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

Multiple Myeloma and Plasma Cell Neoplasm Clinical Trial

Official title:

A Randomized Phase II Dose Finding Study Of Thalidomide And Prednisone As Maintenance Therapy Following Autologous Stem Cell Transplant In Patients With Multiple Myeloma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00006890
• Other study ID #: MY9
• Secondary ID: CAN-NCIC-MY9CELG
• Status: Completed
• Phase: Phase 2
• Start date: July 12, 2000
• Est. completion date: December 15, 2008

Study information

• Verified date: March 2020
• Source: Canadian Cancer Trials Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: December 15, 2008
• Est. primary completion date: May 3, 2002
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Myeloma
• Multiple Myeloma and Plasma Cell Neoplasm
• Neoplasms, Plasma Cell
• Plasmacytoma

Intervention

Drug:
• prednisone
Prednisone 50mg on alternate days
• thalidomide
THALIDOMIDE 200 mg qhs

Locations

Country	Name	City	State
Canada	Royal Victoria Hospital, Barrie	Barrie	Ontario
Canada	William Osler Health Centre	Brampton	Ontario
Canada	Burnaby Hospital Regional Cancer Centre	Burnaby	British Columbia
Canada	Tom Baker Cancer Center - Calgary	Calgary	Alberta
Canada	Queen Elizabeth Hospital, PEI	Charlottetown	Prince Edward Island
Canada	CHUS-Hopital Fleurimont	Fleurimont	Quebec
Canada	Hopital Charles Lemoyne	Greenfield Park	Quebec
Canada	Nova Scotia Cancer Centre	Halifax	Nova Scotia
Canada	Hamilton and Disrict Urology Association	Hamilton	Ontario
Canada	Centre Hospitalier Regional de Lanaudiere	Joliette	Quebec
Canada	Lethbridge Cancer Clinic	Lethbridge	Alberta
Canada	Cancer Care Ontario-London Regional Cancer Centre	London	Ontario
Canada	London Health Sciences Centre	London	Ontario
Canada	Markham Stouffville Hospital	Markham	Ontario
Canada	Credit Valley Hospital	Mississauga	Ontario
Canada	Trillium Health Centre	Mississauga	Ontario
Canada	Doctor Leon Richard Oncology Centre	Moncton	New Brunswick
Canada	Moncton Hospital	Moncton	New Brunswick
Canada	Centre Hospitalier de l'Universite' de Montreal	Montreal	Quebec
Canada	Hopital Du Sacre-Coeur de Montreal	Montreal	Quebec
Canada	Hopital Sainte Justine	Montreal	Quebec
Canada	Hotel Dieu de Montreal	Montreal	Quebec
Canada	Maisonneuve-Rosemont Hospital	Montreal	Quebec
Canada	McGill University	Montreal	Quebec
Canada	Nanaimo Cancer Clinic	Nanaimo	British Columbia
Canada	York County Hospital	Newmarket	Ontario
Canada	Lions Gate Hospital	North Vancouver
Canada	North York General Hospital, Ontario	North York	Ontario
Canada	Male Health Centre/CMX Research Inc.	Oakville	Ontario
Canada	Lakeridge Health Oshawa	Oshawa	Ontario
Canada	Ottawa Regional Cancer Center - General Division	Ottawa	Ontario
Canada	Ottawa Regional Cancer Centre - General Campus	Ottawa	Ontario
Canada	Penticton Regional Hospital	Penticton	British Columbia
Canada	Peterborough Oncology Clinic	Peterborough	Ontario
Canada	Kells Medical Research Group Inc.	Pointe Claire	Quebec
Canada	CHU de Quebec - L'Hotel-Dieu de Quebec	Quebec City	Quebec
Canada	Hopital du Saint-Sacrament, Quebec	Quebec City	Quebec
Canada	Allan Blair Cancer Centre	Regina	Saskatchewan
Canada	Centre Hospitalier Regional de Rimouski	Rimouski	Quebec
Canada	Saint John Regional Hospital	Saint John	New Brunswick
Canada	Saskatoon Cancer Centre	Saskatoon	Saskatchewan
Canada	Scarborough Hospital - General Site	Scarborough	Ontario
Canada	Hotel Dieu Health Sciences Hospital - Niagara	St. Catharines	Ontario
Canada	Newfoundland Cancer Treatment and Research Foundation	St. Johns	Newfoundland and Labrador
Canada	L'Hopital Laval	Ste-Foy	Quebec
Canada	Northeastern Ontario Regional Cancer Centre, Sudbury	Sudbury	Ontario
Canada	British Columbia Cancer Agency - Fraser Valley Cancer Centre	Surrey	British Columbia
Canada	Cape Breton Cancer Centre	Sydney	Nova Scotia
Canada	Northwestern Ontario Regional Cancer Centre, Thunder Bay	Thunder Bay	Ontario
Canada	Mount Sinai Hospital - Toronto	Toronto	Ontario
Canada	Princess Margaret Hospital	Toronto	Ontario
Canada	Saint Joseph's Health Centre - Toronto	Toronto	Ontario
Canada	St. Michael's Hospital - Toronto	Toronto	Ontario
Canada	Toronto East General Hospital	Toronto	Ontario
Canada	Toronto General Hospital	Toronto	Ontario
Canada	Toronto Sunnybrook Regional Cancer Centre	Toronto	Ontario
Canada	Women's College Campus, Sunnybrook and Women's College Health Science Center	Toronto	Ontario
Canada	British Columbia Cancer Agency	Vancouver	British Columbia
Canada	Prostate Centre at Vancouver General Hospital	Vancouver	British Columbia
Canada	St. Paul's Hospital - Vancouver	Vancouver	British Columbia
Canada	G. Steinhoff Clinical Research	Victoria	British Columbia
Canada	Humber River Regional Hospital	Weston	Ontario
Canada	Cancer Care Ontario - Windsor Regional Cancer Centre	Windsor	Ontario
United States	St. Mary's/Duluth Clinic Health System	Duluth	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
NCIC Clinical Trials Group

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (2)

Stewart KA, Chen C, Howson-Jan K, et al.: A randomized phase II dose-finding trial of thalidomide and prednisone as maintenance therapy for myeloma following autologous stem cell transplant. [Abstract] Proceedings of the American Society of Clinical Oncol

Stewart KA, Chen C, Howson-Jan K, et al.: Results of a multi-center randomized phase II trial of thalidomide and prednisone maintenance therapy for multiple myeloma following autologous stem cell transplant. [Abstract] Blood 104 (11 Pt 1): A-335, 2004.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence of drop-out or dose reduction	incidence of drop-out or dose reduction due to toxicity within 6 months from the start of treatment.	2 years
Secondary	Response rate		2 years
Secondary	Time to progression		2 years
Secondary	Overall survival		8 years