Multiple Myeloma Clinical Trial
Reduced Intensity (RIC) Conditioning And Transplantation of HLA-Haplo-HCT
Summary
This is a single institution phase II study of a reduced intensity conditioning (RIC) followed by a haploidentical hematopoietic cell transplant (haplo-HCT) in persons with diagnosis of hematologic malignancy. Conditioning will consists of fludarabine, cyclophosphamide, melphalan and total body irradiation (TBI) preparative regimen with a melphalan dose reduction for patients ≥55 years old and those with HCT Comorbidity Index (CI) >3. This study uses a two-stage phase II design with accrual goal of 84 patients, using 28 patients separately for arms A, C and D
Eligibility Criteria
Inclusion Criteria:
Karnofsky performance status of ≥70% or Lansky play score ≥ 70%
A related haploidentical bone marrow donor with up to 2 or 3 HLA locus-mismatches
The donor and recipient must be HLA identical for at least one haplotype (using high resolution DNA based typing) at the following genetic loci: HLA-A, HLA-B, HLA-C, and HLA-DRB1.
Adequate liver and renal function
Absence of decompensated congestive heart failure, or uncontrolled arrhythmia and left ventricular ejection fraction ≥ 40%
Diffusion capacity corrected (DLCOcorr) > 40% predicted, and absence of O2 requirements
> 6 months after prior autologous transplant (if applicable)
Agrees to use contraception during study treatment
Voluntary written consent (adult or parent/guardian with presentation of the minor information sheet, if appropriate)
Patients who are HIV+ must have undetectable viral load. All HIV+ patients must be evaluated by Infectious Disease (ID) and a HIV management plan establish prior to transplantation
Exclusion Criteria:
< 70 years with an available 5-6/6 HLA-A, B, DRB1 matched sibling donor
Pregnancy or breastfeeding
Current active and uncontrolled serious infection
Acute leukemia in morphologic relapse/persistent disease defined as > 5% blasts in normocellular bone marrow OR any % blasts if blasts have unique morphologic markers (e.g. Auer rods).
CML in blast crisis
Large cell lymphoma, mantle cell lymphoma and Hodgkin disease that is progressive on salvage therapy.
stable non-bulky disease is acceptable.
Active central nervous system malignancy
Criteria For Donor Selection:
Donors must be HLA-haploidentical relatives of the patient, defined as having a shared HLA haplotype between donor and patient at HLA-A, -B, -C, and -DRB1.
Eligible donors (14-70 years old) include biological children, siblings or half siblings, or parents, able and willing to undergo bone marrow harvesting.
For donors <18 years, the maximum recipient weight (actual body weight) should not exceed 1.25 times the donor weight (actual body weight)1 In addition, bone marrow product volume should be limited to 20 ml/kg donor weight for donors <18 years.
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There is 1 Location for this study
Minneapolis Minnesota, 55455, United States
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