Clinical Studies for Myeloma

Title: Phase I study of vaccination with DC/MM fusion cells in combination with BCMA directed CAR-T cell therapy in relapsed/refractory multiple myeloma
Brief Title: DC/MM Fusion Vaccine With BCMA CAR-T in R/R MM
Brief Summary: This study is to evaluate the safety and effectiveness of dendritic cell DC/MM fusion vaccine in combination with standard of care B-cell maturation antigen (BCMA) CAR-T cell therapy in participants with relapsed/refractory multiple myeloma. The names of the study drugs involved in this study are: - DC/MM fusion vaccine (a type of personalized cancer vaccine) - Granulocyte-macrophage colony-stimulating factor (GM-CSF) (a type of growth factor or hormone)
For info regarding 25-799 please contact Cancer Clinical Trials at 617-975-7403 or cancerclinicaltrialsinfo@bidmc.harvard.edu
 
Title: A Phase 2, single-arm, open-label study evaluating subcutaneous isatuximab, administered by an on-body delivery system, in combination with weekly carfilzomib and dexamethasone in adult patients with relapsed and/or refractory multiple myeloma (RRMM)
Brief Title: A Study to Investigate Subcutaneous Isatuximab in Combination With Weekly Carfilzomib and Dexamethasone in Adult Participants With Relapsed and/or Refractory Multiple Myeloma
Brief Summary: The primary purpose of this study is to assess the efficacy (overall response rate) of subcutaneous (SC) via on body delivery system (SC-OBDS) isatuximab in combination with weekly carfilzomib and dexamethasone (Kd) in adult participants with RRMM having received 1 to 3 prior lines of therapy.
For info regarding 25-461 please contact Cancer Clinical Trials at 617-975-7403 or cancerclinicaltrialsinfo@bidmc.harvard.edu
 
Title: A PHASE 3, OPEN-LABEL STUDY OF ELRANATAMAB MONOTHERAPY VERSUS ELOTUZUMAB, POMALIDOMIDE, DEXAMETHASONE (EPd) OR POMALIDOMIDE, BORTEZOMIB, DEXAMETHASONE (PVd) OR CARFILZOMIB, DEXAMETHASONE (Kd) IN PARTICIPANTS WITH RELAPSED/REFRACTORY MULTIPLE MYELOMA WHO RECEIVED PRIOR ANTI-CD38 DIRECTED THERAPY
Brief Title: MagnetisMM-32: A Study to Learn About the Study Medicine Called Elranatamab in People With Multiple Myeloma (MM) That Has Come Back After Taking Other Treatments (Including Prior Treatment With an Anti-CD38 Antibody and Lenalidomide)
Brief Summary: The purpose of this study is to learn about the study medicine called elranatamab.This study aims to compare elranatamab to other medicines for the treatment of MM (a type of cancer). This study is seeking participants who: - Are 18 years of age or older and have MM. - Have received treatments before for MM. - Have MM that has returned or not responded to their most recent treatment. Half of the participants will receive elranatamab. The other half of participants will receive a combination therapy selected by the study doctor. The selected combination therapy will include 2 to 3 different medicines commonly used to treat MM. Elranatamab will be given as a shot under the skin at the study clinic about once a week. This may change to a smaller number of shots later in the study. The medicines in the combination therapy will be taken by mouth (at home or at the study clinic) AND will be given either as: - a shot under the skin at the study clinic - through a needle in the vein at the study clinic The number of times these medicines will be taken depends on what combination therapy the study doctor selects. Participants may continue to receive elranatamab or a combination therapy until their MM is no longer responding. The study team will see how each participant is doing with the study treatment during regular visits at the study clinic. The study team will continue to follow-up with participants after study treatment with telephone contacts (or visits). The study will compare the experiences of people receiving elranatamab to those people receiving a combination therapy. This will help learn about the safety and how effective elranatamab is.
For info regarding 25-051 please contact Cancer Clinical Trials at 617-975-7403 or cancerclinicaltrialsinfo@bidmc.harvard.edu
 
Title: A phase 2 study of elranatamab in combination with isatuximab (ELISA) in relapsed and refractory multiple myeloma
Brief Title: ELISA in Relapsed/Refractory MM
Brief Summary: This is an open-label phase 2 study of elranatamab in combination with isatuximab administered subcutaneously in patients with relapsed and refractory multiple myeloma (RRMM) who have received at least two prior lines of therapy and who have had previous treatment with both immunomodulatory drugs (IMiDs) and a proteasome inhibitor (PI). The subcutaneous injection method of isatuximab administration, including the device used to administer isatuximab, is investigational.
For info regarding 24-727 please contact Cancer Clinical Trials at 617-975-7403 or cancerclinicaltrialsinfo@bidmc.harvard.edu
 
Title: Relapsed or Refractory Multiple Myeloma: Etentamig vs Standard Available Therapies in Subjects with RRMM (3L+ RRMM Monotherapy Study)
Brief Title: Study Assessing Activity of Intravenous (IV) Etentamig Monotherapy Versus Standard Available Therapies in Adult Participants With Relapsed or Refractory Multiple Myeloma
Brief Summary: Multiple myeloma (MM) is a cancer of the blood's plasma cells. The cancer is typically found in the bones and bone marrow (the spongy tissue inside of the bones) and can cause bone pain, fractures, infections, weaker bones, and kidney failure. Treatments are available, but MM can come back (relapsed) or may not get better (refractory) with treatment. This is a study to determine change in disease symptoms of etentamig compared to standard available therapies in adult participants with relapsed/refractory (R/R) MM. Etentamig is an investigational drug being developed for the treatment of R/R MM. This study is broken into 2 Arms; Arm A and Arm B. In Arm A, participants will receive etentamig as a monotherapy. In Arm B, participants will receive the standard available therapy (SAT) identified by the Investigator during screening, in accordance with the local (or applicable) approved label, package insert, summary of product characteristics, and/or the institutional guidelines, as applicable. Around 380 adult participants with relapsed/refractory multiple myeloma will be enrolled at approximately 140 sites across the world. In Arm A participants will receive etentamig as an infusion into the vein in 28 day cycles, during the 3.5 year study duration. In Arm B, participants will receive the SAT identified by the Investigator during screening, in accordance with the local (or applicable) approved label, package insert, summary of product characteristics, and/or the institutional guidelines, as applicable, during the 3.5 year study duration. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and questionnaires.
For info regarding 24-711 please contact Cancer Clinical Trials at 617-975-7403 or cancerclinicaltrialsinfo@bidmc.harvard.edu
 
Title: MMRC HORIZON ONE: A PHASE II RANDOMIZED ADAPTIVE PLATFORM TRIAL EVALUATING NOVEL THERAPIES IN RELAPSED OR REFRACTORY MULTIPLE MYELOMA
Brief Title: MMRC Horizon One Adaptive Platform Trial Evaluating Therapies in RRMM
Brief Summary: This trial is an adaptive platform trial. The structure of the protocol allows the trial to evolve over time. Multiple investigational arms will be included within the trial under a Master Protocol (MP). These investigational arms may be added as appendices at different times depending on whether they are trial-ready and whether accrual in the trial will support another arm. Accrual to an arm will terminate in accord with the arm's appendix to the Master Protocol. The purpose of this proposed structure is to support the recurrent research challenge of efficiently evaluating what is the best therapy for a particular patient.
For info regarding 24-476 please contact Cancer Clinical Trials at 617-975-7403 or cancerclinicaltrialsinfo@bidmc.harvard.edu
 
Title: A Phase 1 Study of vaccination with dendritic cell (DC)/multiple myeloma (MM) fusions in combination with Elranatamab in relapsed or refractory multiple myeloma.
Brief Title: A Phase 1 Study of Vaccination With Dendritic Cell (DC)/Multiple Myeloma (MM) Fusions in Combination With Elranatamab in Relapsed or Refractory Multiple Myeloma
Brief Summary: This research is being done to determine if the combination of the Dendritic Cell (DC)/ Multiple Myeloma (MM) fusion vaccine with elranatamab is safe and effective in treating Relapsed or Refractory Multiple Myeloma (MM). The names of the study drugs and vaccine involved in this study are: - DC/MM fusion vaccine (a personalized cancer vaccine in which harvested participant tumor cells are fused with harvested participant dendritic blood cells) - Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) (a type of growth factor) - Elranatamab (a type of T-cell engager antibody)
For info regarding 24-439 please contact Cancer Clinical Trials at 617-975-7403 or cancerclinicaltrialsinfo@bidmc.harvard.edu
 
Title: Phase II study of belantamab mafodotin in combination with carfilzomib, pomalidomide, and dexamethasone (KPd) in patients with relapsed multiple myeloma
Brief Title: Study of Belantamab Mafodotin With Carfilzomib, Pomalidomide, and Dexamethasone in Relapsed Multiple Myeloma
Brief Summary: Doctors leading this study hope to learn if the combination of belantamab mafodotin, carfilzomib, pomalidomide, and dexamethasone is effective and safe when given to people who have multiple myeloma that has gotten worse and is not responding to standard drugs that are used for treating multiple myeloma, including chimeric antigen receptor T-cell therapy. Participation in this research will last about 6 -24 months, but it may be less or more depending on your response to treatment.
For info regarding 24-199 please contact Cancer Clinical Trials at 617-975-7403 or cancerclinicaltrialsinfo@bidmc.harvard.edu
 
Title: A Phase 1, Multicenter, Open-label Study to Evaluate the Safety and Preliminary Efficacy of BMS-986393 in Novel Combinations in Participants with Relapsed and/or Refractory Multiple Myeloma and Determine the Recommended Dose for Each Add-on Investigational Component (Phase I GPRC5D Combo)
Brief Title: A Study to Evaluate the Safety, Effectiveness and Tolerable Dose of Arlocabtagene Autoleucel (BMS-986393) in Novel Combinations in Participants With Relapsed and/or Refractory Multiple Myeloma
Brief Summary: The purpose of this study is to establish a safe and tolerable dose of arlocabtagene autoleucel (BMS-986393) in combinations with alnuctamab, mezigdomide, iberdomide, and elranatamab in participants with relapsed and/or refractory multiple myeloma (RRMM).
For info regarding 23-696 please contact Cancer Clinical Trials at 617-975-7403 or cancerclinicaltrialsinfo@bidmc.harvard.edu
 
Title: Long-Term Follow-Up of Patients Exposed to Lentiviral-Based CAR T-Cell Therapy (CCTL019A2205B)
Brief Title: Novartis LTFU (PAVO)
For info regarding 23-523 please contact Cancer Clinical Trials at 617-975-7403 or cancerclinicaltrialsinfo@bidmc.harvard.edu
 
Title: A phase 2 study of elranatamab as consolidation after idecabtagene vicleucel in relapsed refractory multiple myeloma
Brief Title: Elranatamab in R/R Multiple Myeloma
Brief Summary: This research is being done to see if the study drug, elranatamab, reduces the risk of disease progression (worsening disease) after idecabtagene vicleucel in relapsed refractory multiple myeloma.
For info regarding 23-402 please contact Cancer Clinical Trials at 617-975-7403 or cancerclinicaltrialsinfo@bidmc.harvard.edu
 
Title: Phase II Multicenter Trial of anti-B Cell Maturation Antigen Chimeric Antigen Receptor T Cell Therapy for Multiple Myeloma Patients with Sub-Optimal Response After Autologous Hematopoietic Cell Transplantation and Maintenance Lenalidomide
Brief Title: Upfront Chimeric Antigen Receptor T-Cell to Upgrade Response in Multiple Myeloma
Brief Summary: This study is designed as a Phase II, multicenter, single arm trial to assess anti-B Cell Maturation Antigen (BCMA) chimeric antigen receptor (CAR) T-cells (bb2121) to improve post autologous hematopoietic cell transplant (HCT) responses among patients with multiple myeloma (MM).
For info regarding 21-673 please contact Cancer Clinical Trials at 617-975-7403 or cancerclinicaltrialsinfo@bidmc.harvard.edu
 
Title: A Phase II study evaluating loncastuximab tesirine in patients with previously treated Waldenström Macroglobulinemia
Brief Title: Loncastuximab Tesirine in WM
Brief Summary: This study is being done to examine the safety and effectiveness of loncastuximab tesirine as a possible treatment for participants with Waldenström Macroglobulinemia (WM). The name of the study drug involved in this study is: - Loncastuximab tesirine
For info regarding 21-622 please contact Cancer Clinical Trials at 617-975-7403 or cancerclinicaltrialsinfo@bidmc.harvard.edu
 
Title: Master Protocol for the Phase 1 Study of Cell Therapies for the Treatment of Patients with Relapsed and Refractory Multiple Myeloma, including Long-term Safety Follow-up
Brief Title: Study of Anitocabtagene-autoleucel in Participants With Relapsed Refractory Multiple Myeloma
Brief Summary: Master protocol for cell therapy, Phase 1 proof-of-concept studies in relapsed and refractory multiple myeloma and includes long-term safety follow-up.
For info regarding 19-253 please contact Cancer Clinical Trials at 617-975-7403 or cancerclinicaltrialsinfo@bidmc.harvard.edu
 
Title: A Phase 1, Open-label Study to Evaluate the Safety, Pharmacokinetics, Immunogenicity, and Preliminary Efficacy of MEDI2228 in Subjects with Relapsed/Refractory Multiple Myeloma
Brief Title: MEDI2228 in Subjects With Relapsed/Refractory Multiple Myeloma
Brief Summary: The purpose of this study is to assess the safety, pharmacokinetics and tolerability, describe the dose-limiting toxicities (DLTs), and determine the maximum tolerated dose (MTD) or maximum administered dose (MAD [in the absence of establishing the MTD]) for single agent MEDI2228 in adult subjects with multiple myeloma who are either transplant ineligible or post autologous stem cell transplant and are relapsed/refractory.
For info regarding 18-165 please contact Cancer Clinical Trials at 617-975-7403 or cancerclinicaltrialsinfo@bidmc.harvard.edu
 
Title: Pilot Study of Morbidity at the Time of Initial Diagnosis of Multiple Myeloma with Respect to Race and Health Care System Utilization
Brief Title: Pilot Study of Morbidity at Diagnosis in Myeloma
For info regarding 12-117 please contact Cancer Clinical Trials at 617-975-7403 or cancerclinicaltrialsinfo@bidmc.harvard.edu