Health Trials

A Study to Compare the Efficacy and Safety of BMS-986393 Versus Standard Regimens in Adult Participants With Relapsed or Refractory and Lenalidomide-exposed Multiple Myeloma (QUINTESSENTIAL-2)

ConditionRelapsed or Refractory Multiple Myeloma (RRMM)
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorJuno Therapeutics, Inc., a Bristol-Myers Squibb Company

About this trial

The purpose of this study is to compare the efficacy and safety of arlo-cel (BMS-986393) versus standard regimens in adult participants with Relapsed or Refractory and Lenalidomide-exposed Multiple Myeloma.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participants must have relapsed or refractory multiple myeloma (RRMM).

Participants must have received at least 1 but no greater than 3 prior multiple myeloma (MM) regimens which may include a proteasome inhibitor (PI), an immunomodulatory drug (IMiD), and an anti-CD38 monoclonal antibody and have prior exposure to lenalidomide.

Participants must have a documented diagnosis of MM as per International Myeloma Working Group Criteria.

Participants must have measurable disease during screening.

Disqualifiers

Participants must not have known active or history of central nervous system (CNS) involvement of Multiple Myeloma (MM).

Participants must not have solitary plasmacytomas or non-secretory myeloma without other evidence of measurable disease.

Participants must not need urgent treatment due to rapidly progressing MM.

Other protocol-defined Inclusion/Exclusion criteria apply.

Trial design

Design model

Parallel

Treatments tested in this trial

  • BMS-986393

    Drug

    Specified dose on specified days

  • Cyclophosphamide

    Drug

    Specified dose on specified days

  • Fludarabine

    Drug

    Specified dose on specified days

  • Daratumumab

    Drug

    Specified dose on specified days

  • Pomalidomide

    Drug

    Specified dose on specified days

  • Dexamethasone

    Drug

    Specified dose on specified days

  • Carfilzomib

    Drug

    Specified dose on specified days

Treatment groups

440 Participants
are divided into 2 treatment groups
Group A: Arm AExperimental treatment 7 interventions
Group B: Arm BActive comparator 4 interventions

Trial outcomes

Primary outcomes

1

Progression Free Survival (PFS)

Time frame
Up to 5 years after the last participant is randomized
2

Minimal residual disease (MRD)-negativity in complete response (CR)

Time frame
Up to 1 year after the last participant is randomized

Secondary outcomes

1

Overall survival (OS)

Time frame
Up to 5 years after the last participant is randomized
2

Overall response rate (ORR)

Time frame
Up to 5 years after the last participant is randomized
3

Minimal residual disease (MRD)-negative status

Time frame
Up to 5 years after the last participant is randomized
4

Complete response rate (CRR)

Time frame
Up to 5 years after the last participant is randomized

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

Celgene Corporation

Collaborator

Source ClinicalTrials.gov
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