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Sponsored by: |
National Cancer Institute of Canada |
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00002678 |
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.
Condition | Intervention | Phase |
Multiple Myeloma and Plasma Cell Neoplasm |
Drug: dexamethasone Drug: melphalan Drug: prednisone |
Phase III |
Genetics Home Reference related topics: | aceruloplasminemia hemophilia |
MedlinePlus related topics: | Cancer Multiple Myeloma |
ChemIDplus related topics: | Melphalan Dexamethasone Dexamethasone acetate Dexamethasone Sodium Phosphate Doxiproct plus Prednisone Melphalan hydrochloride Sarcolysin |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control |
Official Title: | A COMPARATIVE STUDY OF DEXAMETHASONE VERSUS PREDNISONE (BOTH IN COMBINATION WITH MELPHALAN) AS INDUCTION THERAPY IN UNTREATED SYMPTOMATIC MYELOMA WITH AN ADDITIONAL ASSESSMENT OF DEXAMETHASONE VERSUS NO ADDITIONAL TREATMENT AS MAINTENANCE THERAPY IN NON-PROGRESSING PATIENTS |
Estimated Enrollment: | 600 |
Study Start Date: | May 1995 |
OBJECTIVES:
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.
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:
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically proven previously untreated stage I-III multiple myeloma
Must meet at least 1 of the following conditions:
Detectable serum M-component of IgG, IgA, IgD, or IgE
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Show 37 Study Locations |
National Cancer Institute of Canada |
Study Chair: | Chaim Shustik, MD | Royal Victoria Hospital - Montreal |
Clinical trial summary from the National Cancer Institute's PDQ® database 
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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.
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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.
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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.
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Study ID Numbers: | CDR0000064328, CAN-NCIC-MY7, NCI-V95-0713 |
First Received: | November 1, 1999 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00002678 |
Health Authority: | United States: Federal Government |
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