[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"refractory-plasma-cell-myeloma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:refractory-plasma-cell-myeloma":42},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,58,81,106],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":46,"lastUpdatePostDateStruct":47,"startDateStruct":50,"completionDateStruct":52,"leadSponsor":54,"locationsCount":57},"100287143","phase-1-a-vaccine-vsv-hifn-nis-with-or-without-cyclophosphamide-and-combinations-of-ipilimumab-nivolumab-and-cemiplimab-in-treating-relapsed-or-refractory-multiple-myeloma-acute-myeloid-leukemia-or-lymphoma-100287143",false,"NCT03017820","A Vaccine (VSV-hIFNβ-NIS) With or Without Cyclophosphamide and Combinations of Ipilimumab, Nivolumab, and Cemiplimab in Treating Relapsed or Refractory Multiple Myeloma, Acute Myeloid Leukemia or Lymphoma","MC1684 Phase I Trial of Systemic Administration of Vesicular Stomatitis Virus Genetically Engineered to Express NIS and Human Interferon, in Patients With Relapsed or Refractory Multiple Myeloma, Acute Myeloid Leukemia, Lymphomas, or Histiocytic\u002FDendritic Cell Neoplasms","Inclusion Criteria:\n\n* Age \\>= 18 years\n* Relapsed or refractory disease as follows:\n\n  * Groups A, B, C or D: Multiple myeloma (MM) previously treated with an immunomodulatory imide drug (IMID), a proteosome inhibitor, and an alkylating agent\n  * All Groups except D: Relapsed peripheral T-cell lymphoma (PTCL) of the following histologies: peripheral T-cell lymphoma-NOS (PTCL-NOS); angioimmunoblastic T-cell lymphoma (AITL), anaplastic large cell (ALCL), and mycosis fungoides (MF). Patients should have failed standard therapy and in the case of PTCL-NOS, AITL, and ALCL either have failed or be ineligible for high-dose therapy with autologous stem cell transplant\n  * Group B and C only: B-cell lymphoma (other than Burkitt's lymphoma), or histiocytic\u002Fdendritic cell neoplasms (HCN) at any stage\n  * Group E only: Relapsed peripheral T-cell lymphoma (PTCL) of the following histologies: peripheral T-cell lymphoma-NOS (PTCL-NOS); anaplastic large cell (ALCL), and mycosis fungoides (MF)\n  * Group F only: Expansion Cohort for B-cell lymphoma (other than Burkitt's lymphoma) with low tumor burden\n  * Group G only: Expansion Cohort for peripheral T cell lymphoma (PTCL) with low tumor burden\n* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =\\\u003C 2 times upper limit of normal (ULN) (obtained =\\\u003C 15 days prior to registration)\n* Creatinine =\\\u003C 2.0 mg\u002FdL (obtained =\\\u003C 15 days prior to registration)\n* Direct bilirubin =\\\u003C 1.5 x ULN (obtained =\\\u003C 15 days prior to registration)\n* International normalized ratio (INR)\u002Fprothrombin time (PT) and activated partial thromboplastin time (aPTT) =\\\u003C 1.5 x ULN (obtained =\\\u003C 15 days prior to registration)\n* If baseline liver disease, Child Pugh score not exceeding class A (obtained =\\\u003C 15 days prior to registration)\n* Negative pregnancy test for persons of child-bearing potential (obtained =\\\u003C 15 days prior to registration)\n* FOR MULTIPLE MYELOMA ONLY: Measurable disease of multiple myeloma as defined by at least ONE of the following:\n\n  * Serum monoclonal protein \\>= 1.0 g\u002FdL by protein electrophoresis\n  * \\>= 200 mg of monoclonal protein in the urine on 24-hour electrophoresis\n  * Serum immunoglobulin free light chain \\>= 10 mg\u002FdL AND abnormal serum immunoglobulin kappa to lambda free light chain ratio\n* FOR MULTIPLE MYELOMA ONLY: Absolute neutrophil count (ANC) \\>= 1000\u002FuL (obtained =\\\u003C 14 days prior to registration)\n* FOR MULTIPLE MYELOMA ONLY: Platelet (PLT) \\>= 100,000\u002FuL (obtained =\\\u003C 14 days prior to registration)\n* FOR MULTIPLE MYELOMA ONLY: Hemoglobin \\>= 8.5 g\u002Fdl (obtained =\\\u003C 14 days prior to registration)\n* FOR AML ONLY: No ANC restriction (obtained =\\\u003C 14 days prior to registration)\n* FOR AML ONLY: PLT \\>= 10,000\u002FuL (transfusion to get platelets \\>= 10,000 is allowed) (obtained =\\\u003C 14 days prior to registration)\n* FOR AML ONLY: Hemoglobin \\>= 7.5 g\u002Fdl (obtained =\\\u003C 14 days prior to registration)\n* FOR AML ONLY: Absence of uncompensated disseminated intravascular coagulation (DIC- as diagnosed by standard International Society on Thrombosis and Hemostasis \\[ISTH\\] criteria)\n* FOR TCL\u002FBCL ONLY: ANC \\>= 1,000\u002FuL (obtained =\\\u003C 14 days prior to registration)\n* FOR TCL\u002FBCL ONLY: PLT \\>= 100,000\u002FuL (obtained =\\\u003C 14 days prior to registration)\n* FOR TCL\u002FBCL ONLY: Hemoglobin \\>= 8.5 g\u002Fdl (obtained =\\\u003C 14 days prior to registration)\n* FOR TCL\u002FBCL ONLY: Measurable disease by CT or magnetic resonance imaging (MRI): must have at least one lesion that has a single diameter of \\> 2 cm or tumor cells in the blood \\> 5 x 10\\^9\u002FL; NOTE: skin lesions can be used if the area is \\> 2 cm in at least one diameter and photographed with a ruler and the images are available in the medical record\n* FOR HCN ONLY: ANC \\>= 1,000\u002FuL obtained =\\\u003C 15 days prior to registration\n* FOR HCN ONLY: PLT \\>= 100,000\u002FuL obtained =\\\u003C 15 days prior to registration\n* FOR HCN ONLY: Hemoglobin \\>= 8.0 g\u002Fdl obtained =\\\u003C 15 days prior to registration\n* FOR HCN ONLY: Measurable disease by CT or MRI: Must have at least one lesion that has a single diameter of \\>= 1.5 cm or tumor cells in the blood \\>5 x10\\^9\u002FL. NOTE: Skin lesions can be used if the area is \\>= 1.5 cm in at least one diameter and photographed with a ruler and the images are available in the medical record\n* Absence of active central nervous system (CNS) involvement; NOTE: pre-enrollment lumbar puncture not mandatory\n* Ability to provide written informed consent\n* Willingness to return to Mayo Clinic for follow-up\n* Life expectancy \\>= 12 weeks\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2\n* Willing to provide mandatory biological specimens for research purposes\n\nExclusion Criteria:\n\n* Availability of and patient acceptance of curative therapy\n* Uncontrolled infection\n* Active tuberculosis or hepatitis, or chronic hepatitis\n* Any of the following prior therapies:\n\n  * Chemotherapy (IMIDs, alkylating agents, proteosome inhibitors) =\\\u003C 2 weeks prior to registration\n  * Immunotherapy (monoclonal antibodies) =\\\u003C 4 weeks prior to registration\n  * Experimental agent in case of AML or TCL within 4 half-lives of the last dose of the agent\n* New York Heart Association classification III or IV, known symptomatic coronary artery disease, or symptoms of coronary artery disease on systems review, or known cardiac arrhythmias (atrial fibrillation or supraventricular tachycardia \\[SVT\\])\n* Active CNS disorder or seizure disorder or known CNS disease or neurologic symptomatology; in case of AML active CNS involvement as detected by lumbar puncture or neuro-imaging (only to be done if clinically indicated)\n* Human immunodeficiency virus (HIV) positive test result or other immunodeficiency or immunosuppression\n* Other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy considered investigational (used for a non-Food and Drug Administration \\[FDA\\] approved indication and in the context of a research investigation);\n\n  * NOTE: in AML, the concurrent use of hydroxyurea to help control proliferative counts is allowed throughout the treatment protocol;\n  * NOTE: in TCL, patients may use topical emollients or corticosteroids, acetic acid soaks, etc. to control pruritus and prevent infection; no topical chemotherapy is allowed (no topical nitrogen mustard)\n* Any of the following because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown:\n\n  * Pregnant women or women of reproductive ability who are unwilling to use effective contraception\n  * Nursing women\n  * Men who are unwilling to use a condom (even if they have undergone a prior vasectomy) while having intercourse with any woman, while taking the drug and for 4 weeks after stopping treatment\n* AML ONLY: Current disseminated intravascular coagulopathy (DIC)\n* ADDITIONAL EXCLUSION CRITERIA FOR GROUP A (LOW TUMOR BURDEN) ONLY:\n\n  * Diagnosis of AML\n  * Multiple myeloma only: \\> 25% plasma cells or plasmacytoma \\> 5cm in largest diameter\n  * Lymphoma or HCN only: Any mass \\>5cm\n  * Diagnosis of Burkitt's lymphoma\n* ADDITIONAL EXCLUSION CRITERIA FOR GROUP B (HIGH TUMOR BURDEN) ONLY:\n\n  * Diagnosis of AML\n  * Diagnosis of Burkitt's lymphoma\n* ADDITIONAL EXCLUSION CRITERIA FOR GROUP C (COMBINATION WITH CYCLOPHOSPHAMIDE) ONLY:\n\n  * Diagnosis of AML\n  * Diagnosis of Burkitt's lymphoma\n* ADDITIONAL EXCLUSION CRITERIA FOR GROUP E (COMBINATION WITH CEMIPLIMAB) ONLY:\n\n  * Diagnosis of AML\n  * Diagnosis of AITL\n* ADDITIONAL EXCLUSION CRITERIA FOR GROUP F (BCL EXPANSION COHORT) ONLY:\n\n  * Diagnosis of Burkitt's lymphoma\n* ADDITIONAL EXCLUSION CRITERIA FOR GROUP G (PTCL EXPANSION COHORT) ONLY:\n\n  * Diagnosis of cutaneous TCL","ALL","18 Years",{"count":19,"type":20},99,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","This phase I trial studies the best dose and side effects of the VSV-hIFNβ-NIS vaccine with or without cyclophosphamide and combinations of ipilimumab, nivolumab, and cemiplimab in treating patients with multiple myeloma, acute myeloid leukemia or lymphoma that has come back after a period of improvement (relapsed) or that does not respond to treatment (refractory). VSV-IFNβ-NIS is a modified version of the vesicular stomatitis virus (also called VSV). This virus can cause infection and when it does it typically infects pigs, cattle, or horses but not humans. The VSV used in this study has been altered by having two extra genes (pieces of DNA) added. The first gene makes a protein called NIS that is inserted into the VSV. NIS is normally found in the thyroid gland (a small gland in the neck) and helps the body concentrate iodine. Having this additional gene will make it possible to track where the virus goes in the body (which organs). The second addition is a gene for human interferon beta (β) or hIFNβ. Interferon is a natural anti-viral protein, intended to protect normal healthy cells from becoming infected with the virus. VSV is very sensitive to the effect of interferon. Many tumor cells have lost the capacity to either produce or respond to interferon. Thus, interferon production by tumor cells infected with VSV-IFNβ-NIS will protect normal cells but not the tumor cells. The VSV with these two extra pieces is referred to as VSV-IFNβ-NIS. Cyclophosphamide is in a class of medications called alkylating agents. It works by damaging the cell's DNA and may kill cancer cells. It may also lower the body's immune response. Immunotherapy with monoclonal antibodies, such as ipilimumab, nivolumab, and cemiplimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving VSV-IFNβ-NIS with or without cyclophosphamide and combinations of ipilimumab, nivolumab, and cemiplimab may be safe and effective in treating patients with recurrent peripheral T-cell lymphoma.",[26,27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44],"B-Cell Non-Hodgkin Lymphoma","Histiocytic and Dendritic Cell Neoplasm","Myelodysplastic Syndrome","Previously Treated Myelodysplastic Syndrome","Recurrent Adult Acute Myeloid Leukemia","Recurrent Anaplastic Large Cell Lymphoma","Recurrent Angioimmunoblastic T-Cell Lymphoma","Recurrent Mycosis Fungoides","Recurrent Plasma Cell Myeloma","Recurrent Primary Cutaneous T-Cell Non-Hodgkin Lymphoma","Recurrent T-Cell Non-Hodgkin Lymphoma","Refractory Acute Myeloid Leukemia","Refractory Anaplastic Large Cell Lymphoma","Refractory Angioimmunoblastic T-Cell Lymphoma","Refractory Mycosis Fungoides","Refractory Peripheral T-Cell Lymphoma, Not Otherwise Specified","Refractory Plasma Cell Myeloma","Refractory Primary Cutaneous T-Cell Non-Hodgkin Lymphoma","Refractory T-Cell Non-Hodgkin Lymphoma","RECRUITING","2026-06-08",{"date":48,"type":49},"2026-06-10","ACTUAL",{"date":51,"type":49},"2017-04-04",{"date":53,"type":20},"2032-04-01",{"name":55,"class":56},"Mayo Clinic","OTHER",2,{"id":59,"slug":60,"hasResults":11,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":4,"eligibilityCriteria":64,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":65,"targetDuration":4,"studyType":21,"phases":67,"briefSummary":69,"conditions":70,"keywords":4,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":80},"100401557","phase-2-leflunomide-pomalidomide-and-dexamethasone-for-the-treatment-of-relapsed-or-refractory-multiple-myeloma-100401557","NCT04508790","Leflunomide, Pomalidomide, and Dexamethasone for the Treatment of Relapsed or Refractory Multiple Myeloma","A Phase 2 Trial of Leflunomide, Pomalidomide, and Dexamethasone for Relapsed\u002FRefractory Multiple Myeloma","Inclusion Criteria:\n\n* Documented informed consent of the participant and\u002For legally authorized representative\n\n  * Assent, when appropriate, will be obtained per institutional guidelines\n* Agreement to allow the use of archival tissue from diagnostic tumor biopsies\n\n  * If unavailable, exceptions may be granted with study principal investigator (PI) approval\n* Eastern Cooperative Oncology Group (ECOG) =\\\u003C 2\n* Life expectancy \\> 3 months\n* Diagnosis of multiple myeloma with measurable disease as defined by:\n\n  * M-protein quantities \\>= 0.5 g\u002FdL by serum protein electrophoresis (sPEP) or\n  * \\>= 200 mg\u002F24 hour urine collection by urine protein electrophoresis (uPEP) or\n  * Serum free light chain (FLC) \\> 10.0 mg\u002FdL involved light chain and an abnormal kappa\u002Flambda ration in subjects without detectable serum or urine M-protein or\n  * For subjects with immunoglobulin class A (IgA) myeloma whose disease can only be reliably measured by quantitative immunoglobulin measurement, a serum IgA level \\>= 0.50 g\u002FdL\n* Relapsed or refractory to at least 1 prior line of therapy, including both a proteasome inhibitor and an immunomodulatory drug, and for whom transplant is not recommended. Participants may opt for a delayed transplant at a later time, if appropriate\n* Fully recovered from the acute toxic effects (except alopecia) to =\\\u003C grade 2 to prior anti-cancer therapy\n* Absolute neutrophil count (ANC) \\>= 1.0 x 10\\^9\u002FL (performed within 30 days prior to day 1 of protocol therapy unless otherwise stated)\n\n  * NOTE: Screening ANC should be independent of granulocyte- and granulocyte\u002Fmacrophage colony stimulating factor (G-CSF and GM-CSF) support for at least 1 week and of pegylated G-CSF for at least 2 weeks\n* Platelets \\>= 75.0 x 10\\^9\u002FL (performed within 30 days prior to day 1 of protocol therapy unless otherwise stated)\n\n  * NOTE: Screening platelet count should be independent of platelet transfusions for at least 2 weeks\n* Hemoglobin \\>= 8.0 g\u002FdL (performed within 30 days prior to day 1 of protocol therapy unless otherwise stated)\n\n  * NOTE: Transfusion support is allowed\n* Total bilirubin =\\\u003C 2 X upper limit of normal (ULN) (unless has Gilbert's disease) (performed within 30 days prior to day 1 of protocol therapy unless otherwise stated)\n* Aspartate aminotransferase (AST) =\\\u003C 3.5 x ULN (performed within 30 days prior to day 1 of protocol therapy unless otherwise stated)\n* Alanine aminotransferase (ALT) =\\\u003C 3.5 x ULN (performed within 30 days prior to day 1 of protocol therapy unless otherwise stated)\n* Alkaline phosphatase \\\u003C 5 x ULN (performed within 30 days prior to day 1 of protocol therapy unless otherwise stated)\n* Creatinine clearance of \\>= 30 mL\u002Fmin per 24 hour urine test (performed within 30 days prior to day 1 of protocol therapy unless otherwise stated)\n* Women of childbearing potential (WOCBP): negative urine or serum pregnancy test\n\n  * If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required\n* Agreement by females and males of childbearing potential to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 4 weeks after the last dose of protocol therapy\n\n  * Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \\> 1 year (women only)\n\nExclusion Criteria:\n\n* Prior treatment with leflunomide\n* Patients who are pomalidomide refractory, defined as subjects who progress on or within 60 days of pomalidomide when given as a single agent or in combinatorial therapies. Prior exposure to pomalidomide without refractoriness is allowed\n* Current or planned use of other anti-myeloma therapies besides leflunomide, pomalidomide, and dexamethasone\n* Current or planned growth factor or transfusion support until after initiation of treatment\n* Prior allogeneic transplant\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agents\n* Positive for tuberculosis or latent tuberculosis (TB)\n* Positive for hepatitis A, B, or C\n* Known human immunodeficiency virus (HIV) infection\n* Prior diagnosis of rheumatoid arthritis\n* Acute active infection requiring systemic therapy within 2 weeks prior to enrollment\n* Subject has history of anaphylaxis to thalidomide, lenalidomide, pomalidomide, cholestyramine or dexamethasone\n* Non-hematologic malignancies within the past 3 years, with the exceptions of\n\n  * Adequately treated basal cell or squamous cell skin cancer,\n  * Carcinoma in situ of the cervix,\n  * Prostate cancer \\\u003C Gleason grade 6 with stable prostate specific antigen (PSA), or\n  * Successfully treated in situ carcinoma of the breast\n* Females only: Pregnant or breastfeeding\n* Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures\n* Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility\u002Flogistics)",{"count":66,"type":20},29,[68],"PHASE2","This phase II trial studies how well leflunomide, pomalidomide, and dexamethasone work for the treatment of multiple myeloma that has come back (relapsed) or does not respond to treatment (refractory). Leflunomide may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Immunotherapy with pomalidomide, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving leflunomide with pomalidomide and dexamethasone may work better in treating multiple myeloma compared to pomalidomide and dexamethasone alone.",[34,42],"2026-05-27",{"date":73,"type":49},"2026-05-29",{"date":75,"type":49},"2020-11-24",{"date":77,"type":20},"2027-02-14",{"name":79,"class":56},"City of Hope Medical Center",8,{"id":82,"slug":83,"hasResults":11,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":4,"eligibilityCriteria":87,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":88,"targetDuration":4,"studyType":21,"phases":90,"briefSummary":92,"conditions":93,"keywords":4,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":105},"100463250","non-chemotherapeutic-interventions-for-the-improvement-of-quality-of-life-and-immune-function-in-patients-with-multiple-myeloma-100463250","NCT05312255","Non-chemotherapeutic Interventions for the Improvement of Quality of Life and Immune Function in Patients With Multiple Myeloma","Improving Host Factors in Patients With Monoclonal Gammopathies and Other Hematologic Disorders","Inclusion Criteria:\n\n* Age \\>= 18 years of age\n* Have an Eastern Cooperative Oncology Group (ECOG) Performance Status of:\n\n  * Module A: ECOG 0 - 1\n  * Module B: ECOG 0 - 2\n  * Module C: ECOG 0 - 2\n  * Module D: ECOG 0-1\n* MODULE A, B and C: Have a diagnosis of smoldering multiple myeloma, multiple myeloma or plasma cell leukemia (PCL) or\n* MODULE D: non transfusion dependent low-risk MDS\n* Show no signs of comorbidities, myeloma symptoms, or treatment side effects that would put them in danger when participating in the study according to the physician's discretion\n* Are able to understand and follow assessment and intervention procedures\n* Participant must understand the investigational nature of this study and sign an Independent Ethics Committee\u002FInstitutional Review Board approved written informed consent form prior to receiving any study related procedure\n* MODULE A and D (PHYSICAL ACTIVITY): Participant has access to a personal computer or tablet with camera, microphone, speakers and internet access\n* MODULE B (NUTRITION): Not applicable\n* MODULE C (BETA BLOCKER): Newly diagnosed patients with multiple myeloma necessitating treatment and before initiation of systemic therapy\n* MODULE C: Female participants of child-bearing potential must have a negative pregnancy test at study entry and then agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry. Male patients with female partners of child-bearing potential should also use adequate contraceptive methods (see above). Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately MODULE D: Patients with MDS not necessitating transfusion therapy at time of enrollment (no transfusion within 8 weeks prior to enrollment) i.e. patients on observation, or receiving growth factors or luspatercept only\n\nExclusion Criteria:\n\n* Major comorbidities that would cause danger to the patient when participating in the study and that would have a risk of progression if the patient took part in the study (including, but not limited to): cardiac or pulmonary and infectious diseases (e.g., ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia) or, psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* Unwilling or unable to follow protocol requirements\n* Any condition which in the investigator's opinion deems the participant an unsuitable candidate to take part in study intervention (comorbidities, myeloma symptoms, treatment side effects)\n* MODULE A (PHYSICAL ACTIVITY): Current and symptomatic pathological fracture(s) or severely advanced instability of the musculo-skeletal system that is deemed to making the patient unsafe to participate. This will be assessed by radiologist, a neurosurgeon and\u002For an orthopedic surgeon, if applicable.\n* MODULE A (PHYSICAL ACTIVITY): Current and symptomatic pathological fracture(s) or severely advanced instability of the musculo-skeletal system\n* MODULE A (PHYSICAL ACTIVITY): Acute bone instability as assessed by whole body low-dose computed tomography and evaluated by an experienced surgeon\n* MODULE B (NUTRITION): Clinical signs of malnutrition (body mass index \\[BMI\\] \\\u003C 18)\n* MODULE B (NUTRITION): Special diets (physician prescribed)\n* MODULE B (NUTRITION): Diabetic treated with glucose-lowering medications and\u002For insulin\n* MODULE B (NUTRITION): Other reasons not to withhold food\n* MODULE B (NUTRITION): Any condition which in the investigator's opinion deems the participant an unsuitable candidate to limit food consumption\n* MODULE C (BETA BLOCKER): Current use of a beta blocker (includes all non-selective and beta-1 selective blockers) or, use of a beta-blocker within 3 months of study enrollment\n* MODULE C (BETA BLOCKER): Contraindications to the use of beta-blockers, e.g.; severe sinus bradycardia; sick sinus syndrome; or heart block greater than first-degree, uncontrolled depression, unstable angina pectoris, uncontrolled heart failure (New York Heart Association \\[NYHA\\] Grade III or IV), hypotension ( systolic blood pressure \\\u003C 100 mmHg), severe asthma or chronic obstructive pulmonary disease (COPD), uncontrolled type I or type II diabetes mellitus (HbA1C \\> 8.5 or 12h fasting plasma glucose \\> 160 mg\u002FdL at screening), symptomatic peripheral arterial disease or Raynaud's syndrome, untreated pheochromocytoma, current calcium channel blocker use (Non-dihydropyridines such as verapamil) or rhythm control agents such as digoxin and amiodarone. Patients with pacemakers will be excluded\n* MODULE C (BETA BLOCKER): Pregnant or nursing female participants, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test\n* MODULE D: Cardiovascular disease which is deemed limiting exercise readiness by a cardiologist",{"count":89,"type":20},175,[91],"NA","This clinical trial investigates the effect of non-chemotherapeutic interventions in patients with multiple myeloma or MDS. Non-chemotherapeutic interventions such as physical activity and nutritional interventions (e.g., modifications in diet) have been shown to positively affect the immune system and improve overall quality of life. Another purpose of this study is for researchers to learn how the addition of a beta-blocker (propranolol) to the standard treatment regimen in patients with newly diagnosed multiple myeloma affects immune response and quality of life. A study from the Mayo Clinic looked at multiple myeloma patients who were on a beta-blocker while undergoing chemotherapy and found that the use of a beta-blocker resulted in improved patient survival outcomes. Non-chemotherapeutic treatment options may help decrease symptoms and improve quality of life for patients with multiple myeloma.",[94,34,42,95],"Plasma Cell Myeloma","Smoldering Plasma Cell Myeloma","2025-11-28",{"date":98,"type":49},"2025-12-01",{"date":100,"type":49},"2022-06-28",{"date":102,"type":20},"2027-06-28",{"name":104,"class":56},"Roswell Park Cancer Institute",1,{"id":107,"slug":108,"hasResults":11,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":4,"eligibilityCriteria":112,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":113,"targetDuration":4,"studyType":21,"phases":115,"briefSummary":116,"conditions":117,"keywords":4,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":105},"100467158","phase-1-radioimmunotherapy-111indium225actinium-dota-daratumumab-for-the-treatment-of-relapsedrefractory-multiple-myeloma-100467158","NCT05363111","Radioimmunotherapy (111Indium\u002F225Actinium-DOTA-daratumumab) for the Treatment of Relapsed\u002FRefractory Multiple Myeloma","Phase 1 Trial of 111Indium\u002F225Actinium-DOTA-Daratumumab in Patients With Relapsed\u002FRefractory Multiple Myeloma","Inclusion Criteria:\n\n* Documented informed consent of the participant and\u002For legally authorized representative\n\n  * Assent, when appropriate, will be obtained per institutional guidelines\n* Age \\>= 18 years\n* Karnofsky performance status (KPS) \\> 60%\n* Multiple myeloma according to International Myeloma Working Group (IMWG) criteria with measurable disease defined as one of the following:\n\n  * Serum monoclonal protein \\>= 1.0 g\u002FdL (or 0.5 g\u002FdL in patients with immunoglobulin A \\[IgA\\] multiple myeloma \\[MM\\])\n  * 24 hour urine monoclonal protein \\>= 200 mg\u002F24 hour\n  * Serum free light chain (FLC) of \\> 10 mg\u002FdL and an abnormal kappa:lambda ratio\n* Minimum of two prior lines of therapy\n* Previously received treatment with all of the following: a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 monoclonal antibody. Refractory (defined per IMWG Consensus Criteria) to daratumumab\n* CD38 expression on multiple myeloma (MM) cells from bone marrow aspirate or biopsy as demonstrated by flow cytometry or immunohistochemistry\n* Refractory (defined per IMWG Consensus Criteria) or intolerant to most recent therapy\n* Fully recovered from the acute toxic effects (except alopecia) to =\\\u003C grade 1 to prior anti-cancer therapy\n* Prior antitumor therapy must have been completed prior to enrollment as follows:\n\n  * \\>= 21 days for investigational agents, cytotoxic chemotherapy\n  * \\>= 21 days for radiation therapy. Note: Patients must have measurable disease that has been untreated\u002Funaffected by local radiation therapy\n  * \\>= 3 months for prior anti-CD38-targeted therapy, adoptive cell therapy\n  * \\>=14 days for proteasome inhibitor therapy\n  * \\>= 7 days for immunomodulatory agents\n* Absolute neutrophil count (ANC) \\>= 1,000\u002Fmm\\^3 (within 14 days prior to day 1 of protocol therapy)\n\n  * NOTE: Growth factor is not permitted within 7 days of ANC assessment unless cytopenia is secondary to disease involvement\n* Platelets \\>= 75,000\u002Fmm\\^3 (\\>= 50,000\u002Fmm\\^3 if \\>= 50% marrow involvement) (within 14 days prior to day 1 of protocol therapy)\n\n  * NOTE: Platelet transfusions are not permitted within 14 days of platelet assessment unless cytopenia is secondary to disease involvement\n* Total bilirubin =\\\u003C 1.5 x upper limit of normal (ULN) (unless has Gilbert's disease) (within 14 days prior to day 1 of protocol therapy)\n* Aspartate aminotransferase (AST) =\\\u003C 3 x ULN (within 14 days prior to day 1 of protocol therapy)\n* Alanine aminotransferase (ALT) =\\\u003C 3 x ULN (within 14 days prior to day 1 of protocol therapy)\n* Creatinine =\\\u003C 1.5 mg\u002Fdl AND\u002FOR creatinine clearance of \\>= 40 mL\u002Fmin per 24 hour urine test or the Cockcroft-Gault formula (within 14 days prior to day 1 of protocol therapy)\n* Women of childbearing potential (WOCBP): negative urine or serum pregnancy test\n\n  * If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required (within 14 days prior to day 1 of protocol therapy)\n* Woman of childbearing potential must be practicing a highly effective method of birth control consistent with local regulations regarding the use of birth control methods for subjects participating in clinical studies: e.g., established use of oral, injected or implanted hormonal methods of contraception; placement of an intrauterine device or intrauterine system; barrier methods; condom with spermicidal foam\u002Fgel\u002Ffilm\u002Fcream\u002Fsuppository or occlusive cap (diaphragm or cervical\u002Fvault caps) with spermicidal foam\u002Fgel\u002Ffilm\u002Fcream\u002Fsuppository; male partner sterilization; true abstinence (when this is in line with the preferred and usual lifestyle of the subject) during and after the study (6 months after the last dose of 225Ac-DOTA-Daratumumab for women).\n\nA man who is sexually active with a woman of childbearing potential and has not had a vasectomy must agree to use a barrier method of birth control, e.g., either condom with spermicidal foam\u002Fgel\u002Ffilm\u002Fcream\u002Fsuppository or partner with occlusive cap (diaphragm or cervical\u002Fvault caps) with spermicidal foam\u002Fgel\u002Ffilm\u002Fcream\u002Fsuppository, and all men must also not donate sperm during the study and for 6 months after receiving the last dose of study drug\n\n* Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \\> 1 year (women only)\n\nExclusion Criteria:\n\n* Daratumumab or other anti CD38 antibody treatment \\\u003C 3 months prior to study enrollment\n* Prior radiopharmaceutical therapy\n* Detectable antibodies directed against daratumumab\n* Subject has received previous radiation to \\> 25% of their bone marrow\n* Female patients who are lactating or have a positive pregnancy test during the screening period\n* Major surgery within 14 days prior to start of study treatment\n* Subject is receiving concurrent chemotherapy, radiation, or biologic for cancer treatment. Subject is receiving bone marrow stimulatory factors (e.g., granulocyte-macrophage colony-stimulating factor \\[GM-CSF\\]). Note: Hormonal therapy for someone with a history of cancer treated with curative intent is permitted if subject has been on hormonal therapy \\> 1 year\n* Vaccination with live attenuated vaccines within 4 weeks of study agent administration\n* A diagnosis of primary amyloidosis, plasma cell leukemia, Waldenstrom macroglobulinemia, or POEMS\n* Severe persistent asthma (forced expiratory volume in 1 second \\[FEV1\\] \\\u003C 60% and\u002For daily symptoms) or severe chronic obstructive pulmonary disease (COPD) defined clinically or by historical pulmonary function tests with an FEV1 \\\u003C 50% predicted\n* Subject has known allergies, hypersensitivity, or intolerance to monoclonal antibodies or human proteins, or their excipients (refer to respective package inserts or investigator's brochure). Patients with a history of infusion reactions to daratumumab with prior treatment that resolved with supportive measures and in whom daratumumab therapy was not previously discontinued because of infusion reactions are permitted\n* Subject has uncontrolled human immunodeficiency virus (HIV-1), chronic or active hepatitis B, or active hepatitis A or C\n\n  * Patients with HIV are eligible unless their CD4+ T-cell counts are \\\u003C 350 cells\u002FmcL or they have a history of acquired immunodeficiency syndrome (AIDS)-defining opportunistic infection within the 12 months prior to registration. Concurrent treatment with effective antiretroviral therapy (ART) according to Department of Health and Human Services (DHHS) treatment guidelines is recommended\n* Subject has any one of the following:\n\n  * Clinically significant abnormal electrocardiogram (ECG) finding at screening\n  * Congestive heart failure (New York Heart Association class III or IV)\n  * Myocardial infarction within 12 months prior to starting study treatment\n  * Unstable or poorly controlled angina pectoris, including Prinzmetal variant angina pectoris\n* Subject has presence of other active malignancy \\[see exceptions below\\] (However, research participants with history of prior malignancy treated with curative intent and in complete remission are eligible). The following malignancies are exceptions to the active malignancy statement:\n\n  * Basal cell carcinoma of the skin\n  * Squamous cell carcinoma of the skin\n  * Non-muscle invasive bladder cancer\n  * Carcinoma in situ of the cervix\n  * Carcinoma in situ of the breast\n  * Incidental histologic finding of prostate cancer (T1a or T1b using the TNM clinical staging system) or prostate cancer that is curative\n* Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures\n* Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility\u002Flogistics)",{"count":114,"type":20},15,[23],"This phase I trial tests the safety, side effects, and best dose of actinium Ac 225-DOTA-daratumumab (225Ac-DOTA-daratumumab) in combination with daratumumab and indium In 111-DOTA-daratumumab (111In-DOTA-daratumumab) in treating patients with multiple myeloma that does not respond to treatment (refractory) or that has come back (recurrent). Daratumumab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. 111In-DOTA-daratumumab and 225Ac-DOTA-daratumumab are forms of radioimmunotherapy in which a monoclonal antibody, daratumumab, has been linked to a radiotracer to allow for targeted delivery of the treatment to cancer cells. Giving all three together may kill more cancer cells.",[34,42],"2025-10-27",{"date":120,"type":49},"2025-10-29",{"date":122,"type":49},"2022-11-22",{"date":124,"type":20},"2027-03-23",{"name":79,"class":56}]