Daratumumab, Pomalidomide, and Dexamethasone in Treating Patients With Relapsed Multiple Myeloma

Part of paid clinical trials in Wichita, Kansas.

Sponsor
Academic and Community Cancer Research United
Study ID
NCT03841565
Phase
PHASE2
Status
Withdrawn

Conditions

  • Recurrent Plasma Cell Myeloma

Eligibility Criteria

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

Interventions

  • Daratumumab — BIOLOGICAL
    Given IV
  • Dexamethasone — DRUG
    Given PO
  • Pomalidomide — DRUG
    Given PO

Study Details

This phase II trial studies how well daratumumab, pomalidomide, and dexamethasone work in treating patients with multiple myeloma that has come back (relapsed). Immunotherapy with daratumumab may induce changes in body's immune system and may interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as pomalidomide and dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving daratumumab with dexamethasone and pomalidomide may work bettering in treating patient compared to dexamethasone and pomalidomide alone.

Key Dates

Start date
Aug 7, 2020
Status verified
Aug 2021
Primary completion
Feb 9, 2022
Completion
Feb 9, 2022

Study Design

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

Arms

  • Experimental: Treatment (pomalidomide, daratumumab, dexamethasone)
    Patients receive pomalidomide PO QD on days 1-21 and daratumumab IV on days 1, 8, 15, and 22 of cycles 1-2, days 1-15 of cycles 3-6, and day 1 of subsequent cycles. Patients also receive dexamethasone PO on days 1, 8, 15, and 22 of cycles 1-12. Cycles every 28 days in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Best overall response rate to the therapy [ Time Frame: Up to 3 years ]

Locations (5)

FacilityCityStateZIPSite coordinators
Cancer Center of Kansas - WichitaWichitaKansas67214-
Mayo Clinic in RochesterRochesterMinnesota55905-
Metro Minnesota Community Oncology Research ConsortiumSaint Louis ParkMinnesota55416-
State University of New York Upstate Medical UniversitySyracuseNew York13210-
McLeod Regional Medical CenterFlorenceSouth Carolina29506-

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