Ended Therapeutic confirmatory (Phase III) Relapsed and/or Refractory Multiple Myeloma

A Phase 3 Study to Evaluate the Efficacy and Safety of Alnuctamab Compared to Standard of Care Regimens in Participants with Relapsed or Refractory Multiple Myeloma (RRMM)

EU CTIS ID: 2023-509472-42-00

What this study is testing

The main goal is to see if alnuctamab can help people live longer without their cancer getting worse, compared to standard treatments.

  • Therapeutic confirmatory (Phase III)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • Participant must be ≥ 18 years of age (or the legal age of consent in the jurisdiction in which the study is taking place) at the time of signing the informed consent form.
  • Participant has a documented diagnosis of MM, and must: -Have received at least 1 but not more than 3 prior lines of anti-myeloma therapy. Note: One line can contain a planned sequence of treatments (eg, induction, [with or without] hematopoietic stem cell transplant, [with or without] consolidation, and/or [with or without] maintenance therapy).
  • Have received prior treatment with lenalidomide and an anti-CD38 monoclonal antibody (for at least 2 consecutive cycles).
  • Have achieved minimal response or better to at least 1 prior anti-myeloma therapy.
  • Have documented PD during or after their last anti-myeloma therapy or failure to achieve response.
  • Participants must have measurable disease (as determined by central laboratory), including at least 1 of the criteria below: - Myeloma (M)-protein quantities ≥ 0.5 g/dL by serum protein electrophoresis. - ≥ 200 mg/24-hour urine collection by urine protein electrophoresis. - Serum free light chain levels > 100 mg/L involved light chain and an abnormal kappa/lambda (κ/λ) ratio in participants without detectable serum or urine M-protein.

You likely can't join if

  • Participant with known current, or history of, central nervous system involvement of multiple myeloma. Evaluation of the cerebrospinal fluid and imaging is only required if central nervous system (CNS) involvement is clinically suspected during the screening process by the investigator.
  • Participant is not eligible for any SOC regimen on the control arm.
  • Participant has received prior BCMA-targeted TCE or BCMA-targeted CAR-T therapy.
  • Participant has never achieved at least stable disease response to prior T-cell redirection therapy (TCE or chimeric antigen receptor T cell [CAR-T])

The study team makes the final eligibility decision.

Where it's taking place

  • Korea, Republic of
  • Argentina
  • Turkey
  • Chile
  • Switzerland
  • United States
  • Canada
  • Australia
  • India
  • China
  • Brazil
  • Japan
  • United Kingdom

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Korea, Republic of; Argentina; Turkey; Chile; Switzerland; United States and 7 more location(s). Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.