Reduce Intensity Conditioning Donor Stem Cell Transplant for the Treatment of Relapsed Multiple Myeloma
Condition: Recurrent Plasma Cell Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Intervention: Allogeneic Hematopoietic Stem Cell Transplantation; Cyclophosphamide; Daratumumab; Fludarabine; Melphalan; Mycophenolate Mofetil; Tacrolimus
Intervention description: Undergo allogeneic hematopoietic stem cell transplantation; Given IV; Given IV; Given IV; Given IV; Given IV or PO; Given PO or IV
Intervention MeSH terms: Mycophenolic Acid; Cyclophosphamide; Melphalan; Mechlorethamine; Nitrogen Mustard Compounds; Fludarabine; Daratumumab; Tacrolimus
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

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.
    

Eligibility 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