Study of Combination POM, BTZ, Low-Dose DEX, and DARA (PVD-DARA) in Patients With RRMM

Sponsor
Alliance Foundation Trials, LLC.
Study ID
NCT05408026
Phase
PHASE1/PHASE2
Status
Withdrawn

Conditions

  • Relapsed or Refractory Multiple Myeloma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Daratumumab — DRUG
    Daratumumab (and hyaluronidase) will be given over 3-5 minutes subcutaneously (under the skin) in the clinic at alternating left/right abdominal sites. Patient will take dexamethasone orally (by mouth) either before coming to clinic or in clinic, before other medications. Only for the first cycle, patient will receive on Day 1 daratumumab (which is mixed with a compound called hyaluronidase) and dexamethasone, 1 day before patient start the other 2 medications.
  • Pomalidomide — DRUG
    On day 2 of cycle 1, patient will start the other medications and will therefore receive bortezomib administered subcutaneously (SC) over 3-5 minutes and dexamethasone given orally (by mouth), either before coming to clinic or in clinic, before bortezomib. Patient will also start pomalidomide on the same day, which patient will take that evening at home and every evening for 21 days.

Study Details

This phase II clinical trial design with a safety run-in period will be used to assess the rate of VGPR or better for the combination PVD-Dara in the treatment of RRMM.

Key Dates

Start date
Oct 1, 2022
Status verified
Jan 2023
Primary completion
Oct 1, 2025
Completion
Feb 28, 2026

Study Design

Enrollment
0 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Combination of Pomalidomide, Bortezomib, Low-Dose Dexamethasone, and Daratumumab
    Combination of Pomalidomide, Bortezomib, Low-Dose Dexamethasone, and Daratumumab

Primary Outcome Measure

Safety Run-In Stage: Adverse events (AEs) will be assigned a grade and attribution using CTCAE v5.0 to determine the presence of dose-limiting toxicities (DLT). [ Time Frame: 4-9 months ]

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