S0204 Thalidomide, Chemotherapy, and Peripheral Stem Cell Transplant in Treating Patients With Multiple Myeloma
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|ClinicalTrials.gov Identifier: NCT00040937|
Recruitment Status : Completed
First Posted : January 27, 2003
Results First Posted : July 17, 2013
Last Update Posted : December 8, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma||Biological: filgrastim Biological: sargramostim Drug: cyclophosphamide Drug: dexamethasone Drug: melphalan Drug: prednisone Drug: thalidomide Procedure: peripheral blood stem cell transplantation||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||147 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Trial Of Thalidomide/Dexamethasone Induction Followed By Tandem Melphalan Transplant And Prednisone/Thalidomide Maintenance (A BMT Study)|
|Study Start Date :||June 2002|
|Primary Completion Date :||October 2008|
|Study Completion Date :||October 2015|
U.S. FDA Resources
Experimental: treatment arm
thalidomide/dexamethasone followed by tandem melphalan peripheral blood stem cell transplantation (with cyclophosphamide and filgrastim or sargramostim support) and prednisone/thalidomide maintenance
PBSC collection: 10 mcg/kg SQ days 1-10
Other Name: G-CSFBiological: sargramostim
PBSC collection: 500 mcg/m2 SQ day 1 through last apheresis
1st and 2nd trans: 500 mcg SC or IV days 6-WBC recovery
Other Name: GM-CSFDrug: cyclophosphamide
PBSC collection: 1 mg/m2 IV over 45-60 mins day 0
Other Name: cytoxanDrug: dexamethasone
40 mg/d PO days 1-4, 9-12, 17-20
Other Name: decadronDrug: melphalan
maint: 50 mg/d PO every other day until progression
Other Name: steroidDrug: thalidomide
ind: 50 mg increased by 50 mg every week to max 400 mg PO qhs for 35 days maint: 50 mg/d increased by 50 mg every week to 200 mg PO daily until progression
Other Name: thalomidProcedure: peripheral blood stem cell transplantation
2-4 x 10^6/kg IV day 0
Other Name: stem cell transplant
- Overall Survival [ Time Frame: 4-7 years ]
- Assess Toxicity of Thalidomide/Dexamethasone as a Pre-transplant Induction Regimen. [ Time Frame: Induction ]To assess Grade 3-5 AE related to thalidomide/dexamethasone when administered as a pre-transplant induction regimen.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00040937
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|Study Chair:||Mohamad A. Hussein, MD||The Cleveland Clinic|