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NCT Number: NCT06121843

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

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).

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Arthur J.E. Child Comprehensive Cancer Centre, Calgary, Alberta, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BMS-986393

Drug

Specified dose on specified days

Other names: CC-95266, Arlocabtagene autoleucel, arlo-cel

Alnuctamab

Drug

Specified dose on specified days

Other names: BMS-986349, CC-93269, EM901

mezigdomide

Drug

Specified dose on specified days

Other names: BMS-986348, CC-92480

Iberdomide

Drug

Specified dose on specified days

Other names: BMS-986382, CC-220

Elranatamab

Drug

Specified dose on specified days

Other names: Elrexfio

Dexamethasone

Drug

Specified dose on specified days

Other names: Decadron

Primary outcomes

  1. Incidence of adverse events (AEs)

    Time frame: Up to 2 years

  2. Incidence of serious adverse events (SAEs)

    Time frame: Up to 2 years

  3. Incidence of adverse events of special interest (AESI)

    Time frame: Up to 2 years

  4. Incidence of AEs leading to discontinuation

    Time frame: Up to 2 years

  5. Number of Deaths

    Time frame: Up to 2 years

  6. Establish recommended Phase 2 dose (RP2D)

    Time frame: Up to 2 years

Secondary outcomes

  1. Overall response rate (ORR)

    Time frame: Up to 2 years

  2. Complete response rate (CRR)

    Time frame: Up to 2 years

  3. Very good partial response rate (VGPRR)

    Time frame: Up to 2 years

  4. Maximum observed concentration (Cmax) of arlocabtagene autoleucel

    Time frame: Up to 2 years

  5. Time of maximum observed concentration (tmax) of arlocabtagene autoleucel

    Time frame: Up to 2 years

  6. Area under the concentration-time curve from time 0 to 28 days [AUC (0-28D)] of arlocabtagene autoleucel

    Time frame: Up to 2 years

Study contacts

Contact information is provided by the study sponsor or research team.

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

[email protected]

855-907-3286

First line of the email MUST contain NCT # and Site #.

CONTACT

Sponsors and collaborators

Lead sponsor

Juno Therapeutics, Inc., a Bristol-Myers Squibb Company

Industry

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Nov 8, 2023
Registry last updated
Jul 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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