NIPH Clinical Trials Search

Newly Diagnosed Multiple Myeloma: Etentamig+D vs. DRd in Subjects with NDMM Not Eligible for Transplant

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Multiple Myeloma
Date of first enrollment	03/12/2025
Target sample size	68
Countries of recruitment	France,Japan,Spain,Japan,Norway,Japan,US,Japan
Study type	Interventional
Intervention(s)	Experimental: Phase 2: Etentamig + Daratumumab Dose A Participants will receive etentamig dose A in combination with daratumumab until the recommended phase 3 dose (RP3D), as part of the approximately 16 year study duration. Experimental: Phase 2: Etentamig + Daratumumab Dose B Participants will receive etentamig dose B in combination with daratumumab until the RP3D, as part of the approximately 16 year study duration. Experimental: Phase 2: Etentamig + Daratumumab Dose C Participants will receive etentamig dose C in combination with daratumumab until the RP3D, as part of the approximately 16 year study duration. Experimental: Phase 3: Etentamig + Daratumumab RP3D Participants will receive etentamig at the RP3D in combination with daratumumab, as part of the approximately 16 year study duration. Experimental: Phase 3: Daratumumab, Lenalidomide, and Dexamethasone (DRd) Participants will receive DRd, as part of the approximately 16 year study duration.

Outcome(s)

Primary Outcome

Phase 2 and 3: Percentage of Participants with Adverse Events (AE)s Phase 2: Change in Clinical Activity Phase 3: Minimal Residual Disease (MRD) Negative CR Rate Phase 3: Progression-Free Survival (PFS)

Secondary Outcome

Phase 2: MRD Negative CR Rate Phase 2: PFS Phase 2: Sustained MRD Negativity Rate Phase 2: Area Under the Serum Concentration-Time Curve (AUC) Phase 2: Overall Survival (OS) Phase 2: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability Phase 2: Maximum Observed Serum Concentration (Cmax) Phase 2: Time to Cmax (Time to Maximum Observed Concentration, Tmax) Phase 2: Positive Anti-Drug Antibodies (ADAs) Phase 2: Negative ADAs Phase 2: Neutralizing Anti-Drug Antibodies (NAbs) Phase 3: OS Phase 3: Sustained MRD Negativity Rate Phase 3: Rate of >= CR Phase 3: Rate of >= VGPR or Better Phase 3: ORR Phase 3: Time to Response (TTR) Phase 3: Duration of Response (DOR) Phase 3: Time-to-Progression (TTP) Phase 3: Event Free Survival (EFS) Phase 3: Progression-Free Survival on Subsequent Therapy (PFS2) Phase 3: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability Phase 3: Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Physical Functioning Score Phase 3: Change from Baseline in EORTC QLQ-C30 Global Health Status/QoL Score Phase 3: Change from Baseline and Time to Deterioration in the Remaining Scales and Items of EORTC QLQ-C30 Phase 3: Symptomatic AEs as Assessed by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Phase 3: Overall Bother Due to Treatment Side Effects as Assessed by the Functional Assessment of Cancer Therapy-General (FACT-G) GP5 Phase 3: Change from Baseline in Patient Global Impression of Severity (PGIS) Scores Phase 3: Change from Baseline in European Quality of Life 5 Dimensions (EQ-5D-5L) Scores

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	Not applicable
Gender	Both
Include criteria	- Participants must have confirmed new diagnosis of multiple myeloma (NDMM) according to the International Myeloma Working Group (IMWG) diagnostic criteria, and per investigator's judgement, participant is not suitable to receive high-dose chemotherapy and stem cell transplantation due to factors likely to have a negative impact on tolerability of high dose chemotherapy and autologous stem cell transplants (ASCT). - IMWG Myeloma Frailty Index Score of >= 1 - All participants must have measurable disease per central laboratory with at least 1 of the following assessed within 28 days prior to enrollment: - Serum M-protein >= 0.5 g/dL (>= 5 g/L). - Urine M-protein >= 200 mg/24 hours. - Serum free light chain (FLC) >= 100 mg/L (>= 10 mg/dL) (involved light chain) and an abnormal serum kappa lambda ratio only for participants without measurable serum or urine M-protein.
Exclude criteria	- Prior or current systemic therapy or stem cell transplant (SCT) for multiple myeloma or any plasma cell dyscrasia other than short course of corticosteroids - Participant treated with any investigational treatment within 30 days or 5 half-lives of the treatment (whichever is longer) prior to the first dose of study treatment or is currently enrolled in another clinical study - Participant who has known active central nervous system involvement of MM. - Participant who has history of clinically significant renal, neurologic, psychiatric, endocrine, metabolic, immunologic, pulmonary, or hepatic disease within the last 6 months that, in the investigator's opinion, would adversely affect the participant's participation in the study.