A Phase III Trial of Dexamethasone, Cyclophosphamide, Etoposide, Cisplatin (DCEP) and G-CSF With or Without Thalidomide (NSC #66847) as Salvage Therapy for Patients With Refractory Multiple Myeloma

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed stage I, II, or III
multiple myeloma with protein criteria present Quantifiable M-components of IgG, IgA, IgD,
IgE AND/OR Urinary kappa or lambda light chain excretion No IgM peaks Quantifiable
monoclonal proteins Received at least 1, but no more than 4 prior treatment regimens,
including the following: Chemotherapy Bone marrow transplantation Biologic therapy
Radiotherapy Interferon therapy or steroid pulsing given as maintenance therapy after
transplantation or chemotherapy is not considered a separate treatment regimen Progressive
disease

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Zubrod 0-2 (3-4 allowed if
due solely to bone pain) Life expectancy: At least 3 months Hematopoietic: Absolute
granulocyte count at least 1,000/mm3 Platelet count at least 50,000/mm3 (at least 50%
plasma cells in bone marrow) Hepatic: Bilirubin no greater than 2.5 times upper limit of
normal (ULN) SGOT or SGPT no greater than 2.5 times ULN Renal: Creatinine no greater than
2.0 mg/dL OR Creatinine clearance at least 60 mL/min Other: Not pregnant or nursing
Negative pregnancy test Fertile patients must use 2 methods of effective contraception for
4 weeks before, during, and for 4 weeks after study No other prior or concurrent
malignancies within the past 5 years except adequately treated basal cell or squamous cell
skin cancer, carcinoma in situ of the cervix, or any other adequately treated stage I or
II cancer in complete remission No grade 2 or greater preexisting peripheral neuropathy

PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics Prior thalidomide
allowed if received less than 3 months of therapy Recovered from prior biologic therapy
Chemotherapy: See Disease Characteristics At least 3 weeks since prior chemotherapy and
recovered No other concurrent chemotherapy Endocrine therapy: See Disease Characteristics
No concurrent hormonal therapy Radiotherapy: See Disease Characteristics At least 3 weeks
since prior extensive or limited radiotherapy and recovered No concurrent radiotherapy
Surgery: Not specified