Combination Chemotherapy in Treating Patients With Multiple Myeloma
Comparative Study of Dexamethasone vs Prednisone (Both in Combination With Melphalan) as Induction Therapy in Untreated Symptomatic Myeloma With an Additional Assessment of Dexamethasone vs no Additional Treatment as Maintenance Therapy in Non-Progressing Patients
4 other identifiers
interventional
595
2 countries
37
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jun 1995
Longer than P75 for phase_3
37 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 2, 1995
CompletedFirst Submitted
Initial submission to the registry
November 1, 1999
CompletedFirst Posted
Study publicly available on registry
January 27, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 3, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
December 21, 2009
CompletedApril 2, 2020
March 1, 2020
8.9 years
November 1, 1999
March 31, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall survival
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
9 years
Secondary Outcomes (4)
Time to progression
9 years
Response rates
9 years
Toxicity
9 years
Quality of Life
9 years
Study Arms (2)
Melphan plus prednisone
ACTIVE COMPARATORmelphalan plus prednisone qd x 4 28 day cycles x 12 cycles; No treatment after stable response.
Melphan, prednisone pluse dexamethasone
ACTIVE COMPARATORmelphalan plus prednisone qd x 4 28 day cycles x 12 cycles; dexamethasone qd x 4 q 28 days after non-progression
Interventions
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.
9 mg/m2 daily for 4 days given orally on an empty stomach every 4 weeks
100 mg daily for 4 days given orally on a full stomach with each cycle of melphalan
Eligibility Criteria
Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.
Sponsors & Collaborators
Study Sites (37)
St. Mary's/Duluth Clinic Health System
Duluth, Minnesota, 55805, United States
Tom Baker Cancer Center - Calgary
Calgary, Alberta, T2N 4N2, Canada
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2, Canada
British Columbia Cancer Agency - Centre for the Southern Interior
Kelowna, British Columbia, V1Y 5L3, Canada
British Columbia Cancer Agency
Vancouver, British Columbia, V5Z 4E6, Canada
Providence Health Care - Vancouver
Vancouver, British Columbia, V6Z 1Y6, Canada
British Columbia Cancer Agency - Vancouver Island Cancer Centre
Victoria, British Columbia, V8R 6V5, Canada
Moncton Hospital
Moncton, New Brunswick, E1C 6ZB, Canada
Doctor Leon Richard Oncology Centre
Moncton, New Brunswick, E1C 8X3, Canada
Saint John Regional Hospital
Saint John, New Brunswick, E2L 4L2, Canada
Newfoundland Cancer Treatment and Research Foundation
St. John's, Newfoundland and Labrador, A1B 3V6, Canada
Nova Scotia Cancer Centre
Halifax, Nova Scotia, B3H 2Y9, Canada
William Osler Health Centre
Brampton, Ontario, L6W 2Z8, Canada
Northeastern Ontario Regional Cancer Centre, Sudbury
Greater Sudbury, Ontario, P3E 5J1, Canada
Cancer Care Ontario-Hamilton Regional Cancer Centre
Hamilton, Ontario, L8V 5C2, Canada
Kingston Regional Cancer Centre
Kingston, Ontario, K7L 5P9, Canada
Cancer Care Ontario-London Regional Cancer Centre
London, Ontario, N6A 4L6, Canada
Trillium Health Centre
Mississauga, Ontario, L5B 1B8, Canada
Credit Valley Hospital
Mississauga, Ontario, L5M 2N1, Canada
Southlake Regional Health Centre
Newmarket, Ontario, L3Y 2P9, Canada
Lakeridge Health Oshawa
Oshawa, Ontario, L1G 2B9, Canada
Algoma District Medical Group
Sault Ste. Marie, Ontario, P6B 1Y5, Canada
Hotel Dieu Health Sciences Hospital - Niagara
St. Catharines, Ontario, L2R 5K3, Canada
Toronto East General Hospital
Toronto, Ontario, M4C 3E7, Canada
Toronto Sunnybrook Regional Cancer Centre
Toronto, Ontario, M4N 3M5, Canada
St. Michael's Hospital - Toronto
Toronto, Ontario, M5B 1W8, Canada
Toronto General Hospital
Toronto, Ontario, M5G 2C4, Canada
Princess Margaret Hospital
Toronto, Ontario, M5G 2M9, Canada
Humber River Regional Hospital
Weston, Ontario, M9N 1N8, Canada
Cancer Care Ontario - Windsor Regional Cancer Centre
Windsor, Ontario, N8W 2X3, Canada
Queen Elizabeth Hospital, PEI
Charlottetown, Prince Edward Island, C1A 8T5, Canada
CHUS-Hopital Fleurimont
Fleurimont, Quebec, J1H 5N4, Canada
Hopital Charles Lemoyne
Greenfield Park, Quebec, J4V 2H1, Canada
McGill University
Montreal, Quebec, H2W 1S6, Canada
Hopital de L'Enfant Jesus
Québec, Quebec, G1J 1Z4, Canada
Hopital du Saint-Sacrement, Quebec
Québec, Quebec, G1S 4L8, Canada
Allan Blair Cancer Centre
Regina, Saskatchewan, S4T 7T1, Canada
Related Publications (3)
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.
PMID: 17233817RESULTShustik 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.
RESULTShustik 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.
RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Chaim Shustik, MD
Royal Victoria Hospital - Montreal
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 1, 1999
First Posted
January 27, 2003
Study Start
June 2, 1995
Primary Completion
May 3, 2004
Study Completion
December 21, 2009
Last Updated
April 2, 2020
Record last verified: 2020-03
Data Sharing
- IPD Sharing
- Will not share