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

What's the purpose of this trial?

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.

This trial is currently open and accepting patients.

What will happen during the trial?

You may be able to join this trial if you:

The following criteria is a partial list of reasons why patients may be eligible to participate in this clinical trial. Further evaluation with a medical professional is required.

Inclusion Criteria:

  • Patients with a partial response (PR) or better prior to allo-transplantation
  • Relapsed MM with chemo sensitivity disease, with or without prior autologous HSCT
  • First allogenic transplant
  • Donors can be haploidentical, mismatch or matched related or unrelated. Stem cell source will be peripheral blood except for haploidentical where stem cell source will be bone marrow
  • Ejection fraction >= 45%
  • Estimated creatinine clearance greater than 40 mL/minute
  • Diffusion capacity of the lung for carbon monoxide (DLCO) >= 40% (adjusted for hemoglobin)
  • Forced expiratory volume in 1 second (FEV1) >= 50%
  • Total bilirubin < 2 x the upper limit of normal
  • Alanine aminotransferase (ALT)/aspartate aminotransferase (AST) < 2.5 x the upper normal limit
  • Signed informed consent

Exclusion Criteria:

  • Patients with polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin change (POEMS), Waldenstrom macroglobulinemia
  • Uncontrolled bacterial, viral or fungal infection
  • Patients with prior malignancies < 3 years except resected basal cell/squamous cell carcinoma, treated carcinoma in-situ. Other cancers treated with curative intent < 3 years previously will not be allowed unless approved by the principal investigator
  • Female patients who are pregnant or breastfeeding. A negative pregnancy test will be required for all women of child bearing potential

Additional Trial Information

Phase 2

Enrollment: 20 patients (estimated)

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Trial Locations

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Ohio

The Ohio State University Comprehensive Cancer Center The James Cancer Hospital and Solove Research Institute

Columbus, OH

Open and Accepting
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