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

NCT05408026 · Status: WITHDRAWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL

Last updated 2023-01-27

No results posted yet for this study

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.

Conditions

Interventions

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.

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.

Sponsors & Collaborators

  • Janssen, LP

    collaborator INDUSTRY

  • Celgene

    collaborator INDUSTRY

  • Alliance Foundation Trials, LLC.

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-01
Primary Completion
2025-10-01
Completion
2026-02-28
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05408026 on ClinicalTrials.gov