Janssen 64407564MMY3009: MonumenTAL-6

What is the Purpose of this Study?

We are doing this study to find out if the drugs talquetamab and teclistamab are a safe and effective option for people with multiple myeloma that has come back after treatment (relapsed) or is not improving with treatment (refractory).

What is the Condition Being Studied?

Relapsed or Refractory Multiple Myeloma

Who Can Participate in the Study?

Adults ages 18+ who are diagnosed with relapsed or refractory multiple myeloma.

For more information about who can join this study, please contact the study team at quinna.marshburn@duke.edu.

Age Group
Adults

What is Involved?

The study is divided into three periods: screening period, study dosing period, and a safety follow-up period.

If you choose to join this study, during the screening period you will:

  • Have a tumor biopsy
  • Have imaging scans (CT, MRI, and echocardiogram)
  • Have physical exams and blood draws

If we find that you are eligible during the screening period, you will proceed to the dosing period. During this period, you will get a random assignment (fair, equal chance) to 1 of 3 study arms:

  • Arm A: If you are in this arm, you will get a regimen of both talquetamab and pomalidomide (Tal-P).
  • Arm B: If you are in this arm, you will get a regimen of both talquetamab and teclistamab (Tal-Tec).
  • Arm C: If you are in this arm, you will get a regimen of elotuzumab, pomalidomide, and dexamethasone (EPd) or pomalidomide, bortezomib, and dexamethasone (PVd).

After you finish your assigned study regimen, we will schedule you to return to our clinic for follow-up visits to keep track of your health and how you are feeling.

Study Details

Full Title
A Phase 3 Randomized Study Comparing Talquetamab in Combination with Pomalidomide (Tal-P), Talquetamab in Combination with Teclistamab (Tal-Tec), and Investigator?s Choice of Either Elotuzumab, Pomalidomide, and Dexamethasone (EPd) or Pomalidomide, Bortezomib, and Dexamethasone (PVd) in Participants with Relapsed or Refractory Myeloma who Have Received 1 to 4 Prior Lines of Therapy Including an Anti-CD38 Antibody and Lenalidomide
Principal Investigator
Professor of Medicine
Protocol Number
IRB: PRO00116532
NCT: NCT06208150
Phase
Phase III
ClinicalTrials.gov
Enrollment Status
NEW