High-Dose Melphalan and a Second Stem Cell Transplant or Low-Dose Cyclophosphamide in Treating Patients With Relapsed Multiple Myeloma After Chemotherapy

This is an interventional treatment trial for Multiple Myeloma and Plasma Cell Neoplasm focused on measuring stage II multiple myeloma, stage III multiple myeloma, refractory multiple myeloma, stage I multiple myeloma Read More

DISEASE CHARACTERISTICS:

• Diagnosis of relapsed multiple myeloma

  • Symptomatic disease, including non-secretory
• Previously treated with standard chemotherapy and autologous stem cell transplantation

• Requires therapy for first progressive disease AND at least 18 months since first stem cell transplantation

  • Patients who were previously immunofixation-negative and are now immunofixation-positive must have > 5 g/L absolute increase in paraprotein
• Registered in the Myeloma X Relapse (Intensive) Trial and received 2-4 courses of PAD re-induction chemotherapy according to the protocol (consolidation phase)
• Adequate stem cell mobilization available for transplantation defined as ≥ 2x10^6 CD34 + cells/kg or ≥ 2x10^8 PBMC/kg including cells stored from a previous harvest (consolidation phase)

PATIENT CHARACTERISTICS:

• ECOG performance status 0-2
• ANC ≥ 1 x 10^9/L
• Platelet count ≥ 50 x 10^9/L
• Creatinine clearance ≥ 30 mL/min
• Total bilirubin < 2 times upper limit of normal (ULN)
• ALT or AST < 2.5 times ULN
• History of pulmonary disease allowed provided carbon monoxide diffusion in the lungs (KCO/DLCO) is ≥ 50% and/or no requirement for supplementary continuous oxygen
• Left ventricular ejection fraction ≥ 40% by ECG or MUGA scan
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for 6 months after completion of study treatment
• No peripheral neuropathy ≥ grade 2
• No known HIV or Hepatitis B or C positivity (testing is not required)
• No known resistance to combined bortezomib, doxorubicin hydrochloride, and dexamethasone therapy
• No known history of allergy to compounds containing boron or mannitol
• No other previous or concurrent malignancies except for appropriately treated localized epithelial skin cancer or carcinoma in situ of the cervix, or remote histories of other cured tumors within the past 5 years
• No medical or psychiatric condition which, in the opinion of the investigator, contraindicates the patient's participation in the study
• No other contra-indication to treatment that would make the patient ineligible for consolidation phase

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• No other prior therapy for relapsed disease except for local radiotherapy, therapeutic plasma exchange, or ≤ 200 mg of dexamethasone

  • Radiotherapy since prior transplantation sufficient to alleviate or control pain of local invasion is permitted
• No hemi-body radiation since prior transplantation (consolidation phase)
• At least 4 weeks since prior and no concurrent investigational drugs