Combination Chemotherapy in Treating Patients With Multiple Myeloma

Launched by NCIC CLINICAL TRIALS GROUP · Jan 26, 2003

Keywords

ClinConnect Summary

OBJECTIVES:

* Compare the overall survival of patients with previously untreated stage I-III multiple myelome treated with melphalan combined with dexamethasone or prednisone as induction therapy.
* Compare the overall survival of patients with stable or responding disease after induction treated with dexamethasone vs observation alone as maintenance therapy.
* Compare the time to progression, response rate, and quality of life of patients treated with these regimens.
* Compare the toxic effects of these regimens in these patients.

OUTLINE: This is a randomized, multicenter study. Patient...

Gender

ALL

Eligibility 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

Trial Officials