A Phase 3 Randomized, Open-label, Multicenter Study of Isatuximab (SAR650984) in Combination With...
Plasma Cell MyelomaPrimary Objectives: Safety run-in: To confirm the recommended dose of isatuximab when combined with lenalidomide and dexamethasone in participants with high-risk smoldering multiple myeloma (SMM) Randomized Phase 3: To demonstrate the clinical benefit of isatuximab in combination with lenalidomide and dexamethasone in the prolongation of progression-free survival when compared to lenalidomide and dexamethasone in subjects with high-risk SMM Secondary Objectives: Safety run-in To assess overall response rate (ORR) To assess duration of response (DOR) To assess minimal residual disease (MRD) negativity in participants achieving very good partial response (VGPR) or complete response (CR) To assess time to diagnostic (SLiM CRAB) progression or death To assess time to first-line treatment for multiple myeloma (MM) To assess the potential immunogenicity of isatuximab Impact of abnormal cytogenetic subtype on participant outcome Randomized Phase 3 - Key Secondary Objectives: To compare between the arms MRD negativity Sustained MRD negativity Second progression-free survival (PFS2) Overall survival Other Secondary Objectives: To evaluate in both arms CR rate ORR DOR Time to diagnostic (SLiM CRAB) progression Time to biochemical progression Time to first-line treatment for MM Safety and tolerability Pharmacokinetics (PK) Potential of isatuximab immunogenicity Clinical outcome assessments (COAs)
MInimal Residual Disease Adapted Strategy
Multiple MyelomaIFM 2020-02 will enroll patients eligible for ASCT less than 66 years. All patients will receive induction based on 6 cycles (28-day) of KRD-Isatuximab (Isa-KRD), in order to achieve deep responses and high MRD negativity rates. Patients will be classified at diagnosis according to cytogenetics (standard vs high-risk cytogenetics defined by the LP score including 17p deletion, t(4;14), del(1p32), gain 1q, trisomy 21 and trisomy 5).
Study of Belantamab Mafodotin as Pre- and Post-autologous Stem Cell Transplant and Maintenance for...
MyelomaThis is a single-institution, single-arm, phase 2 study in which belantamab mafodotin (GSK2857916), an antibody-drug conjugate targeting B-cell maturation antigen (BCMA), will be administered to patients with multiple myeloma prior to and following high-dose melphalan and autologous stem cell transplantation (ASCT), in conjunction with standard lenalidomide maintenance. We hypothesize that administration of belantamab mafodotin as part of autologous stem cell transplant consolidation and maintenance will be safe, well tolerated, and efficacious in comparison to historical data.
T Cells Expressing a Bispecific CAR Targeting CS1 and BCMA in Relapsed/Refractory Multiple Myeloma...
CS1+ or BCMA+ Multiple MyelomaThis is a single-center, open-label, single-arm study to evaluate the safety and efficacy of the bispecific CAR T cells targeting CS1 and BCMA in patients with relapsed or refractory multiple myeloma.
Anti-BCMA CAR-T Cell Therapy for the R/R Multiple Myeloma
Multiple MyelomaAlthough the anti-CD19 CAR-T cell therapies have gained significant results in patients with relapsed and refractory B-cell hematologic malignancies. There are few effective treatments for MM(multiple myeloma). BCMA (B cell maturation antigen) is a promising target for malignant plasma cells. Therefore, we designed a clinical trial using anti-BCMA CAR-T cell therapy for patients with relapsed and refractory multiple myeloma.
Low-Dose Selinexor and Choline Salicylate for Non-Hodgkin or Hodgkin Lymphoma, Histiocytic/Dendritic...
Recurrent Histiocytic and Dendritic Cell NeoplasmRecurrent Hodgkin Lymphoma6 moreThis phase Ib trial evaluates the side effects and best dose of choline salicylate given together with a low dose of selinexor in treating patients with non-Hodgkin or Hodgkin lymphoma, or multiple myeloma whose prior treatment did not help their cancer (refractory) or for patients with histiocytic/dendritic cell neoplasm. Anti-inflammatory drugs, such as choline salicylate lower the body's immune response and are used with other drugs in the treatment of some types of cancer. Selinexor may stop the growth of cancer cells by blocking a protein called CRM1 that is needed for cell growth. This trial may help doctors learn more about selinexor and choline salicylate as a treatment for with non-Hodgkin or Hodgkin lymphoma, histiocytic/dendritic cell neoplasm, multiple myeloma.
APRIL CAR-T Cell Therapy for Patients With BCMA/TACI Positive Relapsed and/or Refractory Multiple...
Multiple Myeloma in RelapseMultiple Myeloma1 moreA study of APRIL CAR-T cells therapy for patients with BCMA/TACI positive relapsed and/or refractory multiple myeloma
Belantamab Mafadotin Maintenance Therapy After Salvage Autologous Hematopoietic Cell Transplantation...
Multiple MyelomaThe goal of this clinical research study is to learn if belantamab mafodotin (Blenrep) can help to prevent multiple myeloma (MM) from coming back after patients have had an autologous stem cell transplant (AutoSCT). The safety of this drug after transplant will also be studied
A Phase 1/2 Study of a Fully Human BCMA-targeting CAR (CT103A) in Patients With Relapsed/Refractory...
Multiple MyelomaThis study is a single-armed, open-label, multicenter Phase 1/2 study to evaluate the efficacy and safety of CT103A in subjects with relapsed and refractory MM.
Observation of the Efficacy of BAd Regimen in the Treatment of Relapsed and Refractory Multiple...
BendamustineMultiple MyelomaObserve the best dose, efficacy and adverse reactions of BAd in the treatment of relapsed and refractory multiple myeloma.