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| Title: |
A Trial of Tandem Autologous Stem Cell Transplants +/- Post Second Autologous Transplant Maintenance Therapy versus Single Autologous Stem Cell Transplant Followed by Matched Sibling Non-myeloablative Allogeneic Stem Cell Transplant for Patients with Multiple Myeloma |
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| Phase: |
III |
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| Purpose: |
The primary objective is to compare progression-free survival at three years between the two arms. |
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| Eligibility: |
Initial Eligibility Criteria
Must meet the Durie and Salmon criteria for initial diagnosis of MM Patients with Stage II or III MM at time of diagnosis or anytime thereafter Have symptomatic MM requiring treatment at diagnosis or anytime thereafter < 70 years old at the time of enrollment Patient must have received at least 3 cycles of initial systemic therapy and are within 2-10 months of initiation of that initial therapy (this time frame excludes the time for mobilization chemotherapy). Patient with adequate organ function as measured by: Cardiac: LVEF at rest > 40% Hepatic: Bilirubin < 2 x the upper limit of normal and ALT and AST < 3 x the Upper limit of normal Renal: Creatinine clearance > 40 ml/min Pulmonary: DLCO, FEV1, FVC > 50% of predicted value (corrected for hemoglobin)
Patients with an adequate autologous graft defined as a cryopreserved PBSC graft containing > 4.0 x 106 CD34+ cells/kg patient weight. If prior to enrollment, it is known that a patient will be on the auto-allo arm (i.e. a consenting, eligible HLA-matched sibling donor is available), the required autograft must contain at least 2.0 x 106 CD34+ cells/kg patient weight. The graft may not be CD 34+ selected or otherwise manipulated to remove tumor or other cells. The graft can be collected at the transplanting institution or by a referring center. For patients without an HLA-matched sibling donor, the autograft must be stored so that there are two products each containing at least 2 x 106 CD34+ cells/kg.
Initial Exclusion Criteria
Patient that have never advanced beyond Stage I MM since diagnosis Patients with non-secretory MM (absence of Bence Jones protein in the urine defined by use of conventional electrophoresis and immunofixation techniques). Patients with plasma cell leukemia Karnofsky score less than 70% Patients with uncontrolled hypertension Patients with uncontrolled bacterial, viral or fungal infections (currently taking medication and progression of clinical symptoms) Patient with prior malignancies except resected basal cell carcinoma or treated cervical carcinoma in situ. Cancer treated with curative intent >5 years previously will be reviewed on a case-by-case basis by one of the Protocol chairs Female patients who are pregnant or breastfeeding Patients with seropositivity for HIV Fertile men or women unwilling to use contraceptive techniques during and for 12 months following treatment Prior allograft or prior autograft Patients who have received mid-intensity Melphalan (>50mg IV) as part of prior therapy Patients unable or unwilling to provide informed consent
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| Treatment: |
Patient Eligibility Criteria for Second Transplant - In order to be eligible to continue on protocol and receive their second transplant (preferably between 60-120 days, but at least 60 days post-initial transplant) patients must have recovered sufficiently from their first transplant. Conditioning therapy for the second transplant must start at least 60 days post first transplant.
Patient Eligibility Criteria for Tandem Autologous Transplant Patient to Begin Maintenance Therapy - Patients without an HLA-matched sibling donor will be randomized to either observation or one year of maintenance therapy to begin after their second transplant. The randomization assignment will be revealed when the Post-tandem Autologous transplant checklist is completed, at least 60 days post second transplant. Patients without an HLA-matched sibling donor must have recovered sufficiently from their second transplant (preferably between 60-120 days, but at least 60 days post second transplant) in order to initiate Dexamethasone and thalidomide maintenance therapy. Recovery from high-dose Melphalan and autografting will be defined by achievement of the clinical criteria with the exception that patients do not require repeat cardiac or pulmonary testing.
Allograft Donor Eligibility Criteria
6/6 HLA genotypically identical sibling Donor must consent to G-CSF administration and to leukapheresis for PBSC allograft Donor must have adequate veins for leukapheresis or agree to placement of central venous catheter (femoral, subclavian) Age < 75 years at the time patient is initially registered on study
Allograft Donor Exclusion Criteria
Identical twin Age less than 18 years Female patients who are -HCG positive) or breastfeeding/pregnant Infection with HIV, viral hepatitis (B or C) Known allergy to G-CSF Current serious systemic illness Uncontrolled bacterial, viral or fungal infection (currently taking medication and progression of clinical symptoms) Donors receiving experimental therapy or investigational agents Donors with cancer other than treated basal cell or carcinoma in situ of cervix. Cancer treated with curative intent > 5 years previous will be reviewed on a case-by-case basis by one of the Protocol Chairs
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| Contact: |
Phoenix, AZ
City of Hope Samaritan BMT Program
PI – Dr. Jeffrey Schriber
Coordinator: Joan Ralph Webber, RN
602-747-9712 – Fax 602-747-9739
joan.webber@bannerhealth.com
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