A Phase II Trial Of Thalidomide/Dexamethasone Induction Followed By Tandem Melphalan Transplant And Prednisone/Thalidomide Maintenance (A BMT Study)

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Newly diagnosed multiple myeloma requiring treatment

- Smoldering myeloma with evidence of progressive disease requiring chemotherapy

- More than 25% increase in M component levels and/or Bence-Jones excretion
or symptom development

- Non-secretory patients with at least 30% bone marrow plasmacytosis

- No IgM peaks unless there is evidence of more than 30% bone marrow plasmacytosis or
more than 3 lytic lesions

PATIENT CHARACTERISTICS:

Age

- 18 to 65

Performance status

- Zubrod 0-2 OR

- Zubrod 3-4 based solely on bone pain

Life expectancy

- Not specified

Hematopoietic

- No untreated, unresolved symptomatic hyperviscosity

Hepatic

- Hepatitis B negative

Renal

- Creatinine no greater than 3 mg/dL if in renal failure and on dialysis (after
hydration and/or correction of hypercalcemia)

Cardiovascular

- No history of chronic cerebrovascular accident

- No myocardial infarction within the past 6 months

- No unstable angina

- No congestive heart failure that is difficult to control

- No uncontrollable hypertension

- No cardiac arrhythmia that is difficult to control

Pulmonary

- No history of chronic obstructive or chronic restrictive pulmonary disease

- No untreated, unresolved pneumonia

- Pulmonary function tests (PFTs) at least 50% of predicted

- DLCO at least 50% of predicted

- Arterial partial pressure of oxygen greater than 70 if unable to complete PFTs due to
bone pain or fracture

Other

- HIV negative

- No other malignancy within the past 5 years except adequately treated basal cell or
squamous cell skin cancer or carcinoma in situ of the cervix

- No untreated, unresolved pathologic fractures

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use at least 2 highly effective methods of contraception for 4
weeks before, during, and for at least 4 weeks after study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

- No more than 8 weeks of prior thalidomide therapy

Chemotherapy

- No prior chemotherapy for this disease

Endocrine therapy

- Prior steroid therapy allowed provided treatment duration was no more than 2 weeks

Radiotherapy

- No prior radiotherapy to more than 50% of the pelvis

Surgery

- Not specified