Thalidomide and Prednisone Following Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma
Study Details
Study Description
Brief 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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 2 |
Detailed 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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Prednisone plus Thalidomide After Autologous Stem Cell Infusion |
Drug: prednisone
Prednisone 50mg on alternate days
Drug: thalidomide
THALIDOMIDE 200 mg qhs
|
Outcome Measures
Primary Outcome Measures
- incidence of drop-out or dose reduction [2 years]
incidence of drop-out or dose reduction due to toxicity within 6 months from the start of treatment.
Secondary Outcome Measures
- Response rate [2 years]
- Time to progression [2 years]
- Overall survival [8 years]
Eligibility Criteria
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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | St. Mary's/Duluth Clinic Health System | Duluth | Minnesota | United States | 55805 |
2 | Tom Baker Cancer Center - Calgary | Calgary | Alberta | Canada | T2N 4N2 |
3 | Lethbridge Cancer Clinic | Lethbridge | Alberta | Canada | T1J 1W5 |
4 | Burnaby Hospital Regional Cancer Centre | Burnaby | British Columbia | Canada | V5H 4C2 |
5 | Nanaimo Cancer Clinic | Nanaimo | British Columbia | Canada | V9S 2B7 |
6 | Penticton Regional Hospital | Penticton | British Columbia | Canada | V2A 3G6 |
7 | British Columbia Cancer Agency - Fraser Valley Cancer Centre | Surrey | British Columbia | Canada | V3V 1Z2 |
8 | Prostate Centre at Vancouver General Hospital | Vancouver | British Columbia | Canada | V5Z 3J5 |
9 | British Columbia Cancer Agency | Vancouver | British Columbia | Canada | V5Z 4E6 |
10 | St. Paul's Hospital - Vancouver | Vancouver | British Columbia | Canada | V6Z 1Y6 |
11 | G. Steinhoff Clinical Research | Victoria | British Columbia | Canada | V8V 3N1 |
12 | Moncton Hospital | Moncton | New Brunswick | Canada | E1C 6ZB |
13 | Doctor Leon Richard Oncology Centre | Moncton | New Brunswick | Canada | E1C 8X3 |
14 | Saint John Regional Hospital | Saint John | New Brunswick | Canada | E2L 4L2 |
15 | Newfoundland Cancer Treatment and Research Foundation | St. Johns | Newfoundland and Labrador | Canada | A1B 3V6 |
16 | Nova Scotia Cancer Centre | Halifax | Nova Scotia | Canada | B3H 1V7 |
17 | Cape Breton Cancer Centre | Sydney | Nova Scotia | Canada | B1P 1PS |
18 | Royal Victoria Hospital, Barrie | Barrie | Ontario | Canada | L4M 6M2 |
19 | William Osler Health Centre | Brampton | Ontario | Canada | L6W 2Z8 |
20 | Hamilton and Disrict Urology Association | Hamilton | Ontario | Canada | L8N 1T8 |
21 | London Health Sciences Centre | London | Ontario | Canada | N6A 4G5 |
22 | Cancer Care Ontario-London Regional Cancer Centre | London | Ontario | Canada | N6A 4L6 |
23 | Markham Stouffville Hospital | Markham | Ontario | Canada | L3P 7T3 |
24 | Trillium Health Centre | Mississauga | Ontario | Canada | L5B 1B8 |
25 | Credit Valley Hospital | Mississauga | Ontario | Canada | L5M 2N1 |
26 | York County Hospital | Newmarket | Ontario | Canada | L3Y 2P9 |
27 | North York General Hospital, Ontario | North York | Ontario | Canada | M2E 1K1 |
28 | Male Health Centre/CMX Research Inc. | Oakville | Ontario | Canada | L6H 3PI |
29 | Lakeridge Health Oshawa | Oshawa | Ontario | Canada | L1G 2B9 |
30 | Ottawa Regional Cancer Centre - General Campus | Ottawa | Ontario | Canada | K1H 1C4 |
31 | Ottawa Regional Cancer Center - General Division | Ottawa | Ontario | Canada | K1H 8L6 |
32 | Peterborough Oncology Clinic | Peterborough | Ontario | Canada | K9H 7B6 |
33 | Scarborough Hospital - General Site | Scarborough | Ontario | Canada | M1P 2V5 |
34 | Hotel Dieu Health Sciences Hospital - Niagara | St. Catharines | Ontario | Canada | L2R 5K3 |
35 | Northeastern Ontario Regional Cancer Centre, Sudbury | Sudbury | Ontario | Canada | P3E 5J1 |
36 | Northwestern Ontario Regional Cancer Centre, Thunder Bay | Thunder Bay | Ontario | Canada | P7A 7T1 |
37 | Toronto East General Hospital | Toronto | Ontario | Canada | M4C 3E7 |
38 | Toronto Sunnybrook Regional Cancer Centre | Toronto | Ontario | Canada | M4N 3M5 |
39 | St. Michael's Hospital - Toronto | Toronto | Ontario | Canada | M5B 1W8 |
40 | Mount Sinai Hospital - Toronto | Toronto | Ontario | Canada | M5G 1X5 |
41 | Toronto General Hospital | Toronto | Ontario | Canada | M5G 2C4 |
42 | Princess Margaret Hospital | Toronto | Ontario | Canada | M5G 2M9 |
43 | Women's College Campus, Sunnybrook and Women's College Health Science Center | Toronto | Ontario | Canada | M5S 1B6 |
44 | Saint Joseph's Health Centre - Toronto | Toronto | Ontario | Canada | M6R 1B5 |
45 | Humber River Regional Hospital | Weston | Ontario | Canada | M9N 1N8 |
46 | Cancer Care Ontario - Windsor Regional Cancer Centre | Windsor | Ontario | Canada | N8W 2X3 |
47 | Queen Elizabeth Hospital, PEI | Charlottetown | Prince Edward Island | Canada | C1A 8T5 |
48 | CHUS-Hopital Fleurimont | Fleurimont | Quebec | Canada | J1H 5N4 |
49 | Hopital Charles Lemoyne | Greenfield Park | Quebec | Canada | J4V 2H1 |
50 | Centre Hospitalier Regional de Lanaudiere | Joliette | Quebec | Canada | J6E 6J2 |
51 | Maisonneuve-Rosemont Hospital | Montreal | Quebec | Canada | H1T 2M4 |
52 | McGill University | Montreal | Quebec | Canada | H2W 1S6 |
53 | Centre Hospitalier de l'Universite' de Montreal | Montreal | Quebec | Canada | H2W 1T8 |
54 | Hotel Dieu de Montreal | Montreal | Quebec | Canada | H2W 1T8 |
55 | Hopital Sainte Justine | Montreal | Quebec | Canada | H3T 1C5 |
56 | Hopital Du Sacre-Coeur de Montreal | Montreal | Quebec | Canada | H4J 1C5 |
57 | Kells Medical Research Group Inc. | Pointe Claire | Quebec | Canada | H9R 4S3 |
58 | CHU de Quebec - L'Hotel-Dieu de Quebec | Quebec City | Quebec | Canada | G1R 2J6 |
59 | Hopital du Saint-Sacrament, Quebec | Quebec City | Quebec | Canada | G1S 4L8 |
60 | Centre Hospitalier Regional de Rimouski | Rimouski | Quebec | Canada | G5L 5T1 |
61 | L'Hopital Laval | Ste-Foy | Quebec | Canada | G1V 4G5 |
62 | Allan Blair Cancer Centre | Regina | Saskatchewan | Canada | S4T 7T1 |
63 | Saskatoon Cancer Centre | Saskatoon | Saskatchewan | Canada | S7N 4H4 |
64 | Lions Gate Hospital | North Vancouver | Canada | V7L 2P9 |
Sponsors and Collaborators
- NCIC Clinical Trials Group
Investigators
- Study Chair: A. Keith Stewart, MD, Princess Margaret Hospital, Canada
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- MY9
- CAN-NCIC-MY9
- CELGENE-CAN-NCIC-MY9
- CDR0000068337