Doxorubicin Hydrochloride Liposome, Melphalan, and Bortezomib in Treating Patients With Relapsed or Refractory Stage I, Stage II, or Stage III Multiple Myeloma
Multiple Myeloma and Plasma Cell Neoplasm
About this trial
This is an interventional treatment trial for Multiple Myeloma and Plasma Cell Neoplasm focused on measuring refractory multiple myeloma, stage I multiple myeloma, stage II multiple myeloma, stage III multiple myeloma
Eligibility Criteria
DISEASE CHARACTERISTICS: Diagnosis of multiple myeloma Stage I, II, or III disease according to Durie-Salmon staging criteria Progressive disease, defined as one of the following: For secretory disease: A 25% increase in serum M-protein or Bence Jones protein (an absolute increase of 0.5 g/dL serum M-protein or ≥ 200 mg/24 hours of urine light chain excretion) For nonsecretory disease: Bone marrow biopsy with > 25% increase in plasma cells or an absolute increase of ≥ 10% over prior known level Development of new or worsening existing lytic bone lesions or soft tissue plasmacytomas Hypercalcemia (i.e., calcium > 11.5 mg/dL) Relapsed after complete response Must have received ≥ 2 of the following therapeutic regimens for multiple myeloma: Nonmyeloablative transplantation No significant graft-versus-host disease At least 30 days since prior immunosuppressive therapy (concurrent prednisone allowed provided dose is ≤ 10 mg daily) Mobilization with chemotherapy followed by either single or tandem autologous stem cell transplantation (considered 1 prior regimen) Mobilization with chemotherapy followed by autologous and subsequent nonmyeloablative allogeneic stem cell transplantation (considered 1 prior regimen) Any combination of drugs given concurrently (considered 1 prior regimen) PATIENT CHARACTERISTICS: ECOG performance status 0-2 Life expectancy ≥ 3 months Absolute neutrophil count > 1,000/mm^3 (no colony-stimulating factors) Platelet count > 50,000/mm^3 (no transfusion support) Bilirubin ≤ 2.0 mg/dL AST ≤ 4 times upper limit of normal Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 4 weeks after completion of study treatment No history of allergic reaction to compounds containing boron or mannitol No active uncontrolled viral (including HIV), bacterial, or fungal infection No motor or sensory neuropathy ≥ grade 2 No myocardial infarction within the past 6 months No New York Heart Association class III or IV heart failure No uncontrolled angina No severe uncontrolled arrhythmia No acute ischemia by EKG LVEF ≥ 35% by MUGA (MUGA required in patients whose lifetime cumulative doxorubicin hydrochloride dose > 400 mg/m^2) PRIOR CONCURRENT THERAPY: See Disease Characteristics No grade III or IV toxicity due to previous antineoplastic therapy (except alopecia) At least 3 weeks since prior chemotherapy No prior doxorubicin HCl liposome, melphalan, and bortezomib as combination therapy (single or two-drug combinations of these are allowed) No concurrent corticosteroids (≤ 10 mg prednisone/day or equivalent allowed) No other concurrent chemotherapy No concurrent thalidomide No other concurrent investigational therapy No other concurrent antineoplastic treatment for multiple myeloma, including clarithromycin No concurrent radiation therapy No concurrent nonsteroidal anti-inflammatory agents
Sites / Locations
- UCSF Helen Diller Family Comprehensive Cancer CenterRecruiting
- Herbert Irving Comprehensive Cancer Center at Columbia University Medical CenterRecruiting