Relapsed or Refractory Multiple Myeloma Clinical Trial
Official title:
A Phase 3 Randomized Study Comparing Teclistamab Monotherapy Versus Pomalidomide, Bortezomib, Dexamethasone (PVd) or Carfilzomib, Dexamethasone (Kd) in Participants With Relapsed or Refractory Multiple Myeloma Who Have Received 1 to 3 Prior Lines of Therapy, Including an Anti-CD38 Monoclonal Antibody and Lenalidomide
The purpose of this study is to compare the efficacy of teclistamab with PVd/Kd.
Multiple myeloma is an incurable, malignant, plasma cell disorder. Teclistamab (JNJ-64007957) is a full-size, Immunoglobulin G (IgG) 4 proline, alanine, and alanine (PAA) bispecific antibody that targets the cluster of differentiation (CD3) receptor expressed on the surface of T cells and B cell maturation antigen (BCMA). With its dual binding sites, teclistamab is able to draw CD3 positive T cells in close proximity to BCMA positive cells, resulting in T-cell activation and subsequent lysis of BCMA positive cells. Pomalidomide is a third-generation immunomodulatory imide drug (IMiD) that exerts potent, direct tumoricidal and immune-enhancing effects and Carfilzomib is a second-generation proteasome inhibitor that inhibits proteasome which results in disruption of protein turnover and induces apoptosis. The primary hypothesis of this study is that teclistamab monotherapy (Arm A) will significantly improve progression free survival (PFS) compared with investigator's choice of PVd or Kd (Arm B) in participants with relapsed or refractory multiple myeloma who have received 1 to 3 prior lines of therapy, including an anti-CD38 monoclonal antibody and lenalidomide. The study will include a screening phase, treatment phase, and follow-up phase. Safety will be assessed by physical examinations, neurologic examinations, eastern cooperative oncology group (ECOG) performance status, clinical laboratory tests, vital signs, and AE monitoring. The overall duration of the study will be up to 9 years. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
NCT03837509 -
INCB001158 Combined With Subcutaneous (SC) Daratumumab, Compared to Daratumumab SC, in Relapsed or Refractory Multiple Myeloma
|
Phase 1/Phase 2 | |
| Recruiting |
NCT05519085 -
A Study to Evaluate Mezigdomide, Bortezomib and Dexamethasone (MEZIVd) Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) in Participants With Relapsed or Refractory Multiple Myeloma (RRMM)
|
Phase 3 | |
| Active, not recruiting |
NCT02099539 -
QUILT-3.005: A Study of ALT-803 in Patients With Relapsed or Refractory Multiple Myeloma
|
Phase 1 | |
| Completed |
NCT00545519 -
A Phase I Study Of Thymoglobulin In Patients With Relapsed Or Refractory Multiple Myeloma
|
Phase 1 | |
| Recruiting |
NCT05052970 -
Mitoxantrone Hydrochloride Liposome Injection, Bortezomib and Dexamethasone in the Treatment of R/R MM
|
Phase 1 | |
| Completed |
NCT03464916 -
Study to Evaluate the Safety and Efficacy of Anti-CD38 CAR-T in Relapsed or Refractory Multiple Myeloma Patients
|
Phase 1 | |
| Recruiting |
NCT05455320 -
A Study Comparing Talquetamab in Combination With Daratumumab or in Combination With Daratumumab and Pomalidomide Versus Daratumumab in Combination With Pomalidomide and Dexamethasone in Participants With Multiple Myeloma That Returns After Treatment or is Resistant to Treatment
|
Phase 3 | |
| Withdrawn |
NCT05408026 -
Study of Combination POM, BTZ, Low-Dose DEX, and DARA (PVD-DARA) in Patients With RRMM
|
Phase 1/Phase 2 | |
| Active, not recruiting |
NCT04684108 -
SG301 Safety Study in Subjects With Relapsed or Refractory Multiple Myeloma and Other Hematological Malignancies
|
Phase 1 | |
| Recruiting |
NCT05652335 -
A Study of JNJ-79635322 in Participants With Relapsed or Refractory Multiple Myeloma or Previously Treated Amyloid Light-chain (AL) Amyloidosis
|
Phase 1 | |
| Completed |
NCT03859427 -
A Study Comparing Once-weekly vs Twice-weekly Carfilzomib in Combination With Lenalidomide and Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma
|
Phase 3 | |
| Completed |
NCT01866293 -
Cabozantinib (XL184) in Patients With Relapsed or Refractory Myeloma
|
Phase 1/Phase 2 | |
| Recruiting |
NCT06375044 -
Study of SIM0500 Alone in Participants With Relapsed or Refractory Multiple Myeloma
|
Phase 1 | |
| Completed |
NCT01058434 -
Safety and Efficacy of TKI258 in Relapsed or Refractory Multiple Myeloma Patients, Who Are With or Without t(4;14) Chromosomal Translocation
|
Phase 2 | |
| Recruiting |
NCT04735575 -
A Ph1/2 Study of EMB-06 in Participants With Relapsed or Refractory Myeloma
|
Phase 1/Phase 2 | |
| Not yet recruiting |
NCT06298266 -
To Assess Safety, Tolerability, and Efficacy of Anti-GPRC5D-CD19-CAR-T in Relapsed/Refractory Multiple Myeloma
|
Early Phase 1 | |
| Active, not recruiting |
NCT04798586 -
MAGNETISMM-2: Study of Elranatamab (PF-06863135) in Japanese Participants With Multiple Myeloma
|
Phase 1 | |
| Terminated |
NCT02075021 -
Phase I/II Trial of the Combination of Lenalidomide (Revlimid) and Nab-paclitaxel (Abraxane) in the Treatment of Relapsed/Refractory Multiple Myeloma
|
Phase 1/Phase 2 | |
| Completed |
NCT00478777 -
A Multicenter, Single-Arm, Open-Label Expanded Access Program for Lenalidomide Plus Dexamethasone in Previously Treated Subjects With Multiple Myeloma
|
Phase 3 | |
| Completed |
NCT06082596 -
Study of BEBT-908 in Subjects With Advanced Hematological Tumors
|
Phase 1 |