A Study to Evaluate the Safety, Effectiveness and Tolerable Dose of Arlocabtagene Autoleucel (BMS-986393) in Novel Combinations in Participants With Relapsed and/or Refractory Multiple Myeloma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: BMS-986393, Alnuctamab, Mezigdomide, Iberdomide.
- Who it may be relevant to
- Registry conditions: Multiple Myeloma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase 1, Multicenter, Open-label Study to Evaluate the Safety and Preliminary Efficacy of Arlocabtagene Autoleucel (BMS-986393) in Novel Combinations in Participants With Relapsed and/or Refractory Multiple Myeloma and Determine the Recommended Dose for Each Add-on Investigational Component
Overview
The purpose of this study is to establish a safe and tolerable dose of arlocabtagene autoleucel (BMS-986393) in combinations with alnuctamab, mezigdomide, iberdomide, and elranatamab in participants with relapsed and/or refractory multiple myeloma (RRMM).
Interventions
- Drug BMS-986393
Specified dose on specified days - Drug Alnuctamab
Specified dose on specified days - Drug Mezigdomide
Specified dose on specified days - Drug Iberdomide
Specified dose on specified days - Drug Elranatamab
Specified dose on specified days - Drug Dexamethasone
Specified dose on specified days
Primary outcome measures
- Incidence of adverse events (AEs) [Time frame: Up to 2 years]
- Incidence of serious adverse events (SAEs) [Time frame: Up to 2 years]
- Incidence of adverse events of special interest (AESI) [Time frame: Up to 2 years]
- Incidence of AEs leading to discontinuation [Time frame: Up to 2 years]
- Number of Deaths [Time frame: Up to 2 years]
- Establish recommended Phase 2 dose (RP2D) [Time frame: Up to 2 years]
Secondary outcome measures (6)
- Overall response rate (ORR) [Time frame: Up to 2 years]
- Complete response rate (CRR) [Time frame: Up to 2 years]
- Very good partial response rate (VGPRR) [Time frame: Up to 2 years]
- Maximum observed concentration (Cmax) of arlocabtagene autoleucel [Time frame: Up to 2 years]
- Time of maximum observed concentration (tmax) of arlocabtagene autoleucel [Time frame: Up to 2 years]
- Area under the concentration-time curve from time 0 to 28 days [AUC (0-28D)] of arlocabtagene autoleucel [Time frame: Up to 2 years]
Eligibility criteria
Inclusion criteria
- History of relapsed and/or refractory multiple myeloma (RRMM) treated with at least 3 (Part 1), history of RRMM or at least 1 but not greater than 3 prior anti-myeloma treatment (PAMT) regimens (Part 2, Arms A, B, C, and D); history of quadruple class exposed RRMM having received BCMA TCE as the most recent line of therapy (Part 2, Arm E).
- Measurable multiple myeloma (MM) as per International Myeloma Working Group (IMWG).
- Eastern Cooperative Oncology Group performance status of 0-1.
- Adherence to contraception requirements.
Exclusion criteria
- Prior treatment with alnuctamab (Arm A), mezigdomide (Arms B and E), iberdomide (Arm C), elranatamab (Arm D) or BCMA-targeting therapy (Part 2 Arms A and D).
- Prior treatment with GPRC5D-targeting therapies as of Protocol Amendment 02 (Part 1 and Part 2).
- Other protocol-defined inclusion/exclusion criteria apply.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 17 centers
- University of Alabama at Birmingham — Birmingham
- Mayo Clinic in Arizona - Phoenix — Phoenix
- City of Hope Comprehensive Cancer Center — Duarte
- Mayo Clinic in Florida — Jacksonville
- Northside Hospital — Atlanta
- Beth Israel Deaconess Medical Center — Boston
- Dana-Farber Cancer Institute — Boston
- Mayo Clinic in Rochester, Minnesota — Rochester
- … and 9 more centers
Canada · 2 centers
- Arthur J.E. Child Comprehensive Cancer Centre — Calgary
- Princess Margaret Cancer Centre — Toronto
Identifiers
NCT: NCT06121843 · CA088-1005