Combination Chemotherapy in Treating Patients With Multiple Myeloma
NCT ID: NCT00002678
Last Updated: 2020-04-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
595 participants
INTERVENTIONAL
1995-06-02
2009-12-21
Brief Summary
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PURPOSE: Randomized phase III trial to compare the effectiveness of various combination chemotherapy regimens in treating patients with multiple myeloma.
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Detailed Description
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* 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Melphan plus prednisone
melphalan plus prednisone qd x 4 28 day cycles x 12 cycles; No treatment after stable response.
melphalan
9 mg/m2 daily for 4 days given orally on an empty stomach every 4 weeks
prednisone
100 mg daily for 4 days given orally on a full stomach with each cycle of melphalan
Melphan, prednisone pluse dexamethasone
melphalan plus prednisone qd x 4 28 day cycles x 12 cycles; dexamethasone qd x 4 q 28 days after non-progression
dexamethasone
40 mg daily for four days given orally and repeated every 28 days should commence on day 29 of the twelfth cycle of induction therapy.
Interventions
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dexamethasone
40 mg daily for four days given orally and repeated every 28 days should commence on day 29 of the twelfth cycle of induction therapy.
melphalan
9 mg/m2 daily for 4 days given orally on an empty stomach every 4 weeks
prednisone
100 mg daily for 4 days given orally on a full stomach with each cycle of melphalan
Eligibility Criteria
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Inclusion Criteria
* Histologically proven previously untreated stage I-III multiple myeloma
* Patients with stage I disease must be symptomatic
* Must meet at least 1 of the following conditions:
* Plasma cells in osteolytic lesion or soft tissue tumor biopsy
* At least 10% plasmacytosis in bone marrow aspirate and/or biopsy
* Less than 10% plasma cells in bone marrow but at least 1 bony lesion
* Detectable serum M-component of IgG, IgA, IgD, or IgE
* If only light chain disease (urine M-protein) present, urinary excretion of light chain (Bence Jones) protein must be at least 1.0 g/24 hours
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* ECOG 0-4
Life expectancy:
* Not specified
Hematopoietic:
* Not specified
Hepatic:
* Not specified
Renal:
* Not specified
Other:
* No other concurrent serious illness
* Concurrent diabetes allowed, at the discretion of the treating physician, if changes in insulin requirements can be managed
* No other prior or concurrent malignancy except curatively treated nonmelanomatous skin cancer or carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* No concurrent immunizations
* No concurrent filgrastim (G-CSF) or other growth factors as prophylaxis
* Concurrent epoetin alfa for anemia allowed
Chemotherapy:
* No prior chemotherapy
Endocrine therapy:
* Prior dexamethasone or prednisone with radiotherapy for spinal cord compression allowed if cumulative dexamethasone dose no greater than 120 mg and cumulative prednisone dose no greater than 792 mg
* Prior or concurrent corticosteroids for hypercalcemia allowed
Radiotherapy:
* See Endocrine therapy
* Prior focal radiotherapy allowed
* Concurrent focal radiotherapy during induction allowed
* Concurrent radiotherapy for palliation (e.g., painful osteolytic lesions or spinal cord compression) allowed
Surgery:
* At least 2 years since prior surgery for radiologic or endoscopic diagnosis of gastric or duodenal ulcer
Other:
* At least 2 years since prior medication for radiologic or endoscopic diagnosis of gastric or duodenal ulcer
* Prior or concurrent bisphosphonates for hypercalcemia allowed
18 Years
120 Years
ALL
No
Sponsors
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NCIC Clinical Trials Group
NETWORK
Responsible Party
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Principal Investigators
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Chaim Shustik, MD
Role: STUDY_CHAIR
Royal Victoria Hospital - Montreal
Locations
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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
Newfoundland Cancer Treatment and Research Foundation
St. John's, Newfoundland and Labrador, Canada
Nova Scotia Cancer Centre
Halifax, Nova Scotia, Canada
William Osler Health Centre
Brampton, Ontario, Canada
Northeastern Ontario Regional Cancer Centre, Sudbury
Greater Sudbury, Ontario, Canada
Cancer Care Ontario-Hamilton Regional Cancer Centre
Hamilton, Ontario, Canada
Kingston Regional Cancer Centre
Kingston, Ontario, Canada
Cancer Care Ontario-London Regional Cancer Centre
London, Ontario, Canada
Trillium Health Centre
Mississauga, Ontario, Canada
Credit Valley Hospital
Mississauga, Ontario, Canada
Southlake Regional Health Centre
Newmarket, Ontario, Canada
Lakeridge Health Oshawa
Oshawa, Ontario, Canada
Algoma District Medical Group
Sault Ste. Marie, Ontario, Canada
Hotel Dieu Health Sciences Hospital - Niagara
St. Catharines, Ontario, Canada
Toronto East General Hospital
Toronto, Ontario, Canada
Toronto Sunnybrook Regional Cancer Centre
Toronto, Ontario, Canada
St. Michael's Hospital - Toronto
Toronto, Ontario, Canada
Toronto General Hospital
Toronto, Ontario, Canada
Princess Margaret Hospital
Toronto, Ontario, Canada
Humber River Regional Hospital
Weston, Ontario, Canada
Cancer Care Ontario - Windsor Regional Cancer Centre
Windsor, Ontario, Canada
Queen Elizabeth Hospital, PEI
Charlottetown, Prince Edward Island, Canada
CHUS-Hopital Fleurimont
Fleurimont, Quebec, Canada
Hopital Charles Lemoyne
Greenfield Park, Quebec, Canada
McGill University
Montreal, Quebec, Canada
Hopital de L'Enfant Jesus
Québec, Quebec, Canada
Hopital du Saint-Sacrement, Quebec
Québec, Quebec, Canada
Allan Blair Cancer Centre
Regina, Saskatchewan, Canada
Countries
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References
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Shustik C, Belch A, Robinson S, Rubin SH, Dolan SP, Kovacs MJ, Grewal KS, Walde D, Barr R, Wilson J, Gill K, Vickars L, Rudinskas L, Sicheri DA, Wilson K, Djurfeldt M, Shepherd LE, Ding K, Meyer RM. A randomised comparison of melphalan with prednisone or dexamethasone as induction therapy and dexamethasone or observation as maintenance therapy in multiple myeloma: NCIC CTG MY.7. Br J Haematol. 2007 Jan;136(2):203-11. doi: 10.1111/j.1365-2141.2006.06405.x.
Shustik C, Belch A, Robinson S, et al.: Dexamethasone (dex) maintenance versus observation (obs) in patients with previously untreated multiple myeloma: a National Cancer Institute of Canada Clinical Trials Group study: MY.7. [Abstract] J Clin Oncol 22 (Suppl 14): A-6510, 560s, 2004.
Shustik C, Belch A, Meyer R, et al.: Melphalan-dexamethasone is not superior to melphalan-prednisone as induction therapy in multiple myeloma. [Abstract] Proceedings of the American Society of Clinical Oncology 20: A-1191, 2001.
Other Identifiers
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CAN-NCIC-MY7
Identifier Type: OTHER
Identifier Source: secondary_id
NCI-V95-0713
Identifier Type: OTHER
Identifier Source: secondary_id
CDR0000064328
Identifier Type: OTHER
Identifier Source: secondary_id
MY7
Identifier Type: -
Identifier Source: org_study_id
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