ClinicalTrials.Veeva

Menu

A Study to Evaluate Efficacy and Safety of Alnuctamab Compared to Standard of Care Regimens in Participants With Relapsed or Refractory Multiple Myeloma (RRMM) (ALUMMINATE)

Celgene logo

Celgene

Status and phase

Withdrawn
Phase 3

Conditions

Multiple Myeloma

Treatments

Drug: Elotuzumab
Drug: Daratumumab
Drug: Pomalidomide
Drug: Dexamethasone
Drug: Alnuctamab
Drug: Carfilzomib

Study type

Interventional

Funder types

Industry

Identifiers

NCT06232707
U1111-1281-8227 (Registry Identifier)
CA058-1019
2023-509472-42 (Registry Identifier)

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy and safety of alnuctamab compared to standard of care regimens in participants with relapsed or refractory multiple myeloma (RRMM).

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

  • Participant is willing and able to adhere to the study visit schedule and other protocol requirements including bone marrow aspirations and/or biopsies and hospitalization during the first cycle.

  • Documented diagnosis of multiple myeloma (MM), and must:.

    i) Received at least 1 but not more than 3 prior lines of anti-myeloma therapy.

ii) Received prior treatment with lenalidomide and an anti-CD38 monoclonal antibody (for at least 2 consecutive cycles).

iii) Achieved minimal response (MR) or better to at least 1 prior anti-myeloma therapy.

iv) Documented PD during or after their last anti-myeloma therapy or failure to achieve response.

  • Must have measurable disease (as determined by central laboratory).
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1, or 2 at the time of the screening.

Exclusion Criteria

  • Active, uncontrolled, or suspected infection.
  • Known current, or history of, central nervous system involvement of multiple myeloma.
  • History or presence of clinically relevant CNS pathology.
  • Received prior BCMA-targeted TCE or BCMA-targeted CAR-T therapy.
  • Previously received allogeneic stem cell transplantation at any time or received autologous stem cell transplantation within 3 months of initiating study intervention.
  • Other protocol-defined Inclusion/Exclusion criteria apply.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

0 participants in 2 patient groups

Arm A: Alnuctamab
Experimental group
Treatment:
Drug: Alnuctamab
Arm B: Standard of Care Regimens
Active Comparator group
Treatment:
Drug: Carfilzomib
Drug: Dexamethasone
Drug: Daratumumab
Drug: Pomalidomide
Drug: Elotuzumab

Trial contacts and locations

172

Loading...

Central trial contact

BMS Study Connect Contact Center www.BMSStudyConnect.com; First line of the email MUST contain NCT # and Site #.

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems