A Phase 3 Randomized Study Comparing the Study Medication in Combination with Daratumumab SC and Pomalidomide (Tal-DP) or the Study Medication in Combination with Daratumumab SC (Tal-D) Versus Daratumumab SC, Pomalidomide and Dexamethasone (DPd), in Participants with Relapsed or Refractory Multiple Myeloma who have Received at Least 1 Prior Line of Therapy

UVA Tracking #
HSR230148
Principal Investigator
Laahn H Foster
Contact
Contact Phone
Official Trial Title
A Phase 3 Randomized Study Comparing Talquetamab SC in Combination With
Daratumumab SC and Pomalidomide (Tal-DP) or Talquetamab SC in Combination With Daratumumab SC (Tal-D) Versus Daratumumab SC, Pomalidomide and Dexamethasone (DPd), in Participants Wit
Study Description

The University of Virginia is conducting a clinical research study for adults ages 18 and over who have relapsed or Refractory Multiple Myeloma. The purpose of this study is to see how the study medication in combination with daratumumab and pomalidomide (Tal-DP) or the study medication and daratumumab (Tal-D) compares to daratumumab, pomalidomide, and dexamethasone (DPd) in treating patients with multiple myeloma, who have not responded to previous treatment. There are three treatment arms in this study. You will randomly, or by chance, be put into one of the treatment arms:
• Treatment Arm A: you will receive the study medication, daratumumab and pomalidomide also known as (Tal-DP)
• Treatment Arm B: you will receive daratumumab, pomalidomide and dexamethasone also known as (DPd)
• Treatment Arm C: you will receive the study medication and daratumumab (Tal-D)

The study will consist of cycles. Each study cycle will be 28 days. You will receive the study drug at different doses and frequencies based on the treatment arm you are assigned to. You will come into the clinic to receive the study treatment.

The study is expected to last for approximately 5 years. The duration of your participation will depend on how you respond to study treatment. The study medication and daratumumab will be administered by an injection under the skin. Dexamethasone will be taken orally or via an IV infusion. Pomalidomide will be taken orally.

Study-required procedures that are being done beyond your standard of care will be provided at no cost to you.

Additional information can be found here: https://clinicaltrials.gov/ct2/show/NCT05455320

Compensation

You may receive compensation or reimbursement for participating in this study.