Combination Chemotherapy in Treating Patients With Multiple Myeloma

• Status: Completed
• Trial end date: 2009-12-21
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which combination chemotherapy regimen is most effective in treating patients with multiple myeloma.

PURPOSE: Randomized phase III trial to compare the effectiveness of various combination chemotherapy regimens in treating patients with multiple myeloma.

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

Details

• Lead Sponsor: NCIC Clinical Trials Group
• Treatments: BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Melphalan; Prednisone

Criteria

DISEASE CHARACTERISTICS:

• Histologically proven previously untreated stage I-III multiple myeloma

• Patients with stage I disease must be symptomatic

• Must meet at least 1 of the following conditions:

• Plasma cells in osteolytic lesion or soft tissue tumor biopsy

• At least 10% plasmacytosis in bone marrow aspirate and/or biopsy

• Less than 10% plasma cells in bone marrow but at least 1 bony lesion

• Detectable serum M-component of IgG, IgA, IgD, or IgE

• If only light chain disease (urine M-protein) present, urinary excretion of light chain (Bence Jones) protein must be at least 1.0 g/24 hours

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• ECOG 0-4

Life expectancy:

• Not specified

Hematopoietic:

• Not specified

Hepatic:

• Not specified

Renal:

• Not specified

Other:

• No other concurrent serious illness

• Concurrent diabetes allowed, at the discretion of the treating physician, if changes in insulin requirements can be managed

• No other prior or concurrent malignancy except curatively treated nonmelanomatous skin cancer or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• No concurrent immunizations

• No concurrent filgrastim (G-CSF) or other growth factors as prophylaxis

• Concurrent epoetin alfa for anemia allowed

Chemotherapy:

• No prior chemotherapy

Endocrine therapy:

• Prior dexamethasone or prednisone with radiotherapy for spinal cord compression allowed if cumulative dexamethasone dose no greater than 120 mg and cumulative prednisone dose no greater than 792 mg

• Prior or concurrent corticosteroids for hypercalcemia allowed

Radiotherapy:

• See Endocrine therapy

• Prior focal radiotherapy allowed

• Concurrent focal radiotherapy during induction allowed

• Concurrent radiotherapy for palliation (e.g., painful osteolytic lesions or spinal cord compression) allowed

Surgery:

• At least 2 years since prior surgery for radiologic or endoscopic diagnosis of gastric or duodenal ulcer

Other:

• At least 2 years since prior medication for radiologic or endoscopic diagnosis of gastric or duodenal ulcer

• Prior or concurrent bisphosphonates for hypercalcemia allowed