Brief Summary:
The purpose of this study is to compare the efficacy, safety, and tolerability of ide-cel
with lenalidomide (LEN) maintenance to that of LEN maintenance alone in adult
participants with Newly Diagnosed Multiple Myeloma (NDMM) who have achieved a suboptimal
response post autologous stem cell transplantation (ASCT).
Inclusion Criteria
- Participants aged ≥18 with Newly Diagnosed Multiple Myeloma (NDMM) who has received
induction therapy followed by high-dose chemotherapy and autologous stem cell
transplantation (ASCT), without subsequent consolidation or maintenance. EXCEPTION:
Participant received ≤ 7 days of lenalidomide (LEN) maintenance therapy and the
investigator documents that there is no impact to the overall benefit/risk
assessment due to the temporary interruption of LEN.
- Participant must have received 4 to 6 cycles of induction therapy, which must
contain at a minimum an immunomodulatory drugs (IMiD) and a proteasome inhibitor
(PI) (with or without anti-CD38 monoclonal antibody) and must have had a single ASCT
80 to 120 days prior to consent. Note: Participant must not have confirmed
progression since commencing induction.
- Participant must have documented response of PR or VGPR at time of consent.
- Participant must have Eastern Cooperative Oncology Group (ECOG) performance status ≤
1 (participants with ECOG 2 due to pain because of underlying myeloma-associated
bone lesions are eligible per investigator's discretion).
- Participant must have recovered to ≤ Grade 1 for any nonhematologic toxicities due
to prior treatments, excluding alopecia and Grade 2 neuropathy.
Exclusion Criteria
- Participant with known central nervous system involvement with myeloma.
- Participant has non-secretory MM.
- Participant has systemic and uncontrolled fungal, bacterial, viral, or other
infection.
- Participant has history of primary immunodeficiency.
- Participant has previous history of an allogeneic hematopoietic stem cell
transplantation or treatment with any gene therapy-based therapeutic for cancer or
investigational cellular therapy for cancer or B-cell maturation antigen targeted
therapy.
- Other protocol-defined Inclusion/Exclusion criteria apply.
Primary outcome:
1. Progression Free Survival (PFS) (Time Frame - Up to approximately 49 months after the first participant is randomized):
PFS as assessed by Independent Review Committee (IRC)
Secondary outcome:
1. Overall Survival (OS) (Time Frame - Up to approximately 60 months after the last participant is randomized)
2. Percentage of Participants with Sustained Minimal Residual Disease Negative (MRDneg) Complete Response (CR) for 12 months (Time Frame - From randomization up to 27 months from randomization)
3. Percentage of Participants with Minimal Residual Disease Negative (MRDneg) Complete Response (CR) (Time Frame - From randomization up to 15 months from randomization)
4. Event-Free Survival (EFS) (Time Frame - Up to approximately 60 months after the last participant is randomized)
5. Duration of Response (DOR) (Time Frame - Up to approximately 60 months after the last participant is randomized)
6. Percentage of Participants with Complete Response (CR) (Time Frame - Up to approximately 60 months after the last participant is randomized):
CR as assessed by IRC
7. Time to Progression (TTP) (Time Frame - Up to approximately 60 months after the last participant is randomized):
Progression as assessed by IRC
8. Progression post-next line of treatment (PFS2) (Time Frame - Up to approximately 60 months after the last participant is randomized)
9. Time to Next Treatment (TTNT) (Time Frame - Up to approximately 60 months after the last participant is randomized)
10. Number of Participants Experiencing Adverse Events (AEs) (Time Frame - Up to approximately 60 months after the last participant is randomized)
11. Number of Participants Experiencing Adverse Events of Special Interest (AESI) (Time Frame - Up to approximately 60 months after the last participant is randomized)
12. Maximum Observed Plasma Concentration (Cmax) (Time Frame - Up to approximately 60 months after the last participant is randomized)
13. Time of Maximum Observed Plasma Concentration (Tmax) (Time Frame - Up to approximately 60 months after the last participant is randomized)
14. Area Under the Curve (AUC) from time zero to 28 days post infusion (AUC [0- 28D]) (Time Frame - Up to 28 days post infusion)
15. Time of Last Measurable Observed Plasma Concentration (Tlast) (Time Frame - Up to approximately 60 months after the last participant is randomized)
16. Time-to-Definitive Deterioration (Time Frame - Up to approximately 49 months after the first participant is randomized):
Time-to-definitive deterioration based on the European Organization for Research and
Treatment of Cancer core quality of life questionnaire EORTC QLQ-C30 global health
status/quality of life subscale
17. Mean Change from Baseline in EORTC QLQ-C30 Selected Subscales (Time Frame - Up to approximately 49 months after the first participant is randomized):
The following subscales on the European Organization for Research and Treatment of Cancer
core quality of life questionnaire EORTC QLQ-C30 will be assessed:
- Global health status/quality of life
- Physical Functioning
- Fatigue
- Pain
18. Mean Change from Baseline in EORTC QLQ-MY20 Selected Subscales (Time Frame - Up to approximately 49 months after the first participant is randomized):
The following subscales on the European Organization for Research and Treatment of Cancer
core quality of life questionnaire EORTC QLQ-MY20 will be assessed:
- Disease symptoms
- Side-effects of treatment
- Experimental: Arm A
- Active Comparator: Arm B
- idecabtagene vicleucel (BMS-986395 / Abecma / bb2121 / ide-cel / ):
Specified dose on specified days - Lenalidomide (Revlimid / LEN / ):
Specified dose on specified days - Fludarabine (FLUDARA / BENDARBIN / ):
Specified dose on specified days - Cyclophosphamide (ENDOXAN / CYTOXAN / ):
Specified dose on specified days
Quelle: ClinicalTrials.gov
