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

NCT00006890 | Completed Phase 2 DMC

• 4 other identifiers: MY9CAN-NCIC-MY9CELGENE-CAN-NCIC-MY9CDR0000068337
• Study Type: interventional
• Target: 67
• Locations: 2 countries
• Sites: 64

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.

Conditions

Multiple Myeloma and Plasma Cell Neoplasm

Keywords

refractory multiple myeloma; stage I multiple myeloma; stage II multiple myeloma; stage III multiple myeloma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Response rate

  2 years

• Time to progression

  2 years

• Overall survival

  8 years

Study Arms (1)

Prednisone plus Thalidomide

EXPERIMENTAL

After Autologous Stem Cell Infusion

Drug: prednisone; Drug: thalidomide

Interventions

prednisone DRUG

Prednisone 50mg on alternate days

Prednisone plus Thalidomide

thalidomide DRUG

THALIDOMIDE 200 mg qhs

Prednisone plus Thalidomide

Eligibility Criteria

• Age: 16 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• NCIC Clinical Trials Group: lead

Study Sites (64)

St. Mary's/Duluth Clinic Health System

Duluth, Minnesota, 55805, United States

Location

Tom Baker Cancer Center - Calgary

Calgary, Alberta, T2N 4N2, Canada

Location

Lethbridge Cancer Clinic

Lethbridge, Alberta, T1J 1W5, Canada

Location

Burnaby Hospital Regional Cancer Centre

Burnaby, British Columbia, V5H 4C2, Canada

Location

Nanaimo Cancer Clinic

Nanaimo, British Columbia, V9S 2B7, Canada

Location

Penticton Regional Hospital

Penticton, British Columbia, V2A 3G6, Canada

Location

British Columbia Cancer Agency - Fraser Valley Cancer Centre

Surrey, British Columbia, V3V 1Z2, Canada

Location

Prostate Centre at Vancouver General Hospital

Vancouver, British Columbia, V5Z 3J5, Canada

Location

British Columbia Cancer Agency

Vancouver, British Columbia, V5Z 4E6, Canada

Location

St. Paul's Hospital - Vancouver

Vancouver, British Columbia, V6Z 1Y6, Canada

Location

G. Steinhoff Clinical Research

Victoria, British Columbia, V8V 3N1, Canada

Location

Moncton Hospital

Moncton, New Brunswick, E1C 6ZB, Canada

Location

Doctor Leon Richard Oncology Centre

Moncton, New Brunswick, E1C 8X3, Canada

Location

Saint John Regional Hospital

Saint John, New Brunswick, E2L 4L2, Canada

Location

Newfoundland Cancer Treatment and Research Foundation

St. John's, Newfoundland and Labrador, A1B 3V6, Canada

Location

Nova Scotia Cancer Centre

Halifax, Nova Scotia, B3H 1V7, Canada

Location

Cape Breton Cancer Centre

Sydney, Nova Scotia, B1P 1PS, Canada

Location

Royal Victoria Hospital, Barrie

Barrie, Ontario, L4M 6M2, Canada

Location

William Osler Health Centre

Brampton, Ontario, L6W 2Z8, Canada

Location

Northeastern Ontario Regional Cancer Centre, Sudbury

Greater Sudbury, Ontario, P3E 5J1, Canada

Location

Hamilton and Disrict Urology Association

Hamilton, Ontario, L8N 1T8, Canada

Location

London Health Sciences Centre

London, Ontario, N6A 4G5, Canada

Location

Cancer Care Ontario-London Regional Cancer Centre

London, Ontario, N6A 4L6, Canada

Location

Markham Stouffville Hospital

Markham, Ontario, L3P 7T3, Canada

Location

Trillium Health Centre

Mississauga, Ontario, L5B 1B8, Canada

Location

Credit Valley Hospital

Mississauga, Ontario, L5M 2N1, Canada

Location

York County Hospital

Newmarket, Ontario, L3Y 2P9, Canada

Location

North York General Hospital, Ontario

North York, Ontario, M2E 1K1, Canada

Location

Male Health Centre/CMX Research Inc.

Oakville, Ontario, L6H 3PI, Canada

Location

Lakeridge Health Oshawa

Oshawa, Ontario, L1G 2B9, Canada

Location

Ottawa Regional Cancer Centre - General Campus

Ottawa, Ontario, K1H 1C4, Canada

Location

Ottawa Regional Cancer Center - General Division

Ottawa, Ontario, K1H 8L6, Canada

Location

Peterborough Oncology Clinic

Peterborough, Ontario, K9H 7B6, Canada

Location

Scarborough Hospital - General Site

Scarborough Village, Ontario, M1P 2V5, Canada

Location

Hotel Dieu Health Sciences Hospital - Niagara

St. Catharines, Ontario, L2R 5K3, Canada

Location

Northwestern Ontario Regional Cancer Centre, Thunder Bay

Thunder Bay, Ontario, P7A 7T1, Canada

Location

Toronto East General Hospital

Toronto, Ontario, M4C 3E7, Canada

Location

Toronto Sunnybrook Regional Cancer Centre

Toronto, Ontario, M4N 3M5, Canada

Location

St. Michael's Hospital - Toronto

Toronto, Ontario, M5B 1W8, Canada

Location

Mount Sinai Hospital - Toronto

Toronto, Ontario, M5G 1X5, Canada

Location

Toronto General Hospital

Toronto, Ontario, M5G 2C4, Canada

Location

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

Women's College Campus, Sunnybrook and Women's College Health Science Center

Toronto, Ontario, M5S 1B6, Canada

Location

Saint Joseph's Health Centre - Toronto

Toronto, Ontario, M6R 1B5, Canada

Location

Humber River Regional Hospital

Weston, Ontario, M9N 1N8, Canada

Location

Cancer Care Ontario - Windsor Regional Cancer Centre

Windsor, Ontario, N8W 2X3, Canada

Location

Queen Elizabeth Hospital, PEI

Charlottetown, Prince Edward Island, C1A 8T5, Canada

Location

CHUS-Hopital Fleurimont

Fleurimont, Quebec, J1H 5N4, Canada

Location

Hopital Charles Lemoyne

Greenfield Park, Quebec, J4V 2H1, Canada

Location

Centre Hospitalier Regional de Lanaudiere

Joliette, Quebec, J6E 6J2, Canada

Location

Maisonneuve-Rosemont Hospital

Montreal, Quebec, H1T 2M4, Canada

Location

McGill University

Montreal, Quebec, H2W 1S6, Canada

Location

Centre Hospitalier de l'Universite' de Montreal

Montreal, Quebec, H2W 1T8, Canada

Location

Hotel Dieu de Montreal

Montreal, Quebec, H2W 1T8, Canada

Location

Hopital Sainte Justine

Montreal, Quebec, H3T 1C5, Canada

Location

Hopital Du Sacre-Coeur de Montreal

Montreal, Quebec, H4J 1C5, Canada

Location

Kells Medical Research Group Inc.

Pointe-Claire, Quebec, H9R 4S3, Canada

Location

CHU de Quebec - L'Hotel-Dieu de Quebec

Québec, Quebec, G1R 2J6, Canada

Location

Hopital du Saint-Sacrament, Quebec

Québec, Quebec, G1S 4L8, Canada

Location

Centre Hospitalier Regional de Rimouski

Rimouski, Quebec, G5L 5T1, Canada

Location

L'Hopital Laval

Ste-Foy, Quebec, G1V 4G5, Canada

Location

Allan Blair Cancer Centre

Regina, Saskatchewan, S4T 7T1, Canada

Location

Saskatoon Cancer Centre

Saskatoon, Saskatchewan, S7N 4H4, Canada

Location

Lions Gate Hospital

North Vancouver, V7L 2P9, Canada

Location

Related Publications (2)

• Stewart AK, Chen CI, Howson-Jan K, White D, Roy J, Kovacs MJ, Shustik C, Sadura A, Shepherd L, Ding K, Meyer RM, Belch AR. Results of a multicenter randomized phase II trial of thalidomide and prednisone maintenance therapy for multiple myeloma after autologous stem cell transplant. Clin Cancer Res. 2004 Dec 15;10(24):8170-6. doi: 10.1158/1078-0432.CCR-04-1106.

  PMID: 15623591 RESULT

• 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 Oncology 21: A-1073, 2002.

  RESULT

MeSH Terms

Conditions

Multiple Myeloma; Neoplasms, Plasma Cell

Interventions

Prednisone; Thalidomide

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• A. Keith Stewart, MD

  Princess Margaret Hospital, Canada

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2000
• First Posted: March 8, 2004
• Study Start: July 12, 2000
• Primary Completion: May 3, 2002
• Study Completion: December 15, 2008
• Last Updated: April 2, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (63); US (1)