Combination Chemotherapy in Treating Patients With Multiple Myeloma

Last updated: March 31, 2020
Sponsor: NCIC Clinical Trials Group
Overall Status: Completed

Phase

3

Condition

Lymphoproliferative Disorders

Red Blood Cell Disorders

Bone Neoplasm

Treatment

N/A

Clinical Study ID

NCT00002678
MY7
CDR0000064328
CAN-NCIC-MY7
NCI-V95-0713
  • Ages 18-120
  • All Genders

Study Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which combination chemotherapy regimen is most effective in treating patients with multiple myeloma.

PURPOSE: Randomized phase III trial to compare the effectiveness of various combination chemotherapy regimens in treating patients with multiple myeloma.

Eligibility Criteria

Inclusion

DISEASE CHARACTERISTICS:

  • Histologically proven previously untreated stage I-III multiple myeloma

  • Patients with stage I disease must be symptomatic

  • Must meet at least 1 of the following conditions:

  • Plasma cells in osteolytic lesion or soft tissue tumor biopsy

  • At least 10% plasmacytosis in bone marrow aspirate and/or biopsy

  • Less than 10% plasma cells in bone marrow but at least 1 bony lesion

  • Detectable serum M-component of IgG, IgA, IgD, or IgE

  • If only light chain disease (urine M-protein) present, urinary excretion of light chain (Bence Jones) protein must be at least 1.0 g/24 hours

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • ECOG 0-4

Life expectancy:

  • Not specified

Hematopoietic:

  • Not specified

Hepatic:

  • Not specified

Renal:

  • Not specified

Other:

  • No other concurrent serious illness

  • Concurrent diabetes allowed, at the discretion of the treating physician, if changes in insulin requirements can be managed

  • No other prior or concurrent malignancy except curatively treated nonmelanomatous skin cancer or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No concurrent immunizations

  • No concurrent filgrastim (G-CSF) or other growth factors as prophylaxis

  • Concurrent epoetin alfa for anemia allowed

Chemotherapy:

  • No prior chemotherapy

Endocrine therapy:

  • Prior dexamethasone or prednisone with radiotherapy for spinal cord compression allowed if cumulative dexamethasone dose no greater than 120 mg and cumulative prednisone dose no greater than 792 mg

  • Prior or concurrent corticosteroids for hypercalcemia allowed

Radiotherapy:

  • See Endocrine therapy

  • Prior focal radiotherapy allowed

  • Concurrent focal radiotherapy during induction allowed

  • Concurrent radiotherapy for palliation (e.g., painful osteolytic lesions or spinal cord compression) allowed

Surgery:

  • At least 2 years since prior surgery for radiologic or endoscopic diagnosis of gastric or duodenal ulcer

Other:

  • At least 2 years since prior medication for radiologic or endoscopic diagnosis of gastric or duodenal ulcer

  • Prior or concurrent bisphosphonates for hypercalcemia allowed

Study Design

Total Participants: 595
Study Start date:
June 02, 1995
Estimated Completion Date:
December 21, 2009

Study Description

OBJECTIVES:

  • Compare the overall survival of patients with previously untreated stage I-III multiple myelome treated with melphalan combined with dexamethasone or prednisone as induction therapy.

  • Compare the overall survival of patients with stable or responding disease after induction treated with dexamethasone vs observation alone as maintenance therapy.

  • Compare the time to progression, response rate, and quality of life of patients treated with these regimens.

  • Compare the toxic effects of these regimens in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified by center, stage (I or II vs III), creatinine (less than 2.0 mg/dL vs 2.0 mg/dL or greater), and intention to use prophylactic bisphosphonate (yes vs no).

  • Induction: Patients are randomized to 1 of 4 treatment arms.

    • Arms I and II: Patients receive induction comprising oral prednisone followed by oral melphalan on days 1-4.

    • Arms III and IV: Patients receive induction comprising oral melphalan and oral dexamethasone (DM) on days 1-4 of all courses and DM on days 15-18 of courses 1-3.

Induction for arms I-IV continues every 4 weeks for 12 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease after induction proceed to maintenance therapy.

  • Maintenance:

    • Arms I and III: Patients undergo observation.

    • Arms II and IV: Patients receive oral DM on days 1-4. Maintenance therapy continues every 4 weeks for arms II and IV and every 3 months for arms I and III in the absence of disease progression or unacceptable toxicity. Patients on arms I-IV who develop disease progression proceed to reinduction.

  • Reinduction: Patients restart induction on the arm to which they were originally randomized. Reinduction continues every 4 weeks in the absence of stable response lasting 16 weeks, disease progression, or unacceptable toxicity. Patients who achieve a stable response lasting 16 weeks restart maintenance therapy. Patients who experience further disease progression during reinduction are taken off study.

Quality of life is assessed at baseline, on day 1 of courses 1-3 and then every 3 courses during induction, and then every 3 months during maintenance therapy.

Patients are followed every 6 months.

PROJECTED ACCRUAL: A maximum of 600 patients will be accrued for this study within 6 years.

Connect with a study center

  • Tom Baker Cancer Center - Calgary

    Calgary, Alberta T2N 4N2
    Canada

    Site Not Available

  • Cross Cancer Institute

    Edmonton, Alberta T6G 1Z2
    Canada

    Site Not Available

  • British Columbia Cancer Agency - Centre for the Southern Interior

    Kelowna, British Columbia V1Y 5L3
    Canada

    Site Not Available

  • British Columbia Cancer Agency

    Vancouver, British Columbia V5Z 4E6
    Canada

    Site Not Available

  • Providence Health Care - Vancouver

    Vancouver, British Columbia V6Z 1Y6
    Canada

    Site Not Available

  • British Columbia Cancer Agency - Vancouver Island Cancer Centre

    Victoria, British Columbia V8R 6V5
    Canada

    Site Not Available

  • Doctor Leon Richard Oncology Centre

    Moncton, New Brunswick E1C 8X3
    Canada

    Site Not Available

  • Moncton Hospital

    Moncton, New Brunswick E1C 6ZB
    Canada

    Site Not Available

  • Saint John Regional Hospital

    Saint John, New Brunswick E2L 4L2
    Canada

    Site Not Available

  • Newfoundland Cancer Treatment and Research Foundation

    St. Johns, Newfoundland and Labrador A1B 3V6
    Canada

    Site Not Available

  • Nova Scotia Cancer Centre

    Halifax, Nova Scotia B3H 2Y9
    Canada

    Site Not Available

  • William Osler Health Centre

    Brampton, Ontario L6W 2Z8
    Canada

    Site Not Available

  • Cancer Care Ontario-Hamilton Regional Cancer Centre

    Hamilton, Ontario L8V 5C2
    Canada

    Site Not Available

  • Kingston Regional Cancer Centre

    Kingston, Ontario K7L 5P9
    Canada

    Site Not Available

  • Cancer Care Ontario-London Regional Cancer Centre

    London, Ontario N6A 4L6
    Canada

    Site Not Available

  • Credit Valley Hospital

    Mississauga, Ontario L5M 2N1
    Canada

    Site Not Available

  • Trillium Health Centre

    Mississauga, Ontario L5B 1B8
    Canada

    Site Not Available

  • Southlake Regional Health Centre

    Newmarket, Ontario L3Y 2P9
    Canada

    Site Not Available

  • Lakeridge Health Oshawa

    Oshawa, Ontario L1G 2B9
    Canada

    Site Not Available

  • Algoma District Medical Group

    Sault Sainte Marie, Ontario P6B 1Y5
    Canada

    Site Not Available

  • Hotel Dieu Health Sciences Hospital - Niagara

    St. Catharines, Ontario L2R 5K3
    Canada

    Site Not Available

  • Northeastern Ontario Regional Cancer Centre, Sudbury

    Sudbury, Ontario P3E 5J1
    Canada

    Site Not Available

  • Princess Margaret Hospital

    Toronto, Ontario M5G 2M9
    Canada

    Site Not Available

  • St. Michael's Hospital - Toronto

    Toronto, Ontario M5B 1W8
    Canada

    Site Not Available

  • Toronto East General Hospital

    Toronto, Ontario M4C 3E7
    Canada

    Site Not Available

  • Toronto General Hospital

    Toronto, Ontario M5G 2C4
    Canada

    Site Not Available

  • Toronto Sunnybrook Regional Cancer Centre

    Toronto, Ontario M4N 3M5
    Canada

    Site Not Available

  • Humber River Regional Hospital

    Weston, Ontario M9N 1N8
    Canada

    Site Not Available

  • Cancer Care Ontario - Windsor Regional Cancer Centre

    Windsor, Ontario N8W 2X3
    Canada

    Site Not Available

  • Queen Elizabeth Hospital, PEI

    Charlottetown, Prince Edward Island C1A 8T5
    Canada

    Site Not Available

  • CHUS-Hopital Fleurimont

    Fleurimont, Quebec J1H 5N4
    Canada

    Site Not Available

  • Hopital Charles Lemoyne

    Greenfield Park, Quebec J4V 2H1
    Canada

    Site Not Available

  • McGill University

    Montreal, Quebec H2W 1S6
    Canada

    Site Not Available

  • Hopital de L'Enfant Jesus

    Quebec City, Quebec G1J 1Z4
    Canada

    Site Not Available

  • Hopital du Saint-Sacrement, Quebec

    Quebec City, Quebec G1S 4L8
    Canada

    Site Not Available

  • Allan Blair Cancer Centre

    Regina, Saskatchewan S4T 7T1
    Canada

    Site Not Available

  • St. Mary's/Duluth Clinic Health System

    Duluth, Minnesota 55805
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.