Thalidomide and Prednisone After Autologous Stem Cell Transplantation in Treating Patients With Multiple Myeloma

This study has been completed.
Sponsor:
Collaborators:
Eastern Cooperative Oncology Group
Information provided by (Responsible Party):
NCIC Clinical Trials Group ( Canadian Cancer Society Research Institute (CCSRI) )
ClinicalTrials.gov Identifier:
NCT00049673
First received: November 12, 2002
Last updated: September 19, 2013
Last verified: September 2013
  Purpose

RATIONALE: Thalidomide may stop the growth of multiple myeloma by stopping blood flow to the tumor. It is not yet known whether combining thalidomide with prednisone and giving them after autologous stem cell transplantation may be effective in treating multiple myeloma.

PURPOSE: This randomized phase III trial is studying thalidomide and prednisone to see how well they work compared to observation in treating patients who have undergone stem cell transplantation for multiple myeloma.


Condition Intervention Phase
Multiple Myeloma and Plasma Cell Neoplasm
Drug: prednisone
Drug: thalidomide
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Phase III Study Of Thalidomide And Prednisone As Maintenance Therapy Following Autologous Stem Cell Transplant in Patients With Multiple Myeloma

Resource links provided by NLM:


Further study details as provided by NCIC Clinical Trials Group:

Primary Outcome Measures:
  • Overall survival [ Time Frame: 11 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to progression after reaching primary endpoint [ Time Frame: 11 years ] [ Designated as safety issue: No ]
  • Toxicity assessed by NCI CTC v2.0 [ Time Frame: 11 years ] [ Designated as safety issue: Yes ]
  • Quality of life assessed by EORTC QLQ C30 questionnaire [ Time Frame: 11 years ] [ Designated as safety issue: No ]
  • Incidence of venous thrombosis determined by objective imaging [ Time Frame: 11 years ] [ Designated as safety issue: No ]

Enrollment: 332
Study Start Date: September 2002
Study Completion Date: September 2013
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I
Patients receive oral thalidomide daily and oral prednisone every other day for 4 years in the absence of disease progression or unacceptable toxicity.
Drug: prednisone
Given orally
Drug: thalidomide
Given orally
No Intervention: Arm II
Patients undergo observation.

Detailed Description:

OBJECTIVES:

  • Compare overall survival of patients with multiple myeloma treated with thalidomide and prednisone as maintenance therapy vs observation alone after autologous stem cell transplantation.
  • Compare progression-free survival of patients treated with these regimens.
  • Compare quality of life of patients treated with these regimens.
  • Compare toxic effects of these regimens in these patients.
  • Compare the objective venous thromboembolism rate in symptomatic patients treated with these regimens.

OUTLINE: This is a randomized, non-blinded, multicenter study. Patients are stratified according to treatment center, age (under 60 vs 60 and over), and response to prior transplantation (complete vs incomplete). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive oral thalidomide daily and oral prednisone every other day for 4 years in the absence of disease progression or unacceptable toxicity.
  • Arm II: Patients undergo observation.

For both arms, patients are assessed (including for quality of life) regularly throughout the treatment/observation period: at baseline, every 2 months for 6 months, every 3 months for up to 4 years, and then annually thereafter.

After the treatment/observation period, patients are followed annually..

PROJECTED ACCRUAL: A total of 324 patients will be accrued for this study within 3.5 years.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed multiple myeloma as evidenced by one of the following:

    • 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 less than 10% plasma cells with at least 1 bony lesion and meets the M-protein criteria as below
  • Detectable serum M-component of IgG, IgA, IgD, or IgE at initial diagnosis OR
  • Urinary excretion of light chain (Bence Jones) protein at least 1.0 gm/24 hrs if only light chain disease (urine M-protein) was present at initial diagnosis
  • Previously treated with autologous stem cell transplantation after high-dose melphalan (200 mg/m^2) within the past 60-100 days

    • Received transplantation within 1 year of the beginning of initial chemotherapy for multiple myeloma
    • No evidence of disease progression

PATIENT CHARACTERISTICS:

Age

  • 16 and over

Performance status

  • ECOG 0-2

Life expectancy

  • At least 6 months

Hematopoietic

  • No prior hereditary hypercoaguable disorder
  • Granulocyte count at least 1,000/mm^3
  • Platelet count at least 75,000/mm^3

Hepatic

  • Bilirubin no greater than 2 times upper limit of normal (ULN)
  • AST and/or ALT no greater than 2 times ULN
  • Alkaline phosphatase no greater than 2 times ULN

Renal

  • Creatinine no greater than 3 times ULN

Cardiovascular

  • No prior spontaneous deep vein thrombosis within the past 5 years

    • Catheter-associated thrombus allowed
  • No uncontrolled hypertension

Pulmonary

  • No prior pulmonary embolism within the past 5 years

Other

  • No other prior or concurrent malignancy except adequately treated squamous cell or basal cell skin cancer or carcinoma in situ of the cervix or any cancer treated more than 5 years prior to study entry and presumed cured
  • No prior gastric ulceration or bleeding within the past 5 years
  • No prior documented lupus anti-coagulant or anti-phospholipid antibody
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile female patients must use 2 effective methods of contraception for 1 month prior, during, and 1 month after study participation
  • Male patients must use effective barrier contraception during and for 1 month after study participation
  • No avascular necrosis of the hips or shoulders
  • No grade 2 or greater peripheral neuropathy causing symptomatic dysfunction (vincristine-induced sensory symptoms allowed)
  • No diabetes with end-organ damage defined as:

    • Documented diabetic neuropathy
    • Retinal vascular proliferation requiring treatment
    • Cardiovascular disease requiring active therapy
  • Willing to complete quality of life questionnaires
  • Employment does not prohibit the use of sedatives
  • No other major medical illness or condition that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • See Disease Characteristics
  • No prior double autologous or allogeneic hematopoietic stem cell transplantation
  • No prior thalidomide

Chemotherapy

  • See Disease Characteristics

Endocrine therapy

  • Not specified

Radiotherapy

  • Not specified

Surgery

  • Not specified

Other

  • No other concurrent anti-cancer therapy
  • No other concurrent investigational therapy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00049673

Locations
Canada, Alberta
Tom Baker Cancer Centre
Calgary, Alberta, Canada, T2N 4N2
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Canada, British Columbia
BCCA - Vancouver Cancer Centre
Vancouver, British Columbia, Canada, V5Z 4E6
Canada, Manitoba
CancerCare Manitoba
Winnipeg, Manitoba, Canada, R3E 0V9
Canada, New Brunswick
The Moncton Hospital
Moncton, New Brunswick, Canada, E1C 6Z8
Atlantic Health Sciences Corporation
Saint John, New Brunswick, Canada, E2L 4L2
Canada, Newfoundland and Labrador
Dr. H. Bliss Murphy Cancer Centre
St. John's, Newfoundland and Labrador, Canada, AIB 3V6
Canada, Nova Scotia
QEII Health Sciences Center
Halifax, Nova Scotia, Canada, B3H 1V7
Canada, Ontario
Juravinski Cancer Centre at Hamilton Health Sciences
Hamilton, Ontario, Canada, L8V 5C2
Cancer Centre of Southeastern Ontario at Kingston
Kingston, Ontario, Canada, K7L 5P9
London Regional Cancer Program
London, Ontario, Canada, N6A 4L6
Odette Cancer Centre
Toronto, Ontario, Canada, M4N 3M5
Univ. Health Network-Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
McGill University - Dept. Oncology
Montreal, Quebec, Canada, H2W 1S6
Hopital Maisonneuve-Rosemont
Montreal, Quebec, Canada, H1T 2M4
CHA-Hopital Du St-Sacrement
Quebec City, Quebec, Canada, G1S 4L8
Centre hospitalier universitaire de Sherbrooke
Sherbrooke, Quebec, Canada, J1H 5N4
Canada, Saskatchewan
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, Canada, S7N 4H4
Sponsors and Collaborators
Canadian Cancer Society Research Institute (CCSRI)
Eastern Cooperative Oncology Group
Investigators
Study Chair: A. Keith Stewart, MD Mayo Clinic
Study Chair: Martha Q. Lacy, MD Mayo Clinic
  More Information

Additional Information:
No publications provided by NCIC Clinical Trials Group

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: NCIC Clinical Trials Group ( Canadian Cancer Society Research Institute (CCSRI) )
ClinicalTrials.gov Identifier: NCT00049673     History of Changes
Other Study ID Numbers: MY10, CAN-NCIC-MY10, CAN-NCIC-JMY10, ECOG-NCIC-JMY10, CELGENE-CAN-NCIC-MY10, CDR0000258158
Study First Received: November 12, 2002
Last Updated: September 19, 2013
Health Authority: Canada: Health Canada

Keywords provided by NCIC Clinical Trials Group:
stage I multiple myeloma
stage II multiple myeloma
stage III multiple myeloma

Additional relevant MeSH terms:
Neoplasms
Multiple Myeloma
Neoplasms, Plasma Cell
Plasmacytoma
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Prednisone
Thalidomide
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Leprostatic Agents
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on August 19, 2014