Clinical trial NCT06121843: A Study to Evaluate the Safety, Effectiveness and Tolerable Dose of BMS-986393 in Novel Combinations in Participants With Relapsed and/or Refractory Multiple Myeloma
Official title: A Phase 1, Multicenter, Open-label Study to Evaluate the Safety and Preliminary Efficacy of 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Multiple Myeloma
Keywords: BMS-986393
Relapsed Multiple Myeloma
Refractory Multiple Myeloma
First-in-human
Alnuctamab
Mezigdomide
Iberdomide
CC-95266
GPRC5D
GPRC5D CAR T
Cell Therapy
CAR T cell therapy
Combination therapy
Lead sponsor: Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
Sponsor class: INDUSTRY
First posted: 2023-11-08
Enrollment: 111
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to establish a safe and tolerable dose of BMS-986393 in combinations with alnuctamab, mezigdomide, and iberdomide in participants with relapsed and/or refractory multiple myeloma (RRMM).


Eligibility criteria: Inclusion Criteria:

* History of relapsed and/or refractory multiple myeloma (RRMM) treated with at least 3 (Part 1 and Part 2) or at least 1 but not greater than 3 prior anti-myeloma treatment regimens (Part 2)
* Measurable multiple myeloma (MM)
* Eastern Cooperative Oncology Group performance status of 0-1

Exclusion Criteria:

* Condition that confounds the ability to interpret data from the study
* Known active or history of central nervous system (CNS) involvement of MM

Note: Other protocol-defined inclusion/exclusion criteria apply

Primary outcomes:
measure: Incidence of adverse events (AEs)
timeFrame: Up to 2 years
measure: Incidence of serious adverse events (SAEs)
timeFrame: Up to 2 years
measure: Incidence of adverse events of special interest (AESI)
timeFrame: Up to 2 years
measure: Incidence of AEs leading to discontinuation
timeFrame: Up to 2 years
measure: Number of Deaths
timeFrame: Up to 2 years
measure: Establish recommended Phase 2 dose (RP2D)
timeFrame: Up to 2 years
Secondary outcomes:
measure: Overall response rate (ORR)
timeFrame: Up to 2 years
measure: Complete response rate (CRR)
timeFrame: Up to 2 years
measure: Very good partial response rate (VGPRR)
timeFrame: Up to 2 years
measure: Maximum observed concentration (Cmax)
timeFrame: Up to 2 years
measure: Time of maximum observed concentration (tmax)
timeFrame: Up to 2 years
measure: Area under the concentration-time curve from time 0 to 28 days [AUC (0-28D)]
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Phoenix
country: United States
facility: Mayo Clinic in Arizona - Phoenix
state: Arizona
city: Duarte
country: United States
facility: City of Hope Comprehensive Cancer Center
state: California
city: Jacksonville
country: United States
facility: Mayo Clinic in Florida
state: Florida
city: Atlanta
country: United States
facility: Northside Hospital
state: Georgia
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: Rochester
country: United States
facility: Mayo Clinic in Rochester, Minnesota
state: Minnesota
city: Omaha
country: United States
facility: University Of Nebraska Medical Center
state: Nebraska
city: Hackensack
country: United States
facility: John Theurer Cancer Center at Hackensack University Medical Center
state: New Jersey
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
city: New York
country: United States
facility: Laura and Isaac Perlmutter Cancer Center
state: New York
city: New York
country: United States
facility: Columbia University Irving Medical Center
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Pittsburgh
country: United States
facility: Local Institution - 0023
state: Pennsylvania
city: Nashville
country: United States
facility: Local Institution - 0025
state: Tennessee
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
city: Calgary
country: Canada
facility: Tom Baker Cancer Center
state: Alberta
city: Toronto
country: Canada
facility: Local Institution - 0024
state: Ontario
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: