NCT05408026

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

A Phase II, Multicenter, Open-Label Study of the Combination of Pomalidomide, Bortezomib, Low-Dose Dexamethasone, and Daratumumab in Patients With Relapsed or Refractory Multiple Myeloma

• Status: Withdrawn
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Alliance Foundation Trials, LLC. · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

A phase II clinical trial design, including an initial safety run-In period, will be used to assess the rate of VGPR or better for the combination PVD-Dara in the treatment of relapsed or refractory multiple myeloma. In the run-in period, a maximum of 12 patients will be enrolled onto the trial using the initially proposed regimen and then the trial will be temporarily closed to enrollment, until safety data is reviewed for these patients. Adverse events during the first cycle of treatment of the initially proposed regimen will be closely monitored. If the safety criteria have been met as defined in the protocol, then the trial will reopen to enrollment using the regimen as planned until a total of 72 patients have been enrolled. If safety criteria have not been met as per protocol, then the treatment regimen will be modified for the second cohort of 12 patients after discussion with the study team taking into consideration that if intolerability is due to neutropenia the regimen will be modified by lowering the dose of pomalidomide. The phase II will begin once the safe doses have been determined in the Run-in period. this Phase II clinical trial was designed to assess whether this 4-agent combination yields a response rate of VGPR or better in more than 65% of patients. For the regimen found tolerable in the safety period, a two-stage Phase II clinical trial design was chosen to assess whether the VGPR or better response rate is at most 50% against the alternative that the VGPR or better response rate is at least 65%.

Conditions

• Relapsed or Refractory Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Daratumumab	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.
DRUG	Pomalidomide	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.

Timeline

• Start date: 2022-10-01
• Primary completion: 2025-10-01
• Completion: 2026-02-01
• First posted: 2022-06-07
• Last updated: 2023-01-27

Regulatory

• FDA-regulated drug study