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| Sponsor: | NCIC Clinical Trials Group |
|---|---|
| Collaborators: |
National Cancer Institute (NCI) Eastern Cooperative Oncology Group |
| Information provided by (Responsible Party): | NCIC Clinical Trials Group |
| ClinicalTrials.gov Identifier: | NCT00049673 |
Purpose
RATIONALE: Thalidomide may stop the growth of multiple myeloma by stopping blood flow to the tumor. It is not yet known whether combining thalidomide with prednisone and giving them after autologous stem cell transplantation may be effective in treating multiple myeloma.
PURPOSE: This randomized phase III trial is studying thalidomide and prednisone to see how well they work compared to observation in treating patients who have undergone stem cell transplantation for multiple myeloma.
| Condition | Intervention | Phase |
|---|---|---|
|
Multiple Myeloma and Plasma Cell Neoplasm |
Drug: prednisone Drug: thalidomide Other: clinical observation |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Randomized Phase III Study Of Thalidomide And Prednisone As Maintenance Therapy Following Autologous Stem Cell Transplant in Patients With Multiple Myeloma |
| Enrollment: | 332 |
| Study Start Date: | September 2002 |
| Estimated Study Completion Date: | June 2013 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm I
Patients receive oral thalidomide daily and oral prednisone every other day for 4 years in the absence of disease progression or unacceptable toxicity.
|
Drug: prednisone
Given orally
Drug: thalidomide
Given orally
|
|
No Intervention: Arm II
Patients undergo observation.
|
Other: clinical observation
No intervention
|
OBJECTIVES:
OUTLINE: This is a randomized, non-blinded, multicenter study. Patients are stratified according to treatment center, age (under 60 vs 60 and over), and response to prior transplantation (complete vs incomplete). Patients are randomized to 1 of 2 treatment arms.
For both arms, patients are assessed (including for quality of life) regularly throughout the treatment/observation period: at baseline, every 2 months for 6 months, every 3 months for up to 4 years, every 6 months for 1 year, and then annually thereafter.
After the treatment/observation period, patients are followed every 6 months for 1 year and then annually thereafter.
PROJECTED ACCRUAL: A total of 324 patients will be accrued for this study within 3.5 years.
Eligibility| Ages Eligible for Study: | 16 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed multiple myeloma as evidenced by one of the following:
Previously treated with autologous stem cell transplantation after high-dose melphalan (200 mg/m^2) within the past 60-100 days
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
No prior spontaneous deep vein thrombosis within the past 5 years
Pulmonary
Other
No diabetes with end-organ damage defined as:
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Contacts and Locations| Canada, Alberta | |
| Tom Baker Cancer Centre | |
| Calgary, Alberta, Canada, T2N 4N2 | |
| Cross Cancer Institute | |
| Edmonton, Alberta, Canada, T6G 1Z2 | |
| Canada, British Columbia | |
| BCCA - Vancouver Cancer Centre | |
| Vancouver, British Columbia, Canada, V5Z 4E6 | |
| Canada, Manitoba | |
| CancerCare Manitoba | |
| Winnipeg, Manitoba, Canada, R3E 0V9 | |
| Canada, New Brunswick | |
| The Moncton Hospital | |
| Moncton, New Brunswick, Canada, E1C 6Z8 | |
| Atlantic Health Sciences Corporation | |
| Saint John, New Brunswick, Canada, E2L 4L2 | |
| Canada, Newfoundland and Labrador | |
| Dr. H. Bliss Murphy Cancer Centre | |
| St. John's, Newfoundland and Labrador, Canada, AIB 3V6 | |
| Canada, Nova Scotia | |
| QEII Health Sciences Center | |
| Halifax, Nova Scotia, Canada, B3H 1V7 | |
| Canada, Ontario | |
| Juravinski Cancer Centre at Hamilton Health Sciences | |
| Hamilton, Ontario, Canada, L8V 5C2 | |
| Cancer Centre of Southeastern Ontario at Kingston | |
| Kingston, Ontario, Canada, K7L 5P9 | |
| London Regional Cancer Program | |
| London, Ontario, Canada, N6A 4L6 | |
| Odette Cancer Centre | |
| Toronto, Ontario, Canada, M4N 3M5 | |
| Univ. Health Network-Princess Margaret Hospital | |
| Toronto, Ontario, Canada, M5G 2M9 | |
| Canada, Quebec | |
| McGill University - Dept. Oncology | |
| Montreal, Quebec, Canada, H2W 1S6 | |
| Hopital Maisonneuve-Rosemont | |
| Montreal, Quebec, Canada, H1T 2M4 | |
| CHA-Hopital Du St-Sacrement | |
| Quebec City, Quebec, Canada, G1S 4L8 | |
| Centre hospitalier universitaire de Sherbrooke | |
| Sherbrooke, Quebec, Canada, J1H 5N4 | |
| Canada, Saskatchewan | |
| Saskatoon Cancer Centre | |
| Saskatoon, Saskatchewan, Canada, S7N 4H4 | |
| Study Chair: | A. Keith Stewart, MD | Mayo Clinic |
| Study Chair: | Martha Q. Lacy, MD | Mayo Clinic |
More Information
| Responsible Party: | NCIC Clinical Trials Group |
| ClinicalTrials.gov Identifier: | NCT00049673 History of Changes |
| Other Study ID Numbers: | MY10, CAN-NCIC-MY10, CAN-NCIC-JMY10, ECOG-NCIC-JMY10, CELGENE-CAN-NCIC-MY10, CDR0000258158 |
| Study First Received: | November 12, 2002 |
| Last Updated: | October 28, 2011 |
| Health Authority: | Canada: Health Canada |
|
stage I multiple myeloma stage II multiple myeloma stage III multiple myeloma |
|
Neoplasms Multiple Myeloma Neoplasms, Plasma Cell Plasmacytoma Neoplasms by Histologic Type Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders Lymphoproliferative Disorders Immunoproliferative Disorders Immune System Diseases |
Prednisone Thalidomide Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions Antineoplastic Agents, Hormonal Antineoplastic Agents Therapeutic Uses Anti-Inflammatory Agents Immunosuppressive Agents Immunologic Factors Leprostatic Agents Anti-Bacterial Agents |