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

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Giving chemotherapy and bortezomib before a peripheral stem cell transplant stops the growth of cancer cells by stopping them from dividing or killing them. Giving colony-stimulating factors, such as G-CSF, and certain chemotherapy drugs, helps stem cells move from the bone marrow to the blood so they can be collected and stored. Chemotherapy is then given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy and bortezomib. It is not yet known whether high-dose melphalan given together with a second stem cell transplant is more effective than low-dose cyclophosphamide in treating patients with relapsed multiple myeloma.

PURPOSE: This randomized phase III trial is studying giving high-dose melphalan together with a second stem cell transplant to see how well it works compared with low-dose cyclophosphamide in treating patients with relapsed multiple myeloma after chemotherapy.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Leeds Cancer Centre at St. James's University Hospital
• Treatments: Cyclophosphamide; Melphalan

Criteria

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