Clinical trial NCT00075829 (phase 3, status: completed)
Conditions: multiple myeloma
ICD codes: C90.01, C90.02, C90.00
Drugs: thalidomide, dexamethasone
SMILES: CC(C)NCC(O)COC1=CC=CC2=C1C=CC=C2, C[C@@H](O[C@H]1OCCN(CC2=NNC(=O)N2)[C@H]1C1=CC=C(F)C=C1)C1=CC(=CC(=C1)C(F)(F)F)C(F)(F)F
Eligibility criteria:

        Inclusion Criteria:

          -  Meeting the Durie and Salmon criteria for initial diagnosis of MM

          -  Stage II or III MM at diagnosis or anytime thereafter

          -  Symptomatic MM requiring treatment at diagnosis or anytime thereafter

          -  Received at least three cycles of initial systemic therapy and are within 2-10 months
             of initiation of the initial therapy (this time frame excludes the time for
             mobilization therapy)

          -  If receiving chemotherapy-based mobilization regimens, must be able to receive
             high-dose melphalan between 2 and 8 weeks after the initiation of mobilization therapy
             whether delivered at the transplant center or at a referring center

          -  Adequate organ function as measured by:

               1. Cardiac: Left ventricular ejection fraction at rest greater than 40%

               2. Hepatic: Bilirubin less than 2 times the upper limit of normal and alanine
                  transaminase (ALT) and aspartate transaminase (AST) less than 3 times the upper
                  limit of normal

               3. Renal: Creatinine clearance greater than 40 ml/min (measured or
                  calculated/estimated)

               4. Pulmonary: Carbon monoxide diffusion (DLCO), Volume forcibly exhaled in one
                  second (FEV1), and Forced Vital Capacity (FVC) greater than 50% of predicted
                  value (corrected for hemoglobin), or O2 saturation greater than 92% of room air

          -  An adequate autologous graft defined as a cryopreserved PBSC graft containing at least
             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 10^6 CD34+
             cells/kg patient weight; the graft may not be CD34+ 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 10^6 CD34+ cells/kg patient weight

        Exclusion Criteria:

          -  Never advanced beyond Stage I MM since diagnosis

          -  Non-secretory MM (absence of a monoclonal protein [M protein] in serum as measured by
             electrophoresis and immunofixation and the absence of Bence Jones protein in the urine
             defined by use of conventional electrophoresis and immunofixation techniques)

          -  Plasma cell leukemia

          -  Karnofsky performance score less than 70%, unless approved by the Medical Monitor or
             one of the Protocol Chairs

          -  Uncontrolled hypertension

          -  Uncontrolled bacterial, viral, or fungal infections (currently taking medication and
             progression of clinical symptoms)

          -  Prior malignancies except resected basal cell carcinoma or treated cervical carcinoma
             in situ; cancer treated with curative intent less than 5 years previously will not be
             allowed unless approved by the Medical Monitor or one of the Protocol Chairs; cancer
             treated with curative intent more than 5 years previously will be allowed

          -  Pregnant or breastfeeding

          -  Seropositive for the human immunodeficiency virus (HIV)

          -  Unwilling to use contraceptive techniques during and for 12 months following treatment

          -  Prior allograft or prior autograft

          -  Received mid-intensity melphalan (more than 50 mg IV) as part of prior therapy

          -  Prior organ transplant requiring immunosuppressive therapy