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

Launched by SWOG CANCER RESEARCH NETWORK · Aug 8, 2003

Keywords

ClinConnect Summary

OBJECTIVES:

* Compare tumor cytoreduction achieved with VBMCP (vincristine/carmustine/melphalan/cyclophosphamide/prednisone) vs myeloablative melphalan (L-PAM) and total-body irradiation (TBI) with peripheral blood stem cell (PBSC) rescue in symptomatic myeloma patients with stable or responding disease after induction therapy with VAD (vincristine/doxorubicin/dexamethasone) followed by high dose cyclophosphamide plus filgrastim (G-CSF).
* Compare the efficacy of interferon alfa vs no maintenance therapy in those patients achieving at least 75% cytoreduction to either VBMCP or myeloablativ...

Gender

ALL

Eligibility 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

Trial Officials