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

• Status: Recruiting
• Trial end date: 2022-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ohio State University Comprehensive Cancer Center; Srinivas Devarakonda
• Collaborator: National Cancer Institute (NCI)
• Treatments: Cyclophosphamide; Daratumumab; Fludarabine; Fludarabine phosphate; Mechlorethamine; Melphalan; Mycophenolic Acid; Nitrogen Mustard Compounds; Tacrolimus

Criteria

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