SWOG clinical trial number
S9922

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

Closed
Phase
Accrual
6%
Abbreviated Title
Refractory Myeloma
Activated
04/15/2000
Closed
11/01/2001
Participants

Research committees

Myeloma

Treatment

Cisplatin Cyclophosphamide Dexamethasone Etoposide Filgrastim Thalidomide DCEP

Eligibility Criteria Expand/Collapse

Patients must have a confirmed diagnosis of previously treated, active multiple myeloma (MM). Protein criteria must be present. Patients must have received at least one and at most four prior treatment regimens for MM including chemotherapy, bone marrow transplant, biologic, radiotherapy and/or both (i.e., VAD followed by transplant is considered one regimen. Interferon or steroid pulsing given as maintenance therapy after transplant or chemotherapy is not considered a separate treatment regimen. One course or cycle of treatment is not considered one treatment regimen). Prior treatment with thalidomide is allowed (if patient has received <= 3 months of thalidomide therapy). Patients must be off chemotherapy (excluding steroids) and radiotherapy (either extensive or limited) for >= 3 weeks prior to registration. Patients who have not received thalidomide must have shown, in the opinion of the investigator, indications of disease progression. Patients must have a Zubrod performance status of 0-2, however PS of 3-4 based solely on bone pain will be eligible. Patient must have adequate hepatic and renal function and no preexisting peripheral neuropathy >/= Grade 2 at the time of registration. Patients must be made fully aware of the teratogenic potential of thalidomide and agree to fully comply with the guidelines regarding contraception in the informed consent and the patient warning letter attached to the consent form. Before starting treatment, women of childbearing potential must have a negative pregnancy test performed within 24 hours prior to beginning therapy.