CTN-0102 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

Principal Investigator: Michael B. Maris, MD

Protocol Number: RMBMT-144

Major Objectives

Minor Objectives

Patient Selection

Inclusion Criteria:

1. Pts meeting the Durie and Salmon criteria for initial diagnosis of MM.
2. Stage II or III MM at diagnosis or anytime there after.
3. Symptomatic MM requiring treatment at diagnosis or anytime thereafter.
4. 70 years of age or younger at time of first registration.
5. Pts who have received at least 3 cycles of initial systemic therapy and are within 2-10 months of initiation of the initial therapy.
6. Pts receiving chemotherapy-based mobilization regimens must be able to receive high-dose melphalan between 2 and 8 weeks after the initiation of mobilization therapy.
7. Patients with adequate organ function as measured by:
   • Caridac: LVEF at rest > 40%
   • Hepatic: Bilirubin < 2x ULN and ALT and AST < 3x ULN
   • Renal: Creatinine clearance > 40ml/min
   • Pulmonary: DLCO, FEV₁, FVC >50% of predicted value (corrected for hgb)
8. Pts with an adequate auto graft defined as a cryopreserved PBSC graft containing ≥ 4.0 x 10⁶ CD34+ cells/kg pt weight. If prior to enrollment, it is known that a pt will be on the auto-allo arm, the required autograft must contain at least 2.0 x 10⁶ CD34+ cells/kg pt weight.

Exclusion Criteria:

1. Pts that have never advanced beyond Stage I MM since diagnosis.
2. Pts with non-secretory MM (absence of Bence Jones protein in the urine defined by conventional electrophersis and immunofixation techniques)
3. Pts with Plasma cell leukemia
4. Karnofsky performance score of less than 70%
5. Pts with uncontrolled hypertension.
6. Pts with uncontrolled bacterial, viral or fungal infections (currently taking medication and progression of clinical symptoms)
7. Pts with prior malignancies except resected basal cell carcinoma or treated cervical carcinoma in situ. Cancer treated with curative intent > 5years previously will be reviewed on a case-by-case basis by the Medical Monitor.
8. Female pts who are pregnant (positive B-HCG) or breastfeeding.
9. Pts seropositive for the HIV
10. Fertile men or women unwilling to use contraceptive techniques during and for 12 months following treatment.
11. Prior allograft or prior autograft.
12. Pts who have received mid-intensity melphalan (>50mg IV) as part of prior therapy.
13. Pts unable or unwilling to provide informed consent.