SWOG-9321 Melphalan, TBI, and Transplant vs Combo Chemo in Untreated Myeloma

• Status: Completed
• Trial end date: 2006-11-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer cells. Combining chemotherapy and radiation therapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy and radiation therapy and kill more cancer cells. It is not yet known which treatment regimen is more effective for multiple myeloma.

PURPOSE: Randomized phase III trial to compare the effectiveness of melphalan, total-body irradiation, and peripheral stem cell transplantation with that of combination chemotherapy in treating patients who have previously untreated multiple myeloma.

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

Details

• Lead Sponsor: Southwest Oncology Group
• Collaborators: Cancer and Leukemia Group B; Eastern Cooperative Oncology Group; National Cancer Institute (NCI)
• Treatments: Carmustine; Cyclophosphamide; Dexamethasone; Doxorubicin; Interferon-alpha; Interferons; Liposomal doxorubicin; Melphalan; Prednisone; Vincristine

Criteria

DISEASE CHARACTERISTICS:

• Newly diagnosed, active multiple myeloma of any stage requiring treatment

• Smoldering myeloma (Durie-Salmon stage I) must have a 25% or greater increase in M component levels and/or Bence-Jones protein excretion or development of symptoms

• Quantifiable M component of IgG, IgA, IgD, IgE, and/or urinary kappa or lambda light chain (Bence-Jones protein) excretion required

• Plasmacytosis of at least 30% allowed for non-secretory disease or secretory disease without quantifiable protein

• IgM peaks excluded

• Evaluation of siblings as potential allogeneic bone marrow transplant donors required for patients 55 years of age and younger (As of 8/1/97, permanently closed)

• HLA followed by DR and MLC testing required

• Renal failure, even on dialysis, eligible provided:

• Cause is attributed to myeloma (Bence-Jones protein or hypercalcemia)

• Duration does not exceed 2 months

• If medically appropriate, the following conditions should be treated prior to registration:

• Pathologic fractures

• Pneumonia at diagnosis

• Hyperviscosity with shortness of breath

PATIENT CHARACTERISTICS:

Age:

• 70 and under

Performance status:

• SWOG 0-2 (SWOG 3 or 4 based solely on bone pain allowed)

Hematopoietic:

• Not specified

Hepatic:

• Not specified

Renal:

• See Disease Characteristics

Cardiovascular:

• Normal ejection fraction by ECHO or MUGA

• No myocardial infarction within 6 months

• No unstable angina

• No difficult to control congestive heart failure

• No uncontrolled hypertension

• No difficult to control arrhythmias

• No history of chronic cerebral vascular accident

Pulmonary:

• No history of chronic obstructive or restrictive pulmonary disease

• Pulmonary function studies and DLCO at least 50% of predicted except for demonstrated myeloma involvement on bronchoscopy and/or open lung biopsy

Other:

• No uncontrolled diabetes

• No significant comorbid medical condition

• No uncontrolled, life-threatening infection

• No prior malignancy within 5 years except adequately treated nonmelanoma skin cancer or carcinoma in situ of the cervix

• No prior malignancy treated with cytotoxic drugs used on this protocol

• Not pregnant or nursing

• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• No prior chemotherapy

Endocrine therapy:

• Not specified

Radiotherapy:

• No prior radiotherapy except local radiotherapy provided the following cumulative dose limits for prior dose plus potential TBI dose on protocol are not exceeded:

• Less than 5,000 cGy to bone

• Less than 4,000 cGy to mediastinum, heart, small bowel, brain, and spinal cord

• Less than 2,000 cGy to the liver

• Less than 1,500 cGy to the kidney and lungs

Surgery:

• Not specified