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

March 31, 2020 updated by: NCIC Clinical Trials Group

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

67

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • North Vancouver, Canada, V7L 2P9
        • Lions Gate Hospital
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N2
        • Tom Baker Cancer Center - Calgary
      • Lethbridge, Alberta, Canada, T1J 1W5
        • Lethbridge Cancer Clinic
    • British Columbia
      • Burnaby, British Columbia, Canada, V5H 4C2
        • Burnaby Hospital Regional Cancer Centre
      • Nanaimo, British Columbia, Canada, V9S 2B7
        • Nanaimo Cancer Clinic
      • Penticton, British Columbia, Canada, V2A 3G6
        • Penticton Regional Hospital
      • Surrey, British Columbia, Canada, V3V 1Z2
        • British Columbia Cancer Agency - Fraser Valley Cancer Centre
      • Vancouver, British Columbia, Canada, V5Z 3J5
        • Prostate Centre at Vancouver General Hospital
      • Vancouver, British Columbia, Canada, V6Z 1Y6
        • St. Paul's Hospital - Vancouver
      • Vancouver, British Columbia, Canada, V5Z 4E6
        • British Columbia Cancer Agency
      • Victoria, British Columbia, Canada, V8V 3N1
        • G. Steinhoff Clinical Research
    • New Brunswick
      • Moncton, New Brunswick, Canada, E1C 6ZB
        • Moncton Hospital
      • Moncton, New Brunswick, Canada, E1C 8X3
        • Doctor Leon Richard Oncology Centre
      • Saint John, New Brunswick, Canada, E2L 4L2
        • Saint John Regional Hospital
    • Newfoundland and Labrador
      • St. Johns, Newfoundland and Labrador, Canada, A1B 3V6
        • Newfoundland Cancer Treatment and Research Foundation
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 1V7
        • Nova Scotia Cancer Centre
      • Sydney, Nova Scotia, Canada, B1P 1PS
        • Cape Breton Cancer Centre
    • Ontario
      • Barrie, Ontario, Canada, L4M 6M2
        • Royal Victoria Hospital, Barrie
      • Brampton, Ontario, Canada, L6W 2Z8
        • William Osler Health Centre
      • Hamilton, Ontario, Canada, L8N 1T8
        • Hamilton and Disrict Urology Association
      • London, Ontario, Canada, N6A 4G5
        • London Health Sciences Centre
      • London, Ontario, Canada, N6A 4L6
        • Cancer Care Ontario-London Regional Cancer Centre
      • Markham, Ontario, Canada, L3P 7T3
        • Markham Stouffville Hospital
      • Mississauga, Ontario, Canada, L5B 1B8
        • Trillium Health Centre
      • Mississauga, Ontario, Canada, L5M 2N1
        • Credit Valley Hospital
      • Newmarket, Ontario, Canada, L3Y 2P9
        • York County Hospital
      • North York, Ontario, Canada, M2E 1K1
        • North York General Hospital, Ontario
      • Oakville, Ontario, Canada, L6H 3PI
        • Male Health Centre/CMX Research Inc.
      • Oshawa, Ontario, Canada, L1G 2B9
        • Lakeridge Health Oshawa
      • Ottawa, Ontario, Canada, K1H 8L6
        • Ottawa Regional Cancer Center - General Division
      • Ottawa, Ontario, Canada, K1H 1C4
        • Ottawa Regional Cancer Centre - General Campus
      • Peterborough, Ontario, Canada, K9H 7B6
        • Peterborough Oncology Clinic
      • Scarborough, Ontario, Canada, M1P 2V5
        • Scarborough Hospital - General Site
      • St. Catharines, Ontario, Canada, L2R 5K3
        • Hotel Dieu Health Sciences Hospital - Niagara
      • Sudbury, Ontario, Canada, P3E 5J1
        • Northeastern Ontario Regional Cancer Centre, Sudbury
      • Thunder Bay, Ontario, Canada, P7A 7T1
        • Northwestern Ontario Regional Cancer Centre, Thunder Bay
      • Toronto, Ontario, Canada, M5G 2C4
        • Toronto General Hospital
      • Toronto, Ontario, Canada, M4C 3E7
        • Toronto East General Hospital
      • Toronto, Ontario, Canada, M4N 3M5
        • Toronto Sunnybrook Regional Cancer Centre
      • Toronto, Ontario, Canada, M5B 1W8
        • St. Michael's Hospital - Toronto
      • Toronto, Ontario, Canada, M5G 1X5
        • Mount Sinai Hospital - Toronto
      • Toronto, Ontario, Canada, M5G 2M9
        • Princess Margaret Hospital
      • Toronto, Ontario, Canada, M5S 1B6
        • Women's College Campus, Sunnybrook and Women's College Health Science Center
      • Toronto, Ontario, Canada, M6R 1B5
        • Saint Joseph's Health Centre - Toronto
      • Weston, Ontario, Canada, M9N 1N8
        • Humber River Regional Hospital
      • Windsor, Ontario, Canada, N8W 2X3
        • Cancer Care Ontario - Windsor Regional Cancer Centre
    • Prince Edward Island
      • Charlottetown, Prince Edward Island, Canada, C1A 8T5
        • Queen Elizabeth Hospital, PEI
    • Quebec
      • Fleurimont, Quebec, Canada, J1H 5N4
        • CHUS-Hopital Fleurimont
      • Greenfield Park, Quebec, Canada, J4V 2H1
        • Hôpital Charles LeMoyne
      • Joliette, Quebec, Canada, J6E 6J2
        • Centre hospitalier régional de Lanaudière
      • Montreal, Quebec, Canada, H2W 1S6
        • McGill University
      • Montreal, Quebec, Canada, H1T 2M4
        • Maisonneuve-Rosemont Hospital
      • Montreal, Quebec, Canada, H2W 1T8
        • Centre Hospitalier de l'Universite' de Montreal
      • Montreal, Quebec, Canada, H2W 1T8
        • Hotel Dieu de Montreal
      • Montreal, Quebec, Canada, H4J 1C5
        • Hopital Du Sacre-Coeur de Montreal
      • Montreal, Quebec, Canada, H3T 1C5
        • Hôpital Sainte Justine
      • Pointe Claire, Quebec, Canada, H9R 4S3
        • Kells Medical Research Group Inc.
      • Quebec City, Quebec, Canada, G1S 4L8
        • Hopital du Saint-Sacrament, Quebec
      • Quebec City, Quebec, Canada, G1R 2J6
        • CHU de Quebec - L'Hotel-Dieu de Quebec
      • Rimouski, Quebec, Canada, G5L 5T1
        • Centre Hospitalier Regional De Rimouski
      • Ste-Foy, Quebec, Canada, G1V 4G5
        • L'Hopital Laval
    • Saskatchewan
      • Regina, Saskatchewan, Canada, S4T 7T1
        • Allan Blair Cancer Centre
      • Saskatoon, Saskatchewan, Canada, S7N 4H4
        • Saskatoon Cancer Centre
  • United States
    • Minnesota
      • Duluth, Minnesota, United States, 55805
        • St. Mary's/Duluth Clinic Health System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 120 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
incidence of drop-out or dose reduction
Time Frame: 2 years
incidence of drop-out or dose reduction due to toxicity within 6 months from the start of treatment.
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Time to progression
Time Frame: 2 years
2 years
Response rate
Time Frame: 2 years
2 years
Overall survival
Time Frame: 8 years
8 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NCIC Clinical Trials Group

Investigators

  • Study Chair: A. Keith Stewart, MD, Princess Margaret Hospital, Canada

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 12, 2000

Primary Completion (Actual)

May 3, 2002

Study Completion (Actual)

December 15, 2008

Study Registration Dates

First Submitted

December 6, 2000

First Submitted That Met QC Criteria

March 5, 2004

First Posted (Estimate)

March 8, 2004

Study Record Updates

Last Update Posted (Actual)

April 2, 2020

Last Update Submitted That Met QC Criteria

March 31, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MY9
  • CAN-NCIC-MY9 (Other Identifier: PDQ)
  • CELGENE-CAN-NCIC-MY9 (Other Identifier: Celgene)
  • CDR0000068337 (Other Identifier: PDQ)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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