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KarMMa-3 (BB2121-MM-003)

AcronymISRCTNEudraCTClinicaltrials.govDRKS
BB2121-MM-0032018-001023-38NCT03651128

A Phase 3, Multicenter, Randomized, Open-label Study to Compare the Efficacy and Safety of bb2121 Versus Standard Triplet Regimens in Subjects with Relapsed and Refractory Multiple Myeloma (RRMM)

Status: Active

Purpose / Objectives

Primary Outcome

  • The primary objective of the study is to compare the efficacy of bb2121 to standard triplet regimens in subjects with relapsed and refractory multiple myeloma (RRMM) as measured by progression-free survival (PFS)

Secondary Outcomes

  • Evaluate the safety of bb2121 compared to standard triplet regimens in subjects with RRMM

  • Evaluate additional efficacy parameters of bb2121 compared to standard triplet regimens in subjects with RRMM including overall survival (OS)

  • Characterize the expansion and persistence of chimeric antigen receptor (CAR) + T cells, in the peripheral blood by vector copy number (VCN) in subjects treated with bb2121

  • Evaluate the percentage of subjects who attain minimal residual disease (MRD) negative status by EuroFlow and next generation sequencing (NGS)

  • Evaluate the impact of bb2121 compared to standard triplet regimens on the changes in health-related quality of life (HRQoL)

  • Evaluate the impact of bb2121 on health utility values compared with standard triplet regimens

 

Diagnosis

Patient attributes

Age

18-99

Inclusion criteria

  • Subject has received at least 2 prior MM regimens.
  • Subject has received prior treatment with a proteasome inhibitor- and an
    immunomodulatory compound-containing regimen for at least 2 consecutive cycles.
  • Refractory is defined as documented progressive disease during or within 60 days (measured from the last dose of any drug within the regimen) of completing treatment with the last anti-myeloma regimen before study entry.
  • Subject achieved a response (minimal response [MR] or better) to at least 1 prior treatment regimen.
  • Subject has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Recovery to Grade 1 or baseline of any non-hematologic toxicities due to prior treatments, excluding alopecia and Grade 2 peripheral neuropathy.
  • Adequate vascular access for leukapheresis
  • [...]

Exclusion criteria

  • Subject has nonsecretory MM.
  • Subject has any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study.
  • Subject has active or history of plasma cell leukemia, Waldenstrom’s macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes) or amyloidosis.
  • Subject with known central nervous system (CNS) involvement with myeloma.
  • Subject has clinical evidence of pulmonary leukostasis and disseminated intravascular coagulation.
  • [...]

Trial design

  • Phase III
  • Multicenter
  • Prospective
  • Randomized
  • Two-arm
  • Parallel
  • Open Label

Intervention

  • For Treatment Arm A, the treatment period will start with LD chemotherapy on Day -5, followed by bb2121 infusion on Day 1 of Month 1 (+7 day window).
  • For Treatment Arm B, the treatment period will start with DARA +POM +dex or DARA + BTZ + dex or IXA + LEN + dex administration on Day 1 of Month 1.

Documents (password protected)

Responsibilities in overall trial

Celgene Corporation

    Study Sites

    Klinik I für Innere Medizin

    Study office

    • Klinisches Studienzentrum der Klinik I für Innere Medizin Köln

    Status

    Active

    Principal Investigator

    Prof. Dr. med. Dr. h. c. Christoph Scheid

    Deputy of Principal Investigator

    • PD Dr. med. Marco Herling
    • PD Dr. Dr. med. Udo Holtick

    Contact at Site