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

Phase 1RecruitingNCT06121843

Juno Therapeutics, Inc., a Bristol-Myers Squibb Company147 enrolled

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).

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

147

Conditions

Multiple Myeloma

Interventions

BMS-986393DRUG

Specified dose on specified days

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * History of relapsed and/or refractory multiple myeloma (RRMM) treated with at least 3 (Part 1) or at least 1 but not greater than 3 prior anti-myeloma treatment regimens (Part 2). * Measurable multiple myeloma (MM) as per International Myeloma Working Group (IMWG). * Eastern Cooperative Oncology Group performance status of 0-1. Exclusion Criteria: * Prior treatment with alnuctamab (Arm A), mezigdomide (Arm B), iberdomide (Arm C), elranatamab (Arm D) or BCMA-targeting therapy (Part 2 Arms A and D). * Prior treatment with GPRC5D-targeting therapies. * Other protocol-defined inclusion/exclusion criteria apply.

Locations (19)

University of Alabama at Birmingham

Birmingham, Alabama, United States

RECRUITING

Mayo Clinic in Arizona - Phoenix

Phoenix, Arizona, United States

RECRUITING

City of Hope Comprehensive Cancer Center

Duarte, California, United States

RECRUITING

Mayo Clinic in Florida

Jacksonville, Florida, United States

RECRUITING

Northside Hospital

Atlanta, Georgia, United States

RECRUITING

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

RECRUITING

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

RECRUITING

Mayo Clinic in Rochester, Minnesota

Rochester, Minnesota, United States

RECRUITING

University Of Nebraska Medical Center

Omaha, Nebraska, United States

RECRUITING

John Theurer Cancer Center at Hackensack University Medical Center

Hackensack, New Jersey, United States

RECRUITING

...and 9 more locations

Outcomes

Primary Outcomes

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 Outcomes

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

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

Overview

Conditions

Interventions

Eligibility

Locations (19)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts