Multiple Myeloma Clinical Trial
Official title:
A Phase 3, Intergroup Multicentre, Randomized, Controlled 3 Arm Parallel Group Study to Determine the Efficacy and Safety of Lenalidomide in Combination With Dexamethasone (RD) Versus Melphalan, Prednisone and Lenalidomide (MPR) Versus Cyclophosphamide, Prednisone and Lenalidomide (CPR) in Newly Diagnosed Elderly Multiple Myeloma Subjects
This is a multicenter, randomized, controlled, 3 arm parallel group study designed to evaluate the efficacy and safety of three all-oral combinations: lenalidomide with dexamethasone (Rd) in comparison with lenalidomide in association with MP (MPR) and lenalidomide in association with cyclophosphamide - prednisone (CPR) in newly diagnosed symptomatic MM patients. This protocol also provides a substudy designed to observe asymptomatic patients excluded to the protocol that in any case could be inserted in the study.
This is an intergroup multicenter, randomized, open label study designed to compare the efficacy and safety of Rd with MPR and CPR in newly diagnosed symptomatic MM patients who are 65 years of age or older. Potential study subjects will sign an informed consent prior to undergoing any study related procedure. This study consists of 3 phases for each study subject: Pre-treatment, Treatment and Follow up.Pre-treatment period: patients will undergo screening for protocol eligibility within 28 days (4weeks) prior to randomization. Subjects who meet all the inclusion criteria will be randomized based on a computer-generated randomization schedule prepared by the Coordinating Centre. The first randomization will occur for the induction treatment: Arm A (Rd) or B (MPR) or C (CPR). Within each arm patients will be then randomized for the maintenance treatment(lenalidomide or lenalidomide and prednisone): Arms A1 (R) and A2 (RP); Arms B1 (R) and B2 (RP); Arms C1 (R) and C2 (RP). Randomization will be concealed until the end of the induction period for the maintenance treatment. Patients will be stratified at randomization according to the International Staging System (5) and age (< 75 years vs > 75 years).Treatment period includes induction and maintenance. During the induction and maintenance phases, all patients will attend periodic study center visits in order to asses the safety and efficacy of the treatment. This protocol also provides a substudy designed to observe asymptomatic patients excluded to the protocol that in any case could be inserted in the study . The asymptomatic patient is characterized by the absence of end-organ damage or tissue involvement, such as anemia, bone lesions, hypercalcemia, and renal failure, or by other relevant clinical conditions, such as hyperviscosity, amyloidosis, and recurrent infections (CRAB). ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05027594 -
Ph I Study in Adult Patients With Relapsed or Refractory Multiple Myeloma
|
Phase 1 | |
Completed |
NCT02412878 -
Once-weekly Versus Twice-weekly Carfilzomib in Combination With Dexamethasone in Adults With Relapsed and Refractory Multiple Myeloma
|
Phase 3 | |
Completed |
NCT01947140 -
Pralatrexate + Romidepsin in Relapsed/Refractory Lymphoid Malignancies
|
Phase 1/Phase 2 | |
Recruiting |
NCT05971056 -
Providing Cancer Care Closer to Home for Patients With Multiple Myeloma
|
N/A | |
Recruiting |
NCT05243797 -
Phase 3 Study of Teclistamab in Combination With Lenalidomide and Teclistamab Alone Versus Lenalidomide Alone in Participants With Newly Diagnosed Multiple Myeloma as Maintenance Therapy Following Autologous Stem Cell Transplantation
|
Phase 3 | |
Active, not recruiting |
NCT04555551 -
MCARH109 Chimeric Antigen Receptor (CAR) Modified T Cells for the Treatment of Multiple Myeloma
|
Phase 1 | |
Recruiting |
NCT05618041 -
The Safety and Efficay Investigation of CAR-T Cell Therapy for Patients With Hematological Malignancies
|
N/A | |
Active, not recruiting |
NCT03844048 -
An Extension Study of Venetoclax for Subjects Who Have Completed a Prior Venetoclax Clinical Trial
|
Phase 3 | |
Recruiting |
NCT03412877 -
Administration of Autologous T-Cells Genetically Engineered to Express T-Cell Receptors Reactive Against Neoantigens in People With Metastatic Cancer
|
Phase 2 | |
Completed |
NCT02916979 -
Myeloid-Derived Suppressor Cells and Checkpoint Immune Regulators' Expression in Allogeneic SCT Using FluBuATG
|
Phase 1 | |
Recruiting |
NCT03570983 -
A Trial Comparing Single Agent Melphalan to Carmustine, Etoposide, Cytarabine, and Melphalan (BEAM) as a Preparative Regimen for Patients With Multiple Myeloma Undergoing High Dose Therapy Followed by Autologous Stem Cell Reinfusion
|
Phase 2 | |
Completed |
NCT03665155 -
First-in- Human Imaging of Multiple Myeloma Using 89Zr-DFO-daratumumab, a CD38-targeting Monoclonal Antibody
|
Phase 1/Phase 2 | |
Terminated |
NCT03399448 -
NY-ESO-1-redirected CRISPR (TCRendo and PD1) Edited T Cells (NYCE T Cells)
|
Phase 1 | |
Completed |
NCT02812706 -
Isatuximab Single Agent Study in Japanese Relapsed AND Refractory Multiple Myeloma Patients
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT05024045 -
Study of Oral LOXO-338 in Patients With Advanced Blood Cancers
|
Phase 1 | |
Active, not recruiting |
NCT03989414 -
A Study to Determine the Recommended Dose and Regimen and to Evaluate the Safety and Preliminary Efficacy of CC-92480 in Combination With Standard Treatments in Participants With Relapsed or Refractory Multiple Myeloma (RRMM) and Newly Diagnosed Multiple Myeloma (NDMM)
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT03792763 -
Denosumab for High Risk SMM and SLiM CRAB Positive, Early Myeloma Patients
|
Phase 2 | |
Withdrawn |
NCT03608501 -
A Study of Ixazomib, Thalidomide and Dexamethasone in Newly Diagnosed and Treatment-naive Multiple Myeloma (MM) Participants Non-eligible for Autologous Stem-cell Transplantation
|
Phase 2 | |
Recruiting |
NCT04537442 -
Clinical Study to Evaluate the Safety and Efficacy of IM21 CAR-T Cells in the Treatment of Elderly Patients With Relapsed or Refractory Multiple Myeloma
|
Phase 1 | |
Completed |
NCT02546167 -
CART-BCMA Cells for Multiple Myeloma
|
Phase 1 |