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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

ConditionMultiple Myeloma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorJuno Therapeutics, Inc., a Bristol-Myers Squibb Company

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Sequential

Treatments tested in this trial

  • BMS-986393

    Drug

    Specified dose on specified days

  • Alnuctamab

    Drug

    Specified dose on specified days

  • Mezigdomide

    Drug

    Specified dose on specified days

  • Iberdomide

    Drug

    Specified dose on specified days

  • Elranatamab

    Drug

    Specified dose on specified days

Treatment groups

147 Participants
are divided into 4 treatment groups
Group A: Arm A: BMS-986393 + AlnuctamabExperimental treatment 2 interventions
Group B: Arm B: BMS-986393 + MezigdomideExperimental treatment 2 interventions
Group C: Arm C: BMS-986393 + IberdomideExperimental treatment 2 interventions
Group D: Arm D: BMS-986393 + ElranatamabExperimental treatment 2 interventions

Trial outcomes

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

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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

Lead sponsor

Source ClinicalTrials.gov
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