Reduce Intensity Conditioning Donor Stem Cell Transplant for the Treatment of Relapsed Multiple Myeloma

Part of paid clinical trials in Columbus, Ohio.

Sponsor
Srinivas Devarakonda
Study ID
NCT04205240
Phase
PHASE2
Status
Terminated

Conditions

  • Recurrent Plasma Cell Myeloma

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Allogeneic Hematopoietic Stem Cell Transplantation — PROCEDURE
    Undergo allogeneic hematopoietic stem cell transplantation
  • Cyclophosphamide — DRUG
    Given IV
  • Daratumumab — BIOLOGICAL
    Given IV
  • Fludarabine — DRUG
    Given IV
  • Melphalan — DRUG
    Given IV
  • Mycophenolate Mofetil — DRUG
    Given IV or PO
  • Tacrolimus — DRUG
    Given PO or IV

Study Details

This phase II trial studies how well a reduced intensity conditioning regimen after donor stem cell transplant works in treating patients with multiple myeloma that has come back (relapsed). Drugs used in chemotherapy, such as cyclophosphamide, tacrolimus, and mycophenolate mofetil, 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. Immunotherapy with monoclonal antibodies, such as daratumumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving a reduce intensity conditioning regimen consisting of cyclophosphamide, tacrolimus, mycophenolate mofetil, and daratumumab after donor stem cell transplant may improve survival and reduce the risk of multiple myeloma coming back.

Key Dates

Start date
Dec 22, 2020
Status verified
Sep 2023
Primary completion
May 8, 2021
Completion
Nov 22, 2021

Study Design

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

Arms

  • Experimental: Treatment (conditioning regimen, stem cell transplant)
    Patients receive fludarabine IV on days -5 to -2 and melphalan IV on days -3 to -2, then undergo stem cell transplantation on day 0. Patients receive cyclophosphamide on days 3 and 4, tacrolimus PO BID or IV starting on day 5, and mycophenolate mofetil IV or PO TID on days 5 to 35. Patients also receive daratumumab IV starting between days 90-150 for up to 1 year. Treatment continues in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

2-year Progression-free Survival (PFS) [ Time Frame: From the date of transplant until the date of relapse or date of death from any cause, assessed at 2 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
Ohio State University Comprehensive Cancer CenterColumbusOhio43210-

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By research site
Ohio State University Comprehensive Cancer Center· Columbus, OH

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