Multiple Myeloma (MM)
Conditions
Brief summary
1. Stage 1: Incidence and severity of adverse events, including dose-limiting toxicities (DLTs), with severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0); for cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome(ICANS), severity is determined according to respective American Society for Transplantation and Cellular Therapy (ASTCT) Consensus Grading Scales, 2. Stage 2: ORR, defined as the proportion of patients with a stringent complete response (sCR), CR, very good partial response (VGPR), or partial response (PR), 3. Stage 2: Rate of CR or sCR, defined as proportion of patients achieving a CR or sCR, 4. Stage 2: Rate of VGPR or better, defined as the proportion of patients achieving a VGPR or better, 5. Stage 2: PFS, defined as the time from initiation of study treatment to the first occurrence of progressive disease or death from any cause (whichever occurs first), 6. Stage 2: OS, defined as the time from initiation of study treatment to death from any cause
Detailed description
1. Stage 1 (maintenance substudies): Conversion to a better response (e.g., from PR to VGPR or better; or from VGPR to CR/sCR or from CR to sCR), 2. Stage 1 (maintenance substudies): PFS, defined as the time from initiation of study treatment to the first occurrence of progressive disease or death from any cause (whichever occurs first), 3. Stage 1 (maintenance substudies): OS, defined as the time from initiation of study treatment to death from any cause, 4. Stage 1 (maintenance substudies): MRD negativity rate, defined as proportion of patients who are MRD negative at any time by next-generation sequencing (NGS) on bone marrow aspirate, 5. Stage 1 (all other substudies): ORR, defined as the proportion of patients with a sCR, CR, VGPR, or PR, 6. Stage 1 (all other substudies): Rate of CR or sCR, defined as proportion of patients achieving a CR or sCR, 7. Stage 1 (all other substudies): Rate of VGPR or better, defined as the proportion of patients achieving a VGPR or better, 8. Stage 1 (all other substudies): PFS, defined as the time from initiation of study treatment to the first occurrence of progressive disease or death from any cause (whichever occurs first), 9. CO43271 Stage 1 (all other substudies): DOR, defined as the time from the first documented objective response until disease progression or death from any cause, (whichever occurs first), 10. Stage 1 (all other substudies): OS, defined as the time from initiation of study treatment to death from any cause, 11. Stage 1 (all other substudies): MRD negativity rate, defined as proportion of patients who are MRD negative at any time by NGS on bone marrow aspirate, 12. Stage 1 (all other substudies): Time to first response (for patients who achieve a response of PR or better), defined as time from initiation of study treatment to first achieving a PR or better, 13. Stage 1 (all other substudies): Time to best response (for patients who achieve a response of PR or better), defined as time from initiation of study treatment to achieving the deepest response, 14. Stage 2: DOR, defined as the time from the first documented objective response until disease progression or death from any cause (whichever occurs first), 15. Stage 2: Time to first response (for patients who achieve a response of PR or better), defined as time from initiation of study treatment to achieving a PR or better, 16. Stage 2: Time to best response (for patients who achieve a response of PR or better), defined as time from initiation of study treatment to achieving the deepest response, 17. Stage 2: MRD negativity rate, defined as proportion of patients who are MRD negative by NGS on bone marrow aspirate, 18. Stage 2: Incidence and severity of adverse events, including DLTs, with severity determined according to NCI CTCAE v5.0; for CRS and ICANS, severity is determined according to ASTCT Consensus Grading Scales
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Stage 1: Incidence and severity of adverse events, including dose-limiting toxicities (DLTs), with severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0); for cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome(ICANS), severity is determined according to respective American Society for Transplantation and Cellular Therapy (ASTCT) Consensus Grading Scales, 2. Stage 2: ORR, defined as the proportion of patients with a stringent complete response (sCR), CR, very good partial response (VGPR), or partial response (PR), 3. Stage 2: Rate of CR or sCR, defined as proportion of patients achieving a CR or sCR, 4. Stage 2: Rate of VGPR or better, defined as the proportion of patients achieving a VGPR or better, 5. Stage 2: PFS, defined as the time from initiation of study treatment to the first occurrence of progressive disease or death from any cause (whichever occurs first) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Stage 1 (maintenance substudies): Conversion to a better response (e.g., from PR to VGPR or better; or from VGPR to CR/sCR or from CR to sCR), 2. Stage 1 (maintenance substudies): PFS, defined as the time from initiation of study treatment to the first occurrence of progressive disease or death from any cause (whichever occurs first), 3. Stage 1 (maintenance substudies): OS, defined as the time from initiation of study treatment to death from any cause, 4. Stage 1 (maintenance substudies): MRD negativity rate, defined as proportion of patients who are MRD negative at any time by next-generation sequencing (NGS) on bone marrow aspirate, 5. Stage 1 (all other substudies): ORR, defined as the proportion of patients with a sCR, CR, VGPR, or PR, 6. Stage 1 (all other substudies): Rate of CR or sCR, defined as proportion of patients achieving a CR or sCR, 7. Stage 1 (all other substudies): Rate of VGPR or better, defined as the proportion of patients achieving a VGPR or better, 8. Stage 1 | — |
Countries
France, Germany, Poland, Spain