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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), 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.

Disqualifiers

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.

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

  • Dexamethasone

    Drug

    Specified dose on specified days

Treatment groups

187 Participants
are divided into 5 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
Group E: Arm E: BMS-986393 + Mezigdomide and DexamethasoneExperimental treatment 3 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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