Combination Chemotherapy With or Without High Dose Cyclophosphamide and Recombinant Interferon Alfa-2b in Treating Patients With Previously Untreated Stage I-III Multiple Myeloma

Completed · Phase 3

Conditions studied: Stage I Multiple Myeloma, Stage II Multiple Myeloma, Stage III Multiple Myeloma

In brief

This randomized phase III clinical trial studies combination chemotherapy with high dose cyclophosphamide and recombinant interferon alfa-2b to see how well it works compared to combination chemotherapy alone in treating patients with previously untreated stage I-III multiple myeloma. Drugs used in chemotherapy, such as vincristine sulfate, carmustine, melphalan, cyclophosphamide, and prednisone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Recombinant interferon alfa-2b may interfere with the growth of cancer cells. It is not yet know whether giving combination chemotherapy with or without alternating high-dose cyclophosphamide and recombinant interferon alfa-2b is more effective in treating multiple myeloma.

Key facts

Study ID

NCT00002556

Run by

National Cancer Institute (NCI)

People needed

312

Starts

1994-07-01

Last updated by the study team

2013-05-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients must have a diagnosis of multiple myeloma confirmed by the presence of:
• Bone marrow plasmacytosis with >= 10% plasma cells or sheets of plasma cells or biopsy-proven plasmacytoma
• In addition, at least 1 of the following ancillary criteria must be documented:
• M-protein in the serum
• M-protein in the urine
• Radiographic evidence of osteolytic lesions (generalized osteoporosis qualifies only if the bone marrow aspirate contains >= 20% plasma cells)
• Patients must have measurable disease; the following will constitute measurable disease; tests used to document measurable disease must be done within two weeks prior to registration; a bone marrow biopsy performed =< 6 weeks prior to registration is acceptable; Note: If present, all of these parameters must be followed for response
• Serum M-protein >= 1.0 g/dL by serum protein electrophoresis
• Urine M-protein (light chain) excretion > 200 mg/24 hours by urine protein electrophoresis
• Measurable plasmacytoma(s) of soft tissue (must be biopsy proven)
• Bone marrow plasmacytosis >= 20%
• Patients must not have been previously treated with chemotherapy; prior treatment of hypercalcemia with corticosteroids, bisphosphonates, or other agents does not disqualify the patient
• Patients refuses entry or is ineligible for S9321; Note: S9321, "Standard Dose Versus Myeloablative Therapy for Previously Untreated Symptomatic Multiple Myeloma" has priority over E5A93; patients with previously untreated multiple myeloma should be entered on S9321; patients who are ineligible for or decline entry to S9321 should be entered on E5A93 and E3A93 if eligible
• Patients treated with local radiotherapy to > 15% of the bone marrow area are ineligible; patients who require concurrent radiotherapy should have entry to the protocol deferred until the radiotherapy is completed; if, in the physician's opinion, the delay in systemic therapy would itself pose undue risk, the patient may be entered and receive concurrent radiotherapy; in this situation, for the first VBMCP cycle, Melphalan, BCNU and Cyclophosphamide should be given at 75% of the dose
• Patients with Stages I, II, or III disease according to a modification of the clinical staging system by Durie and Salmon are eligible; staging should be based on values obtained at the time of diagnosis unless patient has had a more abnormal value prior to supportive treatment, transfusion, etc.; include only values obtained prior to initiation of protocol treatment
• Pretreatment x-rays must be done within 6 weeks of registration; copies of the bone x-ray reports are required and must be submitted with on-study forms
• Bone marrow slides must be submitted
• Absolute neutrophil count (ANC) >= 1,000/mm\^3
• Platelet count >= 50,000/mm\^3
• Creatinine =< 5.0 mg/dL (NOTE: Patients with creatinine 2.0-5.0 mg/dL may be admitted to this study but must receive altered doses and schedules of therapy)
• Patients requiring dialysis are not eligible
• Bilirubin =< 2.0 mg/dL
• Serum glutamic oxaloacetic transaminase (SGOT) =< 2.5 x upper limit of normal
• Alkaline phosphatase =< 2.5 x upper limit of normal
• No myocardial infarction within previous 6 months, no significant arrhythmia within the prior 3 months; if hypertension is present, it should be under control prior to study entry

Where it is running

• Eastern Cooperative Oncology Group — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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