S0204 Thalidomide, Chemotherapy, and Peripheral Stem Cell Transplant in Treating Patients With Multiple Myeloma

Phase 2

Completed

Conditions: Multiple Myeloma

Interventions: Biological: filgrastim
Biological: sargramostim
Drug: cyclophosphamide
Drug: dexamethasone
Drug: melphalan
Drug: prednisone
Drug: thalidomide
Procedure: peripheral blood stem cell transplantation

Registration Number: NCT00040937

Lead Sponsor: SWOG Cancer Research Network

Brief Summary: RATIONALE: Thalidomide may stop the growth of cancer cells by stopping blood flow to the cancer. Drugs used in chemotherapy work in different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplant may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. Giving thalidomide before and after peripheral stem cell transplant may be effective in treating newly diagnosed multiple myeloma.

PURPOSE: This phase II trial is studying how well giving thalidomide with chemotherapy and peripheral stem cell transplant work in treating patients with newly diagnosed multiple myeloma.

Detailed Description: OBJECTIVES:

* Determine the efficacy and toxicity of thalidomide and dexamethasone as a pre-transplantation induction regimen in patients with multiple myeloma.

* Determine, preliminarily, the safety and efficacy of prednisone and thalidomide maintenance therapy in these patients.

* Correlate chromosome 13 abnormalities with therapeutic response in patients treated with this regimen.

* Correlate specific subsets of chromosome aberrations with event-free and overall survival of patients treated with this regimen.

* Evaluate immune reconstitution and recovery after first and second transplantation in these patients.

OUTLINE: This is a multicenter study.

* Induction chemotherapy: Patients receive oral thalidomide once daily on days 1-35 and oral dexamethasone once daily on days 1-4, 9-12, and 17-20. Treatment repeats every 35 days for 3 courses in the absence of disease progression or unacceptable toxicity.

* Stem cell mobilization and collection: Beginning 5-7 days, but no more than 3 weeks, after completion of induction chemotherapy, patients receive cyclophosphamide IV over 45-60 minutes on day 0, filgrastim (G-CSF) subcutaneously (SC) on days 1-10, and sargramostim (GM-CSF) SC beginning on day 1 and continuing until completion of peripheral blood stem cell (PBSC) collection. Patients begin PBSC collection on day 11 or as soon as blood counts recover.

* First transplantation: Within 3-6 weeks after cyclophosphamide administration, patients receive melphalan IV over 20 minutes on day -1. Patients undergo PBSC infusion on day 0. Patients receive GM-CSF SC or IV beginning on day 6 and continuing until blood counts recover.

* Second transplantation: Between 2-4 months after first transplantation, patients undergo a second tandem melphalan and PBSC transplantation with GM-CSF support as above.

* Maintenance therapy: Beginning 70-90 days post-transplantation, patients receive oral prednisone every other day and oral thalidomide once daily. Treatment continues in the absence of disease progression or unacceptable toxicity.

Patients are followed every 12 months for 10 years.

PROJECTED ACCRUAL: Approximately 99 patients will be accrued for this study within 18 months.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 147

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
treatment arm	filgrastim	thalidomide/dexamethasone followed by tandem melphalan peripheral blood stem cell transplantation (with cyclophosphamide and filgrastim or sargramostim support) and prednisone/thalidomide maintenance
treatment arm	sargramostim	thalidomide/dexamethasone followed by tandem melphalan peripheral blood stem cell transplantation (with cyclophosphamide and filgrastim or sargramostim support) and prednisone/thalidomide maintenance
treatment arm	peripheral blood stem cell transplantation	thalidomide/dexamethasone followed by tandem melphalan peripheral blood stem cell transplantation (with cyclophosphamide and filgrastim or sargramostim support) and prednisone/thalidomide maintenance
treatment arm	dexamethasone	thalidomide/dexamethasone followed by tandem melphalan peripheral blood stem cell transplantation (with cyclophosphamide and filgrastim or sargramostim support) and prednisone/thalidomide maintenance
treatment arm	melphalan	thalidomide/dexamethasone followed by tandem melphalan peripheral blood stem cell transplantation (with cyclophosphamide and filgrastim or sargramostim support) and prednisone/thalidomide maintenance
treatment arm	cyclophosphamide	thalidomide/dexamethasone followed by tandem melphalan peripheral blood stem cell transplantation (with cyclophosphamide and filgrastim or sargramostim support) and prednisone/thalidomide maintenance
treatment arm	prednisone	thalidomide/dexamethasone followed by tandem melphalan peripheral blood stem cell transplantation (with cyclophosphamide and filgrastim or sargramostim support) and prednisone/thalidomide maintenance
treatment arm	thalidomide	thalidomide/dexamethasone followed by tandem melphalan peripheral blood stem cell transplantation (with cyclophosphamide and filgrastim or sargramostim support) and prednisone/thalidomide maintenance

Primary Outcome Measures

Name	Time	Method
Overall Survival	4-7 years

Secondary Outcome Measures

Name	Time	Method
Assess Toxicity of Thalidomide/Dexamethasone as a Pre-transplant Induction Regimen.	Induction	To assess Grade 3-5 AE related to thalidomide/dexamethasone when administered as a pre-transplant induction regimen.

Trial Locations

Locations (141): Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
🇺🇸
Little Rock, Arkansas, United States
University of California Davis Cancer Center
🇺🇸
Davis, California, United States
Sutter Roseville Medical Center
🇺🇸
Roseville, California, United States
Sutter Cancer Center
🇺🇸
Sacramento, California, United States
Piedmont Hospital
🇺🇸
Atlanta, Georgia, United States
CCOP - Atlanta Regional
🇺🇸
Atlanta, Georgia, United States
Northside Hospital Cancer Center
🇺🇸
Atlanta, Georgia, United States
Saint Joseph's Hospital of Atlanta
🇺🇸
Atlanta, Georgia, United States
WellStar Cobb Hospital
🇺🇸
Austell, Georgia, United States
Charles B. Eberhart Cancer Center at DeKalb Medical Center
🇺🇸
Decatur, Georgia, United States
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Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States