Combination Chemotherapy in Treating Patients With Multiple Myeloma
- Conditions
- Multiple Myeloma and Plasma Cell Neoplasm
- Interventions
- Registration Number
- NCT00002678
- Lead Sponsor
- NCIC Clinical Trials Group
- Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which combination chemotherapy regimen is most effective in treating patients with multiple myeloma.
PURPOSE: Randomized phase III trial to compare the effectiveness of various combination chemotherapy regimens in treating patients with multiple myeloma.
- Detailed Description
OBJECTIVES:
* Compare the overall survival of patients with previously untreated stage I-III multiple myelome treated with melphalan combined with dexamethasone or prednisone as induction therapy.
* Compare the overall survival of patients with stable or responding disease after induction treated with dexamethasone vs observation alone as maintenance therapy.
* Compare the time to progression, response rate, and quality of life of patients treated with these regimens.
* Compare the toxic effects of these regimens in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified by center, stage (I or II vs III), creatinine (less than 2.0 mg/dL vs 2.0 mg/dL or greater), and intention to use prophylactic bisphosphonate (yes vs no).
* Induction: Patients are randomized to 1 of 4 treatment arms.
* Arms I and II: Patients receive induction comprising oral prednisone followed by oral melphalan on days 1-4.
* Arms III and IV: Patients receive induction comprising oral melphalan and oral dexamethasone (DM) on days 1-4 of all courses and DM on days 15-18 of courses 1-3.
Induction for arms I-IV continues every 4 weeks for 12 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease after induction proceed to maintenance therapy.
* Maintenance:
* Arms I and III: Patients undergo observation.
* Arms II and IV: Patients receive oral DM on days 1-4. Maintenance therapy continues every 4 weeks for arms II and IV and every 3 months for arms I and III in the absence of disease progression or unacceptable toxicity. Patients on arms I-IV who develop disease progression proceed to reinduction.
* Reinduction: Patients restart induction on the arm to which they were originally randomized. Reinduction continues every 4 weeks in the absence of stable response lasting 16 weeks, disease progression, or unacceptable toxicity. Patients who achieve a stable response lasting 16 weeks restart maintenance therapy. Patients who experience further disease progression during reinduction are taken off study.
Quality of life is assessed at baseline, on day 1 of courses 1-3 and then every 3 courses during induction, and then every 3 months during maintenance therapy.
Patients are followed every 6 months.
PROJECTED ACCRUAL: A maximum of 600 patients will be accrued for this study within 6 years.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 595
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Melphan plus prednisone prednisone melphalan plus prednisone qd x 4 28 day cycles x 12 cycles; No treatment after stable response. Melphan, prednisone pluse dexamethasone dexamethasone melphalan plus prednisone qd x 4 28 day cycles x 12 cycles; dexamethasone qd x 4 q 28 days after non-progression Melphan plus prednisone melphalan melphalan plus prednisone qd x 4 28 day cycles x 12 cycles; No treatment after stable response.
- Primary Outcome Measures
Name Time Method Overall survival 9 years To compare overall survival between:
i) patients receiving melphalan-prednisone and those receiving melphalan-dexamethasone as induction therapy ii) patients maintained by dexamethasone and those on no additional treatment in the subgroup whose disease has not progressed at the time of the 12th induction cycle
- Secondary Outcome Measures
Name Time Method Time to progression 9 years Response rates 9 years Toxicity 9 years Quality of Life 9 years
Trial Locations
- Locations (37)
St. Mary's/Duluth Clinic Health System
🇺🇸Duluth, Minnesota, United States
Tom Baker Cancer Center - Calgary
🇨🇦Calgary, Alberta, Canada
Cross Cancer Institute
🇨🇦Edmonton, Alberta, Canada
British Columbia Cancer Agency - Centre for the Southern Interior
🇨🇦Kelowna, British Columbia, Canada
British Columbia Cancer Agency
🇨🇦Vancouver, British Columbia, Canada
Providence Health Care - Vancouver
🇨🇦Vancouver, British Columbia, Canada
British Columbia Cancer Agency - Vancouver Island Cancer Centre
🇨🇦Victoria, British Columbia, Canada
Moncton Hospital
🇨🇦Moncton, New Brunswick, Canada
Doctor Leon Richard Oncology Centre
🇨🇦Moncton, New Brunswick, Canada
Saint John Regional Hospital
🇨🇦Saint John, New Brunswick, Canada
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