Overview

S9922 Combination Chemo Plus Filgrastim With or Without Thalidomide in Refractory Multiple Myeloma

Status:
Terminated
Trial end date:
2007-11-01
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. Thalidomide may stop the growth of tumor cells by stopping blood flow to the tumor. It is not yet known if combination chemotherapy is more effective with or without thalidomide for multiple myeloma. PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy with or without thalidomide in treating patients who have refractory multiple myeloma.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Southwest Oncology Group
Collaborator:
National Cancer Institute (NCI)
Treatments:
BB 1101
Cisplatin
Cyclophosphamide
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Etoposide
Etoposide phosphate
Lenograstim
Thalidomide
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