[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"newly-diagnosed-multiple-myeloma-ndmm\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:newly-diagnosed-multiple-myeloma-ndmm":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,50,81,105,131,157],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100524063","phase-2-18f-fluciclovine-petct-in-multiple-myeloma-100524063",false,"NCT06103838","18F-Fluciclovine PET\u002FCT in Multiple Myeloma","A Phase II Trial Evaluating 18F-Fluciclovine PET\u002FCT in Multiple Myeloma","* INCLUSION CRITERIA:\n* Participants must have a documented diagnosis of MM defined by the IMWG Criteria. Participants at diagnosis must have had a serum M-protein \\>= 3 g\u002FdL and\u002For bone marrow plasma cells \\>= 10% and at least one of the following:\n\n  * Anemia: Hemoglobin \\\u003C=10 g\u002FdL, or\n  * Renal Failure: serum creatinine \\>= 2.0 mg\u002FdL, or\n  * Hypercalcemia: Ca \\>= 10.5 mg\u002FdL, or\n  * Lytic bone lesions on X-ray, CT, or PET\u002FCT, or\n  * \\>= 2 focal lesions on spinal MRI, or\n  * \\>= 60% bone marrow plasma cells, or\n  * Involved\u002Fun-involved serum free light chain ration \\>= 100\n* Participants must have measurable disease defined by any one of the following:\n\n  * Monoclonal bone marrow plasma cells \\> 5%\n  * Serum monoclonal protein \\>= 0.2 g\u002Fdl\n  * Urine monoclonal protein \\> 200 mg\u002F24 hr\n  * Serum immunoglobulin free light chain \\> 10 mg\u002FdL AND abnormal kappa\u002Flambda ratio\n  * A measurable lesion on PET\u002FCT or MRI\n* Participants fit criteria for one of the following categories:\n\n  * Newly diagnosed multiple myeloma (NDMM)\n  * Relapsed and\u002For refractory multiple myeloma (RRMM) with at least 1 prior line of therapy\n* Age \\>=18 years.\n* ECOG performance status \\\u003C= 2\n* Negative serum or urine pregnancy test at screening for WOCBP.\n* Women of child-bearing potential and men must agree to use effective contraception (hormonal or barrier method of birth control; abstinence) 24 hours prior to and for the 24 hours after each 18F-fluciclovine administration.\n* Ability of subject to understand and the willingness to sign a written informed consent document.\n\nEXCLUSION CRITERIA:\n\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to 18F-FDG\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to 18F-fluciclovine or other similar agents.\n* Subjects with severe claustrophobia unresponsive to oral anxiolytics or unwilling to take them.\n* Uncontrolled intercurrent illness including, psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with 18F-fluciclovine, breastfeeding should be discontinued if the mother is treated with 18F-fluciclovine until 3 days after 18F-fluciclovine.","ALL","18 Years","120 Years",{"count":20,"type":21},60,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","Background:\n\nMultiple myeloma (MM) is an incurable cancer of certain blood cells. MM often returns after treatment, and most people survive only 5 to 8 years after diagnosis. To improve survival, researchers need to find ways to identify returning disease earlier.\n\nObjective:\n\nTo find out if the radiotracer 18F-fluciclovine (a substance injected into the blood during imaging scans) is better at detecting MM than the one (18F-FDG) currently used for this purpose.\n\nEligibility:\n\nAdults aged 18 years or older with MM. The MM may be newly diagnosed (NDMM); or it may have returned or failed to respond after at least 1 prior line of treatment (RRMM).\n\nDesign:\n\nParticipants will be screened. They will have blood tests. They will have a positron emission tomography (PET) or computed tomography (CT) scan using 18F-FDG. The radiotracer will be injected into a vein. Then participants will lie on a table while the PET\u002FCT scan takes images of their body.\n\nAll participants will have 3 study visits. During each visit they will have:\n\nTwo PET\u002FCT scans. One with 18F-FDG, one with 18F-fluciclovine.\n\nAn optional magnetic resonance imaging scan.\n\nA bone marrow biopsy. An area on the hip will be numbed; a needle will be inserted to draw out a sample of the soft tissue from inside the bone.\n\nThese tests may be spread over 30 days for each visit.\n\nNDMM participants will have their second study visit 2 to 4 weeks after they complete their usual treatment for the disease. RRMM participants will have their second visit 6 months after their first.\n\nAll participants will have a third study visit after 5 years or when their disease progresses.",[27,28,29],"Multiple Myeloma","Newly Diagnosed Multiple Myeloma (NDMM)","Relapsed and\u002For Refractory Multiple Myeloma (RRMM)",[31,32,33,34,35,36,27],"RRMM","NDMM","18F-FDG PET\u002FCT","PET\u002FCT","18F-fluciclovine","Imaging","RECRUITING","2026-06-27",{"date":40,"type":41},"2026-06-30","ACTUAL",{"date":43,"type":41},"2024-03-25",{"date":45,"type":21},"2032-12-06",{"name":47,"class":48},"National Cancer Institute (NCI)","NIH",1,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":58,"targetDuration":4,"studyType":22,"phases":60,"briefSummary":61,"conditions":62,"keywords":65,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":80},"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":59,"type":21},160,[24],"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.",[27,63,64,28],"Newly Diagnosed Multiple Myeloma","Transplant Ineligible",[32,66,56,67,68],"multiple myeloma","RVd lite","transplant ineligible\u002Fdeferred","NOT_YET_RECRUITING","2026-06-22",{"date":72,"type":41},"2026-06-23",{"date":74,"type":21},"2026-08-01",{"date":76,"type":21},"2035-12-01",{"name":78,"class":79},"Massachusetts General Hospital","OTHER",3,{"id":82,"slug":83,"hasResults":11,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":4,"eligibilityCriteria":87,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":88,"enrollmentInfo":89,"targetDuration":4,"studyType":22,"phases":91,"briefSummary":93,"conditions":94,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":49},"100642308","phase-1-safety-and-efficacy-of-rn1201-injection-as-first-line-treatment-for-newly-diagnosed-multiple-myeloma-100642308","NCT07652138","Safety and Efficacy of RN1201 Injection as First-Line Treatment for Newly Diagnosed Multiple Myeloma","An Exploratory Clinical Study on the Safety and Efficacy of RN1201 Injection as First-Line Treatment for Newly Diagnosed Multiple Myeloma","Inclusion Criteria:\n\n1. Willingness to participate in the trial and provide written informed consent.\n\n   * 2\\. Diagnosis of multiple myeloma (MM) per the 2017 revised WHO criteria.\n   * 3\\. BCMA-positive multiple myeloma documented at screening or in prior medical records.\n   * 4\\. Aged 18 - 70 years, any gender.\n   * 5\\. Life expectancy of at least 12 weeks.\n   * 6\\. Serum total bilirubin \\\u003C twice the upper limit of normal (ULN); serum creatinine within normal range;\n   * 7\\. alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \\\u003C three times ULN.\n   * 8\\. ECOG performance status score of 0 - 2.\n   * 9\\. Left ventricular ejection fraction (LVEF) ≥50% with no pericardial effusion.\n   * 10\\. Ability to adhere to the study visit schedule and protocol requirements.\n\nExclusion Criteria:\n\n1. Patients with serious active infections.\n\n   * 2\\. Subjects with acquired or congenital immunodeficiency.\n   * 3\\. Subjects with Class III\u002FIV heart failure per NYHA criteria.\n   * 4\\. Subjects with epilepsy or other central nervous system diseases.\n   * 5\\. Subjects with a history of primary cancer, except:\n\n     1. Resected non-melanoma (e.g., basal cell carcinoma)\n     2. Cured carcinoma in situ (e.g., cervical, bladder, breast cancer)\n   * 6\\. Systemic high-dose steroid use within 2 weeks before treatment.\n   * 7\\. Pregnant, breastfeeding women, or those planning pregnancy in 6 months.\n   * 8\\. Participation in other clinical trials within one month.\n   * 9\\. Major surgery within 14 days before the first study drug dose.\n   * 10\\. Any condition the investigator deems may raise subject risks or affect trial results.","70 Years",{"count":90,"type":21},18,[92],"PHASE1","This is a single-arm, dose-escalation exploratory study evaluating the safety and efficacy of RN1201, a BCMA\u002FCD19-targeted allogeneic CAR-T cell therapy, in patients with newly diagnosed multiple myeloma. Patients will receive lymphodepletion followed by a single infusion of RN1201. Primary endpoints include incidence and severity of treatment-emergent adverse events. Secondary endpoints assess response rate and minimal residual disease (MRD) status.",[95,28],"Multiple Myloma","2026-06-11",{"date":98,"type":41},"2026-06-16",{"date":100,"type":41},"2025-07-30",{"date":102,"type":21},"2027-11-30",{"name":104,"class":79},"The First Affiliated Hospital of Soochow University",{"id":106,"slug":107,"hasResults":11,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":111,"eligibilityCriteria":112,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":113,"targetDuration":115,"studyType":116,"phases":4,"briefSummary":117,"conditions":118,"keywords":119,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":49},"100615747","real-world-immuno-therapy-in-chinese-newly-diagnosed-multiple-myeloma-patients-100615747","NCT07296627","Real-world Immuno-therapy in Chinese Newly Diagnosed Multiple Myeloma Patients","A Prospective Study for Chinese Newly Diagnosed Multiple Myeloma Patients Treated With Immuno-therapy in Real-world Setting","PRIMARY","Inclusion Criteria:\n\n* Newly diagnosed multiple myeloma (NDMM)\n* Plan to receive first-line immunotherapy at the respective research center\n* First-line immunotherapy includes proteasome inhibitors (PI), immunomodulatory drugs (IMiDs), or anti-CD38 monoclonal antibodies, used alone or in combination with each other or with other treatments\n* Age ≥ 18 years\n* Ability to understand the purpose of the study and follow-up process\n* Willingness to provide signed and dated written informed consent\n\nExclusion Criteria:\n\n\\- Patients who did not receive any follow-up after initial diagnosis",{"count":114,"type":21},500,"12 Months","OBSERVATIONAL","To conduct a multicenter, prospective observational cohort study to investigate first-line immunotherapy patterns and clinical outcomes in NDMM patients in China. Leveraging the extensive patient resources of China's large center for blood disorders, the investigator will recruit approximately 500 NDMM patients to establish an NDMM patient cohort. The investigator will collect data on disease characteristics, treatment patterns, and clinical outcomes through one year of clinical follow-up. Further long-term follow-up is needed to obtain survival status and causes of death, so as to provide essential evidence for optimizing and improving patients' prognosis in clinical individualized treatment.",[28],[120,121],"Immuno-therapy","anti-CD38 monoclonal antibodies","2025-12-18",{"date":124,"type":41},"2025-12-22",{"date":126,"type":41},"2025-07-16",{"date":128,"type":21},"2027-11-15",{"name":130,"class":79},"Peking University People's Hospital",{"id":132,"slug":133,"hasResults":11,"nctId":134,"briefTitle":135,"officialTitle":136,"acronym":4,"eligibilityCriteria":137,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":138,"targetDuration":4,"studyType":22,"phases":140,"briefSummary":141,"conditions":142,"keywords":144,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":147,"lastUpdatePostDateStruct":148,"startDateStruct":150,"completionDateStruct":152,"leadSponsor":154,"locationsCount":156},"100601741","phase-1-rn1201-injection-in-newly-diagnosed-high-risk-cytogenetic-multiple-myeloma-100601741","NCT07114432","RN1201 Injection in Newly Diagnosed High-Risk Cytogenetic Multiple Myeloma","An Exploratory Clinical Study on the Safety and Efficacy of BCMA\u002FCD19 Allogeneic CAR-T Cell Injection in Newly Diagnosed High-Risk Cytogenetic Multiple Myeloma Patients Ineligible or Unwilling to Undergo ASCT","Inclusion Criteria:\n\n* A subject will be eligible for this trial only if all of the following criteria are met:\n\n  1. Is willing and able to provide a written informed consent form before any trial-related activities are performed.\n  2. Must have a diagnosis of Multiple Myeloma (MM) according to the World Health Organization (WHO) 2017 revised criteria.\n\n     * Must be diagnosed with active MM according to the International Multiple Myeloma Working Group (IMWG) criteria.\n     * Must meet the definition of genetic high-risk MM as per the \"2024 Chinese Expert Consensus on the Diagnosis and Treatment of High-Risk Multiple Myeloma\", defined as having one or more of the following high-risk cytogenetic abnormalities (HRCA) confirmed by FISH or mitotic karyotype analysis:\n\n     del(17p) TP53 mutation t(4;14) t(14;16) t(14;20) 1q21 gain\u002Famplification (defined as copy number ≥ 4) Del 1p Note: 1q21 amplification alone does not define cytogenetic high risk.\n  3. Must have a documented MM type that is B-cell maturation antigen (BCMA) positive and\u002For CD19 positive, confirmed at screening or from prior medical records.\n  4. Age ≥ 18 years, male or female.\n  5. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 at enrollment.\n  6. Has a life expectancy of ≥ 12 weeks.\n  7. Meets the following prior therapy requirements:\n\n     * Is currently receiving or has received an induction therapy regimen containing at least a proteasome inhibitor, an immunomodulatory agent, or a monoclonal antibody as a backbone therapy.\n     * Has not received more than 4 cycles of induction therapy at the time of enrollment.\n     * Has had an effective response to induction therapy without evidence of disease progression per IMWG criteria.\n     * Prior radiotherapy is permitted before enrollment.\n     * Is scheduled to initiate maintenance and\u002For consolidation therapy 3 months after cell reinfusion, following successful enrollment.\n  8. Must have measurable disease to assess Progression-Free Survival (PFS). Measurable disease is defined by at least one of the following criteria:\n\n     * Serum M-protein (M-spike) ≥ 0.5 g\u002FdL.\n     * 24-hour urine M-protein (M-spike) ≥ 200 mg.\n     * Abnormal serum free light chain (FLC) ratio with an involved FLC level ≥ 50 mg\u002FL.\n     * For IgA MM: total serum IgA level outside the normal range.\n     * Note: The presence of measurable disease is not required at enrollment; it can be determined from historical lab data. For instance, a subject who achieved a complete response after induction and has no measurable disease at enrollment is still eligible if they met any of the above criteria after their initial diagnosis.\n  9. Adequate organ function as defined by the following laboratory values:\n\n     * Total serum bilirubin \\\u003C 2 times the upper limit of normal (ULN).\n     * Serum creatinine \\\u003C ULN.\n     * Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) \\\u003C 3 times ULN.\n  10. Estimated or calculated creatinine clearance (CrCl) ≥ 40 mL\u002Fmin, via CKD-EPI or Cockcroft-Gault formula.\n  11. Diffusing capacity of the lungs for carbon monoxide (DLCO) ≥ 50% of predicted value (corrected or uncorrected for anemia\u002Falveolar volume).\n  12. Adequate bone marrow function defined as: Absolute neutrophil count ≥ 0.5×10⁹\u002FL and platelet count ≥ 20×10⁹\u002FL.\n  13. ECOG performance status of 0-2.\n  14. Left ventricular ejection fraction (LVEF) ≥ 50% with no pericardial effusion.\n  15. Must have recovered to ≤ Grade 1 (per CTCAE) from any Serious Adverse Event (SAE) before enrollment.\n  16. Able to comply with the study visit schedule and other protocol requirements.\n\nExclusion Criteria:\n\n* A subject will not be eligible for this trial if any of the following criteria are met:\n\n  1. Known history of allergic reaction, hypersensitivity, intolerance, or contraindication to the BCMA\u002FCD19 allogeneic CAR-T product or any of its excipients, including fludarabine, cyclophosphamide, and tocilizumab.\n  2. Diagnosis of plasma cell leukemia.\n  3. Presence of non-paraskeletal extramedullary disease.\n  4. Relapse after allogeneic hematopoietic stem cell transplantation (allo-HSCT) with active graft-versus-host disease (GVHD) that requires treatment with steroids or immunosuppressive agents.\n  5. Presence of a severe, active infection, including:\n\n     * Human Immunodeficiency Virus (HIV) infection (subjects must have a negative HIV 1\u002F2 antibody screen).\n     * Hepatitis C Virus (HCV) infection (subjects must have a negative anti-HCV antibody screen).\n     * Hepatitis B Virus (HBV) infection (subjects must have a negative HBsAg screen).\n  6. History of prior gene therapy or genetically modified cell immunotherapy.\n  7. Active autoimmune disease, including connective tissue disease, uveitis, sarcoidosis, inflammatory bowel disease, or multiple sclerosis; or a history of a severe autoimmune disease (as judged by the Principal Investigator) that required long-term immunosuppressive therapy.\n  8. Diagnosis of an acquired or congenital immunodeficiency disease.\n  9. History of Class III or IV heart failure as defined by the New York Heart Association (NYHA), unstable angina, myocardial infarction within the last 6 months, or sustained (\\>30 seconds) ventricular arrhythmia.\n  10. History of seizure disorder or other central nervous system (CNS) disease; history or current evidence of CNS involvement with MM. Note: CNS screening (e.g., lumbar puncture) is not mandatory unless symptoms are present.\n  11. History of other primary malignancies, except for the following:\n\n      * Non-melanoma skin cancer (e.g., basal cell carcinoma) cured by resection.\n      * Carcinoma in situ (e.g., cervical, bladder, or breast cancer) that has been cured.\n  12. Is pregnant, breastfeeding, or, for female subjects, is planning a pregnancy within 6 months.\n  13. Participation in another clinical trial within the last month.\n  14. Any condition which, in the opinion of the investigator, would place the subject at increased risk or interfere with the trial results.\n  15. Has undergone major surgery within 14 days prior to the first dose of the study drug.",{"count":139,"type":21},19,[92],"This is a single-arm, dose-escalation exploratory study evaluating the safety and efficacy of RN1201, a BCMA\u002FCD19-targeted allogeneic CAR-T cell therapy, in patients with newly diagnosed cytogenetically high-risk multiple myeloma who are ineligible or unwilling to undergo autologous stem cell transplantation (ASCT). Patients will receive lymphodepletion followed by a single infusion of RN1201 across four dose levels. Primary endpoints include incidence and severity of treatment-emergent adverse events. Secondary endpoints assess response rate and minimal residual disease (MRD) status.",[143,28],"Newly Diagnosed High-Risk Cytogenetic Multiple Myeloma Patients Ineligible or Unwilling to Undergo ASCT",[145,146,27],"Newly Diagnosed","High-Risk Cytogenetic","2025-08-03",{"date":149,"type":41},"2025-08-11",{"date":151,"type":21},"2025-08",{"date":153,"type":21},"2028-08",{"name":155,"class":79},"Tianjin Medical University Cancer Institute and Hospital",2,{"id":158,"slug":159,"hasResults":11,"nctId":160,"briefTitle":161,"officialTitle":162,"acronym":163,"eligibilityCriteria":164,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":165,"targetDuration":4,"studyType":116,"phases":4,"briefSummary":167,"conditions":168,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":169,"lastUpdatePostDateStruct":170,"startDateStruct":172,"completionDateStruct":174,"leadSponsor":176,"locationsCount":178},"100599705","positron-emission-tomography-with-innovative-laboratory-techniques-for-improved-risk-and-disease-assessment-in-newly-diagnosed-multiple-myeloma-patients-100599705","NCT07087964","Positron Emission Tomography With Innovative Laboratory Techniques for Improved Risk and Disease Assessment in Newly Diagnosed Multiple Myeloma Patients","Positron Emission Tomography With Innovative Laboratory Techniques for Improved Risk and Disease Assessment in Myeloma","IMMPROVED","Inclusion Criteria:\n\n* Transplant-eligible newly diagnosed multiple myeloma based on current IMWG criteria and scheduled for induction chemotherapy followed by ASCT. Remark: patiënts can also be included after ASCT, prior to maintenance therapy, if a baseline FDG-PET CT scan showing FDG avid disease is available.\n* Baseline 18F-FDG PET\u002FWBLDCT scan should be performed before start of treatment (preferably) or within 7 days after start of treatment. Scan must show FDG avid disease (=at least 1 FL ≥ DS3 and\u002For diffuse bone marrow involvement).\n* WHO performance status 0-2 (WHO \\> 2 can be allowed if due to underlying disease and after discussion with the physician).\n* Age ≥ 18 years\n* Life expectancy \\> 12 months, based on clinical judgement.\n\nEligibility criteria for the primary endpoint\n\n* achieving at least a VGPR after induction chemotherapy and ASCT according to the standard IMWG response criteria.\n* received at least one (28-day) cycle of lenalidomide as maintenance therapy after ASCT. No new therapy can be given until clinical relapse.\n\nExclusion Criteria:\n\n* Any physical or physiological condition that may affect adherence to the study protocol, e.g. severe claustrophobia or the inability to lie still for 30 minutes.\n* uncontrolled diabetes\n* History of concomitant presence of any other malignancy, except for:\n\n  * non-melanoma skin cancer\n  * carinoma in situ of the cervix\n  * any other effectively treated malignancy that has been in remission for \\> 5 years or that is highly likely to be cured at the time of enrollment.\n* pregnant or breastfeeding\n* refusal or inability to provide written informed consent",{"count":166,"type":21},120,"This study investigates newly diagnosed multiple myeloma patients following standard of care treatment. The primary endpoint of the study is to determine minimal residual disease (MRD) by combining 2 techniques in order to better predict progression free survival (PFS) of a patient. Secondary endpoint is to gain more insight into diagnostic features to better stratify patients based on risk factors for early relapse. Both endpoints could lead to a more patient specific treatment in the future.\n\nParticipants will be followed throughout their standard of care treatment. This treatment consists of indcution chemotherapy, followed by autologous stem cell transplant (ASCT), followed by lenalidomide maintenance therapy.\n\n* Before start of induction chemotherapy the patient will receive a whole-body FDG PET\u002FLDCT scan and an additional bone marrow aspirate sample will be taken during a routine bone marrow punction. This sample will be used for whole exome sequencing (WES).\n* For those patients who achieve at least a very good partial response (VGPR) after induction chemotherapy and ASCT a repeat whole body FDG PET\u002FLDCT scan will be performed before start of maintenance therapy. This scan will be repeated for a third time after 1 year of maintenance therapy. Besides this, an additional bone marrow aspirate sample will be taken for MRD detection. This will be done before start of maintenance therapy, after 1 year of maintenance therapy and after 2 years of maintenance therapy. MRD detection is done by next generation flow cytometery (NGF).\n* During mantenance therapy patient follow-up will be performed at least every 3 months to determine best response to therapy or possible relapse (based on routine lab information).\n* Those patients who do not achieve VGPR or better will not need to receive a whole body FDG PET\u002FCT scan and MRD detection by flow cytometry, but these patients will undergo the same follow-up during maintenance therapy.\n* In case of relapse, for all patients, an additional bone marrow aspirate sample will be taken for WES (during a routine bone marrow investigation).",[28],"2025-07-23",{"date":171,"type":41},"2025-07-28",{"date":173,"type":41},"2022-05-16",{"date":175,"type":21},"2028-12-31",{"name":177,"class":79},"Universiteit Antwerpen",4]