Multiple Myeloma Clinical Trial

Thalidomide and Prednisone Following Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma

Summary

RATIONALE: Thalidomide may stop the growth of multiple myeloma by stopping blood flow to the tumor. Prednisone may be effective in preventing relapse of multiple myeloma.

PURPOSE: Randomized phase II trial to compare the effectiveness of two doses of thalidomide combined with prednisone following peripheral stem cell transplantation in treating patients who have multiple myeloma.

View Full Description

Full Description

OBJECTIVES: I. Determine which dose of thalidomide (200 mg vs 400 mg) combined with prednisone is the optimally tolerated dose when used as maintenance therapy following autologous stem cell transplantation in patients with multiple myeloma. II. Compare the response rate in patients treated with these regimens. III. Compare the progression-free and overall survival in patients treated with these regimens.

OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to age (60 and over vs under 60). Within 60-100 days after autologous stem cell transplantation, patients are randomized to 1 of 2 treatment arms. Arm I: Patients receive lower dose oral thalidomide daily and oral prednisone every other day. Arm II: Patients receive higher dose thalidomide daily and oral prednisone every other day. Treatment continues for 2 years in the absence of disease progression or unacceptable toxicity. Patients are followed monthly for 6 months, every 3 months, and then at time of disease progression.

PROJECTED ACCRUAL: A total of 40-80 patients (20-40 per arm) will be accrued for this study within 17-21 months.

View Eligibility Criteria

Eligibility Criteria

DISEASE CHARACTERISTICS: Histologically proven multiple myeloma Initial diagnosis must have been confirmed by one of the following prior to initial treatment for multiple myeloma: Biopsy of an osteolytic lesion or soft tissue tumor composed of plasma cells Bone marrow aspirate and/or biopsy demonstrating at least 10% plasmacytosis Bone marrow containing less than 10% plasma cells but with at least 1 bony lesion and the M-protein criteria outlined below Measurable serum M-component of IgG, IgA, IgD, or IgE at initial diagnosis OR If only light chain disease (urine M-protein only) present, then the urinary excretion of light chain (Bence Jones) protein must have been at least 1.0 g/24 hours at time of initial diagnosis Must have undergone autologous stem cell transplantation within 1 year of beginning initial chemotherapy for multiple myeloma Must be randomized 60-100 days after autologous stem cell infusion No evidence of progressive disease

PATIENT CHARACTERISTICS: Age: 16 and over Performance status: ECOG 0-2 Life expectancy: At least 6 months Hematopoietic: See Disease Characteristics Granulocyte count at least 1,000/mm3 Platelet count at least 100,000/mm3 Hepatic: AST and/or ALT no greater than 1.5 times upper limit of normal (ULN) Alkaline phosphatase no greater than 1.5 times ULN Renal: Creatinine no greater than 3 times ULN Cardiovascular: No uncontrolled hypertension Other: Not pregnant or nursing Negative pregnancy test Fertile female patients must use 2 effective methods of contraception (1 barrier and 1 hormonal) during and for 1 month after study Fertile male patients must use effective barrier contraception during and for 1 month after study No other medical condition that would preclude long term use of prednisone or thalidomide No other malignancy within the past 5 years except adequately treated squamous cell or basal cell skin cancer or carcinoma in situ of the cervix No diabetes with end stage organ damage No history of gastric ulceration or bleeding No avascular necrosis of the hips No peripheral neuropathy causing symptomatic dysfunction Sensory symptoms induced by vincristine allowed No demonstrated hypersensitivity to thalidomide or its components No other major medical illness that would increase risk or preclude study No employment that prohibits the use of sedatives (due to known effect of thalidomide)

PRIOR CONCURRENT THERAPY: Biologic: See Disease Characteristics No prior thalidomide Chemotherapy: See Disease Characteristics Endocrine: Not specified Radiotherapy: Not specified Surgery: Not specified Other: No other concurrent anticancer treatment No other concurrent investigational therapy

Study is for people with:

Multiple Myeloma

Phase:

Phase 2

Estimated Enrollment:

67

Study ID:

NCT00006890

Recruitment Status:

Completed

Sponsor:

NCIC Clinical Trials Group

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 60 Locations for this study

See Locations Near You

St. Mary's/Duluth Clinic Health System
Duluth Minnesota, 55805, United States
Tom Baker Cancer Center - Calgary
Calgary Alberta, T2N 4, Canada
Lethbridge Cancer Clinic
Lethbridge Alberta, T1J 1, Canada
Burnaby Hospital Regional Cancer Centre
Burnaby British Columbia, V5H 4, Canada
Nanaimo Cancer Clinic
Nanaimo British Columbia, V9S 2, Canada
Penticton Regional Hospital
Penticton British Columbia, V2A 3, Canada
British Columbia Cancer Agency - Fraser Valley Cancer Centre
Surrey British Columbia, V3V 1, Canada
Prostate Centre at Vancouver General Hospital
Vancouver British Columbia, V5Z 3, Canada
British Columbia Cancer Agency
Vancouver British Columbia, V5Z 4, Canada
St. Paul's Hospital - Vancouver
Vancouver British Columbia, V6Z 1, Canada
G. Steinhoff Clinical Research
Victoria British Columbia, V8V 3, Canada
Moncton Hospital
Moncton New Brunswick, E1C 6, Canada
Doctor Leon Richard Oncology Centre
Moncton New Brunswick, E1C 8, Canada
Saint John Regional Hospital
Saint John New Brunswick, E2L 4, Canada
Newfoundland Cancer Treatment and Research Foundation
St. Johns Newfoundland and Labrador, A1B 3, Canada
Nova Scotia Cancer Centre
Halifax Nova Scotia, B3H 1, Canada
Cape Breton Cancer Centre
Sydney Nova Scotia, B1P 1, Canada
Royal Victoria Hospital, Barrie
Barrie Ontario, L4M 6, Canada
William Osler Health Centre
Brampton Ontario, L6W 2, Canada
Hamilton and Disrict Urology Association
Hamilton Ontario, L8N 1, Canada
London Health Sciences Centre
London Ontario, N6A 4, Canada
Cancer Care Ontario-London Regional Cancer Centre
London Ontario, N6A 4, Canada
Markham Stouffville Hospital
Markham Ontario, L3P 7, Canada
Trillium Health Centre
Mississauga Ontario, L5B 1, Canada
Credit Valley Hospital
Mississauga Ontario, L5M 2, Canada
York County Hospital
Newmarket Ontario, L3Y 2, Canada
North York General Hospital, Ontario
North York Ontario, M2E 1, Canada
Male Health Centre/CMX Research Inc.
Oakville Ontario, L6H 3, Canada
Lakeridge Health Oshawa
Oshawa Ontario, L1G 2, Canada
Ottawa Regional Cancer Centre - General Campus
Ottawa Ontario, K1H 1, Canada
Ottawa Regional Cancer Center - General Division
Ottawa Ontario, K1H 8, Canada
Peterborough Oncology Clinic
Peterborough Ontario, K9H 7, Canada
Scarborough Hospital - General Site
Scarborough Ontario, M1P 2, Canada
Hotel Dieu Health Sciences Hospital - Niagara
St. Catharines Ontario, L2R 5, Canada
Northeastern Ontario Regional Cancer Centre, Sudbury
Sudbury Ontario, P3E 5, Canada
Northwestern Ontario Regional Cancer Centre, Thunder Bay
Thunder Bay Ontario, P7A 7, Canada
Toronto East General Hospital
Toronto Ontario, M4C 3, Canada
Toronto Sunnybrook Regional Cancer Centre
Toronto Ontario, M4N 3, Canada
St. Michael's Hospital - Toronto
Toronto Ontario, M5B 1, Canada
Mount Sinai Hospital - Toronto
Toronto Ontario, M5G 1, Canada
Toronto General Hospital
Toronto Ontario, M5G 2, Canada
Princess Margaret Hospital
Toronto Ontario, M5G 2, Canada
Women's College Campus, Sunnybrook and Women's College Health Science Center
Toronto Ontario, M5S 1, Canada
Saint Joseph's Health Centre - Toronto
Toronto Ontario, M6R 1, Canada
Humber River Regional Hospital
Weston Ontario, M9N 1, Canada
Cancer Care Ontario - Windsor Regional Cancer Centre
Windsor Ontario, N8W 2, Canada
Queen Elizabeth Hospital, PEI
Charlottetown Prince Edward Island, C1A 8, Canada
CHUS-Hopital Fleurimont
Fleurimont Quebec, J1H 5, Canada
Hopital Charles Lemoyne
Greenfield Park Quebec, J4V 2, Canada
Centre Hospitalier Regional de Lanaudiere
Joliette Quebec, J6E 6, Canada
Maisonneuve-Rosemont Hospital
Montreal Quebec, H1T 2, Canada
McGill University
Montreal Quebec, H2W 1, Canada
Centre Hospitalier de l'Universite' de Montreal
Montreal Quebec, H2W 1, Canada
Hotel Dieu de Montreal
Montreal Quebec, H2W 1, Canada
Hopital Sainte Justine
Montreal Quebec, H3T 1, Canada
Hopital Du Sacre-Coeur de Montreal
Montreal Quebec, H4J 1, Canada
Kells Medical Research Group Inc.
Pointe Claire Quebec, H9R 4, Canada
CHU de Quebec - L'Hotel-Dieu de Quebec
Quebec City Quebec, G1R 2, Canada
Hopital du Saint-Sacrament, Quebec
Quebec City Quebec, G1S 4, Canada
Centre Hospitalier Regional de Rimouski
Rimouski Quebec, G5L 5, Canada
L'Hopital Laval
Ste-Foy Quebec, G1V 4, Canada
Allan Blair Cancer Centre
Regina Saskatchewan, S4T 7, Canada
Saskatoon Cancer Centre
Saskatoon Saskatchewan, S7N 4, Canada
Lions Gate Hospital
North Vancouver , V7L 2, Canada

How clear is this clinincal trial information?

Study is for people with:

Multiple Myeloma

Phase:

Phase 2

Estimated Enrollment:

67

Study ID:

NCT00006890

Recruitment Status:

Completed

Sponsor:


NCIC Clinical Trials Group

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.

Please confirm you are a US based health care provider:

Yes, I am a health care Provider No, I am not a health care provider