2026-05-28",{"date":92,"type":33},"2026-06-01",{"date":94,"type":22},"2026-06-26",{"date":96,"type":22},"2034-07-01",{"name":98,"class":40},"Dana-Farber Cancer Institute",2,{"id":101,"slug":102,"hasResults":11,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":106,"eligibilityCriteria":107,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":108,"targetDuration":4,"studyType":23,"phases":110,"briefSummary":111,"conditions":112,"keywords":113,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":130},"100568275","phase-3-a-study-of-belantamab-mafodotin-administered-in-combination-with-lenalidomide-and-dexamethasone-brd-versus-daratumumab-lenalidomide-and-dexamethasone-drd-in-participants-with-newly-diagnosed-multiple-myeloma-ndmm-who-are-ineligible-for-autologous-stem-cell-transplantation-ti-ndmm-100568275","NCT06679101","A Study of Belantamab Mafodotin Administered in Combination With Lenalidomide and Dexamethasone (BRd) Versus Daratumumab, Lenalidomide, and Dexamethasone (DRd) in Participants With Newly Diagnosed Multiple Myeloma (NDMM) Who Are Ineligible for Autologous Stem Cell Transplantation (TI-NDMM)","A Phase 3, Randomized, Open-label Study of Belantamab Mafodotin Administered in Combination With Lenalidomide and Dexamethasone (BRd) Versus Daratumumab, Lenalidomide, and Dexamethasone (DRd) in Participants With Newly Diagnosed Multiple Myeloma Who Are Ineligible for Autologous Stem Cell Transplantation (TI-NDMM)","DREAMM-10","Inclusion Criteria:\n\n1. Is at least 18 or the legal age of consent in the jurisdiction in which the study is taking place, at the time of signing the informed consent.\n2. Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form and in the protocol.\n3. NDMM with a requirement for treatment as documented per IMWG criteria.\n4. Must have at least 1 aspect of measurable disease, as assessed by the central laboratory, defined as 1 of the following:\n\n   1. Urine M-protein excretion ≥200 mg\u002F24 hours (≥0.2 g\u002F24 hours) And\u002For\n   2. Serum M-protein concentration ≥0.5 g\u002FdL (≥5.0 g\u002FL) And\u002For\n   3. Serum free light-chain (FLC) assay: involved FLC level ≥10 mg\u002FdL (≥100 mg\u002FL) and an abnormal serum FLC ratio (\\\u003C0.26 or \\>1.65).\n5. Newly diagnosed and not considered candidate for high-dose chemotherapy with autologous stem cell transplant (ASCT) due to any of the following:\n\n   1. Exclusion from treatment with ASCT due to country- or site-specific age restriction.\n   2. Presence of comorbid condition(s) likely to have a negative impact on tolerability of high-dose chemotherapy with ASCT.\n6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.\n7. Adequate organ system function as defined by the laboratory assessments.\n8. Male participants:\n\n   * Contraceptive use by men should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.\n   * Male participants are eligible to participate if they agree to the following during the Treatment Period and for at least 6 months after the last dose of study intervention to allow for clearance of any altered sperm:\n   * Refrain from donating fresh unwashed semen\n\n   PLUS either:\n   * Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent.\n\n   OR\n   * Must agree to use contraception\u002Fbarrier as detailed below\n   * Agree to use a male condom, even if they have undergone a successful vasectomy, and female partner to use an additional highly effective contraceptive method with a failure rate of \\\u003C1% per year when having sexual intercourse with a woman of childbearing potential (WOCBP) who is not currently pregnant. Male participants should also use a condom when having sexual intercourse with pregnant females.\n9. Female participants\n\n   * Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.\n   * A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least 1 of the following conditions applies:\n   * Is not a WOCBP OR\n   * Is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of \\\u003C1% per year), preferably with low user dependency during the Treatment Period and for 4 months after the last dose of study intervention and agrees not to donate eggs (ova, oocytes) for the purpose of reproduction during this period. The investigator should evaluate the effectiveness of the contraceptive method in relationship to the first dose of study intervention.\n   * A WOCBP must have 2 negative highly sensitive serum pregnancy tests before starting treatment, the first may be performed within 14 days from C1D1, the second within 24 hours before the first dose of study intervention.\n   * Should pregnancy occur in a female on treatment or the female partner of a male on treatment, treatment must be stopped, and it is advised to seek advice from a physician specialized or experienced in teratology.\n\nExclusion Criteria:\n\n1. Diagnosis of systemic amyloid light chain amyloidosis, Waldenstrom's disease, POEMS (polyneuropathy, organomegaly, endocrinopathy, monoclonal plasma proliferative disorder, skin changes) or Primary Plasma Cell Leukemia (defined as circulating plasma cells \\>5%).\n2. Prior systemic therapy for multiple myeloma, or smoldering multiple myeloma.\n3. Signs of meningeal or central nervous system involvement with multiple myeloma.\n4. Major surgery within 2 weeks prior to the first dose of study drugs or has not recovered fully from surgery. Kyphoplasty is not considered major surgery.\n5. Any serious and\u002For unstable pre-existing medical, psychiatric disorder or other conditions (including lab abnormalities) that could interfere with participant's safety, obtaining informed consent, or compliance with study procedures.\n6. Current active liver or biliary disease (except for Gilbert's syndrome or asymptomatic gallstones, or otherwise stable chronic liver disease as per the investigator's assessment).\n7. Participants with previous or concurrent malignancies other than multiple myeloma are excluded. Exceptions are any other malignancy that has been considered medically stable for at least 2 years, after discussion with the GSK Medical Monitor. The participant must not be receiving active therapy, other than hormonal therapy for this disease.\n8. Evidence of cardiovascular risk including any of the following:\n\n   1. Evidence of current clinically significant untreated arrhythmias, including clinically significant electrocardiogram abnormalities including second-degree (Mobitz Type II) or third-degree atrioventricular block.\n   2. Recent history (within 3 months of screening) of myocardial infarction, acute coronary syndromes (including unstable angina), coronary angioplasty or stenting, or bypass grafting.\n   3. Class III or IV heart failure as defined by the New York Heart Association functional classification system.\n9. Known human immunodeficiency virus (HIV) infection, unless the participant can meet all of the following criteria:\n\n   1. Established antiretroviral therapy for at least 4 weeks and HIV viral load \\\u003C400 copies\u002FmL within Screening Period.\n   2. CD4+ T-cell (CD4+) counts ≥350 cells\u002FμL.\n   3. No history of acquired immune deficiency syndrome-defining opportunistic infections within the last 12 months.\n10. Positive hepatitis C antibody test result or positive hepatitis C ribonucleic acid (RNA) test result at screening or within 3 months prior to first dose of study intervention unless the participant can meet the following criteria:\n\n    1. RNA test negative.\n    2. Successful antiviral treatment (usually 8 weeks duration) is required, followed by a negative hepatitis C viral load RNA test after a washout period of at least 4 weeks.\n11. Participants with hepatitis B will be excluded unless the defined criteria can be met.\n12. Current corneal epithelial disease except for mild punctate keratopathy.\n13. Intolerance or contraindications to antiviral prophylaxis.\n14. Unable to tolerate antithrombotic prophylaxis.\n15. Known immediate or delayed hypersensitivity reaction or idiosyncratic reaction to drugs chemically related to belantamab mafodotin, or any of the components of the study intervention.\n16. Plasmapheresis within 7 days prior to the first dose of study intervention.\n17. Participants must not have received a live or live-attenuated vaccine within 30 days prior to first dose of belantamab mafodotin.",{"count":109,"type":22},520,[25],"The purpose of this Phase 3 study is to evaluate if BRd prolongs progression free survival (PFS) and\u002For improves minimal residual disease (MRD) negative status compared with DRd in participants with TI-NDMM.",[56,28],[114,115,116,117,118,119,106],"Multiple myeloma","Belantamab mafodotin","Lenalidomide","Dexamethasone","Daratumumab","Transplant-ineligible","2026-04-17",{"date":122,"type":33},"2026-04-22",{"date":124,"type":33},"2024-12-16",{"date":126,"type":22},"2031-04-28",{"name":128,"class":129},"GlaxoSmithKline","INDUSTRY",181,{"id":132,"slug":133,"hasResults":11,"nctId":134,"briefTitle":135,"officialTitle":136,"acronym":137,"eligibilityCriteria":138,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":139,"targetDuration":4,"studyType":23,"phases":141,"briefSummary":143,"conditions":144,"keywords":147,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":151,"lastUpdatePostDateStruct":152,"startDateStruct":154,"completionDateStruct":156,"leadSponsor":158,"locationsCount":99},"100459202","biomarkers-in-multiple-myeloma-100459202","NCT05259553","Biomarkers in Multiple Myeloma","Evaluation of Predictive Biomarkers in de Novo Multiple Myeloma on the Onset of Venous Thromboembolism, Its Impact on Clinical Outcome and Thromboprophylaxis (VESICOM)","VESICOM","Inclusion Criteria:\n\n* Patient affiliated to a social security regimen or beneficiary of the same\n* Signed written informed consent form\n* Confirmed diagnosis of de novo multiple myeloma, non-previously treated and requiring treatment.\n\nExclusion Criteria:\n\n* Pregnant women\n* Patient under guardianship or deprived of his liberty or any condition that may affect the patient's ability to understand and sign the informed consent\n* Refusing participation\n* Patient whose follow-up or life expectancy is less than 6 months.",{"count":140,"type":22},70,[142],"NA","The association between multiple myeloma (MM) and venous thromboembolism (VTE) is well known. Indeed, the incidence of VTE is increased in patients with newly diagnosed MM and in patients treated by immunomodulatory drugs in combination with glucocorticoids. Moreover, the clinical outcome of MM is supposed to be correlated to the risk of thrombosis. At the biological level, a number of hemostasis abnormalities participate in increasing VTE incidence. Yet, data on predictive biomarkers linked to VTE are limited.",[145,28,146],"Hematological Patients","Chemotherapy",[148,61,149,150],"hematology","chemotherapy","thromboprophylaxis","2025-04-07",{"date":153,"type":33},"2025-04-09",{"date":155,"type":33},"2022-05-20",{"date":157,"type":22},"2027-10-30",{"name":159,"class":40},"Centre Hospitalier Universitaire de Saint Etienne",{"id":161,"slug":162,"hasResults":11,"nctId":163,"briefTitle":164,"officialTitle":165,"acronym":4,"eligibilityCriteria":166,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":167,"targetDuration":4,"studyType":23,"phases":169,"briefSummary":170,"conditions":171,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":172,"lastUpdatePostDateStruct":173,"startDateStruct":175,"completionDateStruct":177,"leadSponsor":179,"locationsCount":181},"100584911","phase-3-a-study-to-evaluate-the-efficacy-and-safety-of-hlx15-iv-versus-darzalex-in-combination-with-lenalidomide-dexamethasone-rd-in-transplant-ineligible-patients-with-newly-diagnosed-multiple-myeloma-100584911","NCT06895512","A Study to Evaluate the Efficacy and Safety of HLX15-IV Versus DARZALEX® in Combination with Lenalidomide-Dexamethasone (Rd) in Transplant-ineligible Patients with Newly Diagnosed Multiple Myeloma","A Randomized, Double-blind, Parallel-controlled, Multicenter, Phase III Study to Evaluate the Efficacy and Safety of HLX15-IV Versus DARZALEX® in Combination with Lenalidomide-Dexamethasone (Rd) in Transplant-ineligible Patients with Newly Diagnosed Multiple Myeloma","Inclusion Criteria:\n\n1. Capable to understand and sign the ICF.\n2. Patients aged ≥ 18 years .\n3. Patient must have documented multiple myeloma (MM) satisfying the International Myeloma Working Group (IMWG) diagnostic criteria for MM.\n4. Newly diagnosed, untreated and not considered candidate for autologous stem cell transplantation (ASCT).\n5. Patient must have an ECOG performance status score of 0.\n6. Patient must have pretreatment clinical laboratory values.\n7. Contraceptive use by men or women should be consistent with local regulations.\n8. A WOCBP must have a negative serum pregnancy test at screening within 72 hours prior to randomization.\n\nExclusion Criteria:\n\n1. Patient has a diagnosis of primary amyloidosis, monoclonal gammopathy of undetermined significance (MGUS), smoldering multiple myeloma (SMM), Waldenström's disease, or other conditions in which IgM M-protein is present in the absence of a clonal plasma cell infiltration with lytic bone lesions.\n2. Patient has plasma cell leukemia or POEMS syndrome .\n3. Patient has prior or current systemic therapy or ASCT for MM before randomization.\n4. Patient has peripheral neuropathy or neuropathic pain Grade 2 or higher.\n5. Patient has a history of malignancy (other than MM) within 3 years before randomization .\n6. Patient has clinical signs of meningeal involvement of MM.\n7. Patient has known COPD, persistent asthma, or a history of asthma within the last 2 years.\n8. Patient is known to be seropositive for history of human immunodeficiency virus (HIV) or known to have treponema pallidum antibodies (Anti-TP).\n9. Patient is known to have active hepatitis B or C.\n10. Patient has any concurrent medical or psychiatric condition or disease that is likely to interfere with the study procedures or results.\n11. Patient has clinically significant cardiac disease.\n12. Patient has known allergies, hypersensitivity, or intolerance to treatment drugs.\n13. Patient has history of drug abuse or substance abuse.\n14. Patient is a woman who is pregnant, or breast-feeding, or planning to become pregnant or donate eggs (ova, oocytes).\n15. Patient had radiation therapy within 14 days of randomization.\n16. Patient had plasmapheresis within 28 days of randomization.\n17. Patient had major surgery within 28 days before randomization.\n18. Patient in clinical trials of any other drug or device within 3 months before randomization.\n19. Patient has any condition could prevent, limit, or confound the protocol-specified assessments.",{"count":168,"type":22},386,[25],"This is a randomized, double-blind, parallel-controlled, multicenter, phase III study to compare the efficacy and safety of HLX15-IV in combination with Rd (HLX15-IV-Rd) versus DARZALEX® in combination with Rd (D-Rd) in patients with NDMM who are ineligible for autologous stem cell transplantation (ASCT).",[28],"2025-03-19",{"date":174,"type":33},"2025-03-26",{"date":176,"type":22},"2025-04",{"date":178,"type":22},"2027-07",{"name":180,"class":129},"Shanghai Henlius Biotech",1,{"id":183,"slug":184,"hasResults":11,"nctId":185,"briefTitle":186,"officialTitle":187,"acronym":4,"eligibilityCriteria":188,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":189,"targetDuration":4,"studyType":23,"phases":191,"briefSummary":192,"conditions":193,"keywords":194,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":197,"lastUpdatePostDateStruct":198,"startDateStruct":200,"completionDateStruct":202,"leadSponsor":204,"locationsCount":73},"100577544","phase-1-a-phase-ibii-clinical-study-on-the-application-of-linperlisib-combined-with-the-vrd-regimen-in-newly-diagnosed-patients-with-multiple-myeloma-100577544","NCT06799676","A Phase Ib\u002FII Clinical Study on the Application of Linperlisib Combined with the VRD Regimen in Newly Diagnosed Patients with Multiple Myeloma","A Single-Arm, Multicenter, Open-Label Phase Ib\u002FII Clinical Study on the Application of Linperlisib Plus the VRD Regimen in Newly Diagnosed Patients with Multiple Myeloma","Inclusion Criteria:\n\n* 1.Patients must be newly diagnosed with active multiple myeloma. 2. Patients must be between 18 and 65 years old and eligible for autologous hematopoietic stem cell transplantation (ASCT).\n\n  3\\. Patients must have measurable disease, defined as follows:\n* Any quantifiable serum monoclonal protein level (typically but not necessarily ≥0.5 g\u002FdL of M-protein), and\u002For urinary light chain excretion \\>200 mg\u002F24 hours.\n* For oligosecretory or non-secretory multiple myeloma (MM), patients must have measurable plasmacytomas \\>2 cm confirmed by clinical examination or imaging (e.g., MRI, CT scan) or an abnormal free light chain (FLC) ratio (normal value: 0.26-1.65) with an involved FLC level ≥10 mg\u002FdL.\n\n  4\\. Patients must have an expected survival of ≥3 months. 5. Karnofsky Performance Status (KPS) score must be ≥60%. 6. Liver Function:\n* Serum alanine aminotransferase (ALT) ≤3 times the upper limit of normal (ULN).\n* Aspartate aminotransferase (AST) ≤3 times ULN.\n* Direct bilirubin ≤2 mg\u002FdL (34 µmol\u002FL) within 14 days prior to randomization. 7. Neutrophil and Platelet Counts: Absolute neutrophil count (ANC) ≥1.0 × 10⁹\u002FL within 14 days prior to randomization.Platelet count ≥75 × 10⁹\u002FL (or ≥50 × 10⁹\u002FL if \\>50% of bone marrow is involved with myeloma) within 14 days prior to randomization.\n\n  8\\. Creatinine clearance (CrCl) ≥30 mL\u002Fmin, measured or calculated using standard formulas (e.g., Cockcroft-Gault) within 7 days prior to randomization.\n\n  9\\. Corrected serum calcium levels must be ≤14 mg\u002FdL (3.5 mmol\u002FL). 10. Left ventricular ejection fraction (LVEF) must be ≥40%. Two-dimensional transthoracic echocardiography (ECHO) is the preferred method for assessment. If ECHO is unavailable, a multigated acquisition scan (MUGA) is acceptable.\n\n  11\\. Patients must be able to understand and voluntarily sign the informed consent form.\n\n  12\\. Women with childbearing potential must agree to undergo pregnancy testing and use contraception.\n\n  13\\. Male subjects must agree to use contraception.\n\nExclusion Criteria:\n\n* 1\\. Patients who have previously received anti-myeloma therapy, except for radiotherapy, bisphosphonates, or a single short course of steroids (≤40 mg\u002Fday of dexamethasone equivalent for up to 4 days).\n\n  2\\. Non-secretory MM patients, unless they have abnormal serum free light chains or a measurable plasmacytoma with a minimum maximum diameter \\>2 cm.\n\n  3\\. Patients who do not meet the eligibility criteria for autologous stem cell transplantation.\n\n  4\\. Women who are pregnant or breastfeeding. 5. Acute active infections requiring treatment (ongoing use of systemic antibiotics, antiviral, or antifungal agents) within 14 days prior to randomization.\n\n  6\\. Patients with known human immunodeficiency virus (HIV) infection. 7. Active hepatitis A, B, or C infection. 8. Patients with the following cardiac conditions within 4 months prior to randomization:\n* Unstable angina or myocardial infarction.\n* New York Heart Association (NYHA) Class III or IV heart failure.\n* Uncontrolled angina.\n* Severe coronary artery disease.\n* Severe ventricular arrhythmias.\n* Sick sinus syndrome.\n* Acute ischemia.\n* Electrocardiographic evidence of Grade 3 conduction abnormalities, unless the patient has a pacemaker.\n\n  9\\. Severe neuropathy (Grade 3-4 or Grade 2 with pain) as defined by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTC) Version 4.0 within 14 days prior to randomization.\n\n  10\\. Known allergy to any of the investigational drugs. 11. Patients with contraindications to required concomitant medications or supportive therapies, including hypersensitivity to all anticoagulants, antiplatelets, or antiviral agents, or intolerance to hydration due to pre-existing pulmonary or cardiac impairment.\n\n  12\\. Any other clinically significant disease or condition that, in the investigator's opinion, could interfere with protocol adherence or the patient's ability to provide informed consent.",{"count":190,"type":22},42,[85,53],"This study aims to evaluate the safety and efficacy of Linperlisib combined with the VRD regimen in the treatment of newly diagnosed patients with multiple myeloma. The study is divided into a Phase Ib dose exploration phase and a Phase II expansion phase.The Phase Ib dose exploration phase primarily aims to determine the recommended Phase II dose (RP2D) of Linperlisib based on dose-limiting toxicity (DLT). The Phase II expansion phase involves induction therapy using at least four cycles of Linperlisib at RP2D in combination with the VRD regimen. After completing four cycles of induction therapy, patients eligible for autologous hematopoietic stem cell transplantation (ASCT) will undergo the procedure. For patients whose therapeutic evaluation results in PD (progressive disease) or SD (stable disease), alternative treatment regimens will be considered based on their condition. After successful transplantation, 2-4 cycles of the original induction regimen will be used for consolidation therapy.The primary objective is to evaluate the proportion of patients achieving a very good partial response (VGPR) after four cycles of induction therapy with the Linperlisib combined VRD regimen.",[28],[61,195,196],"PI3Kδ inhibitor","Linperlisib","2025-01-27",{"date":199,"type":33},"2025-01-29",{"date":201,"type":22},"2025-02",{"date":203,"type":22},"2027-10",{"name":205,"class":40},"Fuling Zhou",{"id":207,"slug":208,"hasResults":11,"nctId":209,"briefTitle":210,"officialTitle":211,"acronym":212,"eligibilityCriteria":213,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":214,"enrollmentInfo":215,"targetDuration":4,"studyType":23,"phases":217,"briefSummary":218,"conditions":219,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":220,"lastUpdatePostDateStruct":221,"startDateStruct":223,"completionDateStruct":225,"leadSponsor":227,"locationsCount":229},"100490362","phase-2-expression-linked-and-r-iss-adapted-stratification-for-first-line-therapy-in-multiple-myeloma-patients-100490362","NCT05665140","Expression-linked and R-ISS-adapted Stratification for First Line Therapy in Multiple Myeloma Patients","Phase II Trial for Newly Diagnosed Low-risk Multiple Myeloma Patients Comparing 6 Cycles of Isatuximab With Lenalidomide\u002FBortezomib\u002FDexamethasone (I-VRD) Compared to 3 Cycles of I-VRD Followed by One Cycle of High-dose Therapy and Both Arms Followed by Maintenance Therapy With I-R.","ELIAS","Inclusion Criteria:\n\n1. newly diagnosed, untreated, symptomatic, documented myeloma (according to the revised Hypercalcaemia, renal dysfunction, anaemia and bone lesions (CRAB) criteria 2014, see Appendix 1) with clonal bone marrow (BM) plasma cells ≥10% or biopsy-proven osseous or extramedullary plasmacytoma and any one or more of the following myeloma defining events: I. Hypercalcemia: serum calcium \\>0,25 mmol\u002FL (\\>1 mg\u002Fdl) higher than the upper limit of normal or \\>2,75 mmol\u002FL (\\>11 mg\u002FdL) II. Renal insufficiency: serum creatinine \\> 177 μmol\u002Fl (\\>2 mg\u002Fdl) III. Anemia: hemoglobin value of \\>20 g\u002Fl below the lower limit of normal or a hemoglobin value lower than 10g\u002Fdl.\n\n   IV. Bone lesions: one or more osteolytic lesions on skeletal radiography, CT, or PET- CT (positron emission tomography) V. Clonal BM plasma cell percentage ≥60% VI. Involved: uninvolved serum free light chain ratio ≥100 VII. \\>1 focal lesion on MRI examination\n2. Presence of measurable disease:\n\n   I. Serum M-protein ≥ 0.5 g\u002FdL or urine M-protein ≥ 200 mg\u002F24 hours. II. Involved FLC (free light chain) level ≥ 10 mg\u002Fdl, provided sFLC (free light chain) ratio is abnormal.\n3. R-ISS stage I33 (see appendix 2)\n4. Standard gene expression pattern of isolated plasma cell based on SKY92 GEP assay\n5. Must be ≥ 18 and ≤70 years at the time of signing the informed consent form.\n6. Must be able to adhere to the study visit schedule and other protocol requirements in the investigator's opinion.\n7. WHO (see Appendix 3) performance status 0-2 (WHO=2 is allowed only if caused by MM and not by co-morbid conditions).\n8. Ability to understand and willingness to sign written informed consent. Signed informed consent must be obtained before any study specific procedure.\n9. Suitable for high-dose melphalan and stem cell retransfusion.\n10. Subjects must have adequate vascular access for leukapheresis\n\n    .\n11. Male or Female\n\nMale participants:\n\nA male participant must agree to use contraception during the intervention period and for at least 5 months after the last dose of isatuximab treatment and refrain from donating sperm during this period.\n\nFemale participants:\n\nA female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:\n\ni) Not a Female of childbearing potential (FCBP), OR ii) A FCBP who must have a negative serum or urine pregnancy test with a sensitivity of at least 25 milliliter units (mIU)\u002FmL within 28 days prior to and again within 24 hours prior to starting study medication and before each cycle of study treatment as well as day 21 of induction and experimental arm consolidation as well as every 28 days during all other cycles. If heavy menstruation appears or a menstruation is delayed, additional tests have to be performed. Participants must either commit to continue abstinence from heterosexual intercourse or apply a highly effective method of birth control during the intervention period and for at least 5 months after the last dose of isatuximab treatment Of note: contraception duration should take also into consideration any backbone therapy\n\nAll females:\n\nMust understand the damages and hazards lenalidomide can cause to an unborn fetus and the necessary precautions associated with the use of lenalidomide.\n\nFemales of childbearing potential (FCBPs) must understand the need for effective contraception, without interruption. This should be 28 days before starting lenalidomide, isatuximab, throughout the entire duration of study and at least 5 months after the last dose of lenalidomide or isatuximab.\n\nAll female and male patients with fertile partners must adhere to the following recommendations:\n\nI. If the female patients are permanently sterile or post-menopausal, they are considered to have no childbearing potential. Permanent sterilization methods include hysterectomy, bilateral salpingectomy. The postmenopausal state is defined as the absence of menstruation within 12 months without alternative medical reasons.\n\nII. Female patients with fertility (and male patients with fertile partners) must agree to use an effective method of contraception (pearl index \\\u003C1) throughout the study period and for 12 months thereafter.\n\nIII. According to the \"Recommendations Related to Contraception and Pregnancy Tests in Clinical Trials\" (Clinical Trial Facilitation Group, 2014-09-15), birth control methods considered to be very effective include:\n\n* Combined (including estrogen and progesterone) hormonal contraception related to ovulation suppression\\*:\n\n  * oral\n  * In the vagina\n  * Transdermal \\*Due to the increased risk of venous thromboembolism in subjects with multiple myeloma taking lenalidomide and dexamethasone, the use of combined oral contraceptive pills are not recommended and the method should be changed\n* Progesterone-only hormone contraception associated with inhibition of ovulation\\*:\n\n  * oral\n  * Injectable\n  * Implantable\n* Intrauterine device (IUD)\n* Intrauterine Hormone-releasing System (IUS)\n* Vasectomized partner (with confirmed surgical success)\n* Sexual abstinence (when consistent with the subject's usual lifestyle) IV. Investigational medicial product (IMP) may interact with hormonal contraceptives and may reduce the effectiveness of contraceptive methods V. Women using hormonal contraceptives should add a barrier method as a second form of contraception, because it is currently unknown whether lenalidomide, isatuximab, bortezomib or dexamethasone may reduce the effectiveness of hormonal contraceptives.\n\nVI. Breast-feeding lenalidomide and its metabolites are excreted in human milk. It is unknown whether isatuximab is secreted in milk. A risk to the newborns\u002Finfants cannot be excluded. Breast-feeding should be discontinued during treatment with lenalidomide and isatuximab VII. Must adhere to regular pregnancy tests (at least every 21 days during induction and consolidation (experimental arm) and 28 days during maintenance and other therapy cycles, in case of irregular menstruation at least every two weeks, if heavy menstruation appears or menstruation is delayed, additional tests have to be performed).\n\nVIII. Notify investigator if method of contraception is changed. IX. Notify investigator immediately in case of pregnancy\n\nMale subjects must agree:\n\nI. to use a condom during sexual contact with a pregnant female or a FCBP while taking lenalidomide or isatuximab, during any dose interruptions and for 5 months after the last dose of lenalidomide or isatuximab, II. Not donate semen or sperm while receiving lenalidomide, during dose interruptions and for at least 5 months after the last dose of lenalidomide and\u002For isatuximab.\n\nIII. Receive counseling about pregnancy precautions and the potential risks of fetal exposure to lenalidomide at a minimum of every 28 days l) All subjects must: I. Agree to abstain from donating blood while taking lenalidomide, during dose interruptions and for at least 5 months after the last dose of lenalidomide and\u002For Isatuximab.\n\nII. Agree never to give lenalidomide to another person. III. Agree to return all unused lenalidomide capsules to the investigator (with exception of prescribed lenalidomide capsules) IV. Be aware that no more than a 28-day lenalidomide supply may be dispensed with each cycle of lenalidomide during induction and consolidation therapy and be prescribed during maintenance therapy.\n\nExclusion Criteria:\n\n1. Direct Coombs test positive hemolytic anemia.\n2. Involvement of the central nervous system (CNS).\n3. History or presence of clinically relevant CNS pathology such as clinically relevant epilepsy, seizure, paresis, aphasia, stroke, subarachnoid hemorrhage or other CNS bleed, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis.\n4. Subject with active or history of plasma cell leukemia, Waldenström's macroglobulinemia, POEMS syndrome or clinically significant amyloidosis.\n5. Patients having nonsecretory MM.\n6. Systemic AL amyloidosis (with exception of AL amyloidosis of BM).\n7. Previous chemotherapy or radiotherapy during the past 5 years except local radiotherapy in case of local myeloma progression or benign diseases, such as nonmalignant thyroid diseases. (Note: patients may have received a cumulative dose of up to 320 mg of dexamethasone or equivalent as emergency therapy.) Previous therapy due to smouldering myeloma or a single dose of bortezomib may be acceptable. In this case the coordinating investigator or his deputy has to be consulted prior to inclusion.\n8. Patients with any of the following laboratory abnormalities:\n\n   I. Absolute neutrophil count (ANC) \\\u003C 1,000\u002FμL. II. Platelet count \\\u003C 50,000\u002FµL (Platelet transfusions are not permitted to improve platelet count one week prior to study inclusion.) III. Serum Creatinine Clearance (CrCl) \\\u003C 30 mL\u002Fmin\u002F1,73m2. IV. Serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \\> 2.5 × upper limit of normal (ULN) (unless due to liver infiltration by myeloma cells), serum total bilirubin \\> 1.5 × ULN or \\> 3.0 mg\u002FdL for subjects with documented Gilbert's syndrome.\n\n   V. International ratio (INR) or partial thromboplastin time (PTT) \\> 1.5 × ULN, or history of Grade ≥ 2 hemorrhage within 30 days, or subject requires ongoing treatment with chronic, therapeutic dosing of anticoagulants (e.g. warfarin, low molecular weight heparin, or Factor Xa inhibitors).\n9. Echocardiogram (ECHO) with left ventricular ejection fraction \\\u003C 45%.\n10. An inadequate pulmonary function defined as oxygen saturation (Sa02) \\\u003C 92 % on room air\n11. Known to be HIV+ or to have hepatitis A, B, or C active infection.\n\n    Uncontrolled or active hepatitis B virus (HBV) infection: Patients with positive HBsAg and\u002For HBV DNA\n\n    Of note:\n\n    Patient can be eligible if anti-HBc immunoglobulin G (IgG) positive (with or without positive anti-HBs) but HBsAg and HBV DNA are negative.\n\n    If anti-HBV therapy in relation with prior infection was started before initiation of IMP, the anti-HBV therapy and monitoring should continue throughout the study treatment period.\n\n    Patients with negative HBsAg and positive HBV DNA observed during screening period will be evaluated by a specialist for start of anti-viral treatment: study treatment could be proposed if HBV DNA becomes negative and all the other study criteria are still met.\n\n    Active HCV infection: positive HCV RNA and negative anti-HCV\n\n    Of note:\n\n    Patients with antiviral therapy for HCV started before initiation of IMP and positive HCV antibodies are eligible. The antiviral therapy for HCV should continue throughout the treatment period until seroconversion.\n\n    Patients with positive anti-HCV and undetectable HCV RNA without antiviral therapy for HCV are eligible.\n12. Subjects with prior history of malignancies, other than MM, unless the subject has been free of the disease for ≥ 5 years.\n13. Subjects with severe polyneuropathy with accompanying pain\n14. Hypersensitivity or allergy against any of the study drugs.\n15. Contraindications against any of the study drugs as outlined in the Investigator brochure or equivalent.\n16. Prisoners or subjects who are legally institutionalized, or those unwilling or unable to comply with scheduled visits, drug administration plan, laboratory tests, other study procedures, and study restrictions.\n17. Participation in another interventional clinical trial during this trial or within 4 weeks before entry into this trial. There may be exceptions at the discretion of the (coordinating) investigator.\n18. Active systemic infection and severe infections requiring treatment with a parenteral administration of antibiotics.\n19. Any clinically significant, uncontrolled medical conditions that, in the Investigator's opinion, would expose the patient to excessive risk or may interfere with compliance or interpretation of the study results.\n20. Hypersensitivity or history of intolerance to steroids, mannitol, pregelatinized starch, sodium stearyl fumarate, histidine (as base and hydrochloride salt), arginine hydrochloride, poloxamer 188, sucrose or any of the other components of study intervention that are not amenable to premedication with steroids and H2 blockers or would prohibit further treatment with these agents.\n\n    \\-","70 Years",{"count":216,"type":22},100,[53,25],"Multiple myeloma (MM) is a malignant disease of the BM characterized by clonal expansion of plasma cells. Current guidelines recommend that newly diagnosed transplant-eligible patients with multiple myeloma (NDMMTE) shall undergo several cycles of induction, followed by one or two cycles high-dose melphalan followed by autologous stem cell transfusion (ASCT). Currently, induction therapy schemes usually consist of an immunomodulator (thalidomide or lenalidomide), a transmembrane glycoprotein CD38 targeting antibody, a proteasome inhibitor, and dexamethasone. The induction therapy is then followed by stem cell mobilization and subsequently one or two cycles of high-dose melphalan-chemotherapy based on the initial cytogenetic findings of the malignant plasma cells and the initial stage of the disease. Essentially, all NDMMTE patients undergo at least one cycle of high-dose chemotherapy, which is associated with high morbidity including acute toxicities like cytopenia, infection, and long-term effects such as myelodysplastic disease (MDS) and secondary malignancies and rarely death.\n\nBased on preliminary data and published reports, exposure to high-doses of the genotoxic agent melphalan might render the residual malignant myeloma cells into more aggressive clones, accelerating relapse by potentially altering stroma. Finally, exposure to melphalan is well known to increase the possibility of secondary malignant disease development. In MM patients, high-dose melphalan therapy improves OS and PFS if patients from all risk groups are taken in consideration. Yet, it remains to be answered, whether also low risk patients have an additional benefit from high-dose melphalan therapy or whether for these patients, a less toxic regime would be similarly sufficient with regard to PFS and OS. The challenging question will be whether the effect of melphalan on initial disease control might be outpaced by the negative effects as described above. Hence, the sponsor will explore whether treatment with high-dose melphalan might represent an overtreatment for certain subpopulation myeloma patients. These patients might be adequately treated without need of high-dose melphalan as part of the first line treatment. The sponsor, therefore, proposes to use a personalized approach to evaluate whether patients with a low-risk profile and with a gene expression profile indicating a standard risk of relapse might be sufficiently treated with an intensified induction course without subsequent upfront high-dose melphalan chemotherapy.",[28],"2024-12-05",{"date":222,"type":33},"2024-12-11",{"date":224,"type":33},"2023-02-03",{"date":226,"type":22},"2028-10",{"name":228,"class":40},"University Hopsital Schleswig Holstein Campus Lübeck",6,{"id":231,"slug":232,"hasResults":11,"nctId":233,"briefTitle":234,"officialTitle":235,"acronym":4,"eligibilityCriteria":236,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":237,"targetDuration":4,"studyType":239,"phases":4,"briefSummary":240,"conditions":241,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":242,"lastUpdatePostDateStruct":243,"startDateStruct":245,"completionDateStruct":247,"leadSponsor":249,"locationsCount":181},"100568509","conversion-to-carfilzomib-therapy-in-bortezomib-intolerant-newly-diagnosed-multiple-myelomandmm-patients-100568509","NCT06682156","Conversion to Carfilzomib Therapy in Bortezomib Intolerant Newly Diagnosed Multiple Myeloma(NDMM) Patients","Clinical Outcome of Multiple Myeloma Patients Switching to Carfilzomib-based Regimens After Prior Bortezomib-based First-line Therapy Intolerant, a Real-world, Single-arm, Prospective Study","Inclusion Criteria:\n\n1. ≥ 18 years of age\n2. Diagnosed with multiple myeloma according to IMWG criteria.\n3. Patients who have received only first-line bortezomib-based triple therapy, including bortezomib\u002Flenalidomide\u002Fdexamethasone (VRD), bortezomib\u002Fthalidomide\u002Fdexamethasone (VTD）,bortezomib\u002F cyclophosphamide\u002Fdexamethasone (VCD), and bortezomib\u002Fadriamycin\u002F\u002Fdexamethasone (PAD).\n4. Eastern cooperative oncology group(ECOG) score 0-2\n5. Patients who develop toxicities associated with bortezomib therapy evaluated by the investigator, including the presence of Grade 1 with pain or Grade 2 peripheral neuropathy (PN), Grade 3 hepatic impairment, Grade 3 diarrhea, and any other Grade 3 non-hematologic adverse events and resulting in bortezomib dose reduction or discontinuation.\n6. Patients who agree to and sign informed consents to participate in this study.\n\nExclusion Criteria:\n\n1. Patients currently participating in other interventional clinical studies (except those currently participating in non-interventional observational studies)\n2. Patients who have received prior carfilzomib treatment or participated in carfilzomib associated studies (with or without carfilzomib treatment).\n3. Patients with a primary diagnosis of MM combined with plasma cell leukemia (peripheral blood monoclonal plasma cells ≥5% of the total number of differentiated mature leukocytes)\n4. Patients who have not fully recovered from the reversible effects of prior chemotherapy (i.e., \\\u003C= grade 1 toxicity).\n5. Patients with other malignancies diagnosed prior to the MM diagnosis, excluding squamous and basal cell carcinomas of the skin, and carcinoma in situ of the cervix or breast, which can be cured within 3 years with minimal risk of recurrence.\n6. Patients with an active systemic infection, active hepatitis B or C virus infection, or known positive test results for human immunodeficiency virus.\n7. Evidence of current uncontrolled cardiovascular disease, including hypertension, arrhythmias (prolonged QT interval, ventricular tachycardia, ventricular flutter, ventricular fibrillation, frequent ventricular premature beats (24-hour premature loading of ≥15% of the total number of beats), grade Ⅲ atrioventricular block, and a heart rate of \\\u003C30-40 bpm congestive heart failure, unstable angina, or myocardial infarction in the past 3 months,. New York Heart Association (NYHA) class III and IV heart failure. left ventricle ejection fraction（LVEF） \\\u003C40% on cardiac ultrasound.\n8. Participants with known chronic obstructive pulmonary disease (COPD) (defined as forced expiratory volume in 1 second \\[FEV1\\] \\\u003C50% of predicted normal value), persistent asthma, or a history of asthma within the past 2 years (controlled intermittent asthma or mild persistent asthma that is allowed). Participants with known or suspected COPD must undergo FEV1 testing during screening.\n9. Inability to comply with protocol\u002Fprocedure.\n10. Patients with hypersensitivity to the active ingredient or excipients of carfilzomib.\n11. Pregnant or lactating women",{"count":238,"type":22},50,"OBSERVATIONAL","This is an open-label, single-arm, prospective study conducted in real-world clinical practice. It aims to evaluate the efficacy and safety in Chinese patients with newly diagnosed multiple myeloma who switch to carfilzomib-based regimens after bortezomib-based triple-drug regimen intolerance happens.",[28],"2024-11-07",{"date":244,"type":33},"2024-11-12",{"date":246,"type":33},"2024-09-10",{"date":248,"type":22},"2028-06-30",{"name":250,"class":40},"The First Affiliated Hospital of Soochow University"]