search
Back to results

Thalidomide and Prednisone After Autologous Stem Cell Transplantation Multiple Myeloma

Primary Purpose

Multiple Myeloma and Plasma Cell Neoplasm

Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
prednisone
thalidomide
Sponsored by
NCIC Clinical Trials Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Myeloma and Plasma Cell Neoplasm focused on measuring stage I multiple myeloma, stage II multiple myeloma, stage III multiple myeloma

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Tom Baker Cancer Centre
  • Cross Cancer Institute
  • BCCA - Vancouver Cancer Centre
  • CancerCare Manitoba
  • The Moncton Hospital
  • Atlantic Health Sciences Corporation
  • Dr. H. Bliss Murphy Cancer Centre
  • QEII Health Sciences Center
  • Juravinski Cancer Centre at Hamilton Health Sciences
  • Cancer Centre of Southeastern Ontario at Kingston
  • London Regional Cancer Program
  • Odette Cancer Centre
  • Univ. Health Network-Princess Margaret Hospital
  • Hopital Maisonneuve-Rosemont
  • McGill University - Dept. Oncology
  • CHA-Hopital Du St-Sacrement
  • Centre hospitalier universitaire de Sherbrooke
  • Saskatoon Cancer Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Arm I

Arm II

Arm Description

Patients receive oral thalidomide daily and oral prednisone every other day for 4 years in the absence of disease progression or unacceptable toxicity.

Patients undergo observation.

Outcomes

Primary Outcome Measures

Overall Survival
Number of patients died from any cause during the study.

Secondary Outcome Measures

Disease Progression-free Survival
Number of patients with disease progression or death

Full Information

First Posted
November 12, 2002
Last Updated
September 7, 2023
Sponsor
NCIC Clinical Trials Group
Collaborators
National Cancer Institute (NCI), Eastern Cooperative Oncology Group
search

1. Study Identification

Unique Protocol Identification Number
NCT00049673
Brief Title
Thalidomide and Prednisone After Autologous Stem Cell Transplantation Multiple Myeloma
Official Title
A Randomized Phase III Study Of Thalidomide And Prednisone As Maintenance Therapy Following Autologous Stem Cell Transplant in Patients With Multiple Myeloma
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
October 15, 2002 (Actual)
Primary Completion Date
October 19, 2011 (Actual)
Study Completion Date
September 19, 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NCIC Clinical Trials Group
Collaborators
National Cancer Institute (NCI), Eastern Cooperative Oncology Group

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma and Plasma Cell Neoplasm
Keywords
stage I multiple myeloma, stage II multiple myeloma, stage III multiple myeloma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
332 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm I
Arm Type
Experimental
Arm Description
Patients receive oral thalidomide daily and oral prednisone every other day for 4 years in the absence of disease progression or unacceptable toxicity.
Arm Title
Arm II
Arm Type
No Intervention
Arm Description
Patients undergo observation.
Intervention Type
Drug
Intervention Name(s)
prednisone
Intervention Description
Given orally
Intervention Type
Drug
Intervention Name(s)
thalidomide
Intervention Description
Given orally
Primary Outcome Measure Information:
Title
Overall Survival
Description
Number of patients died from any cause during the study.
Time Frame
9 years
Secondary Outcome Measure Information:
Title
Disease Progression-free Survival
Description
Number of patients with disease progression or death
Time Frame
9 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
A. Keith Stewart, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Martha Q. Lacy, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Study Chair
Facility Information:
Facility Name
Tom Baker Cancer Centre
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N2
Country
Canada
Facility Name
Cross Cancer Institute
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
Facility Name
BCCA - Vancouver Cancer Centre
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 4E6
Country
Canada
Facility Name
CancerCare Manitoba
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3E 0V9
Country
Canada
Facility Name
The Moncton Hospital
City
Moncton
State/Province
New Brunswick
ZIP/Postal Code
E1C 6Z8
Country
Canada
Facility Name
Atlantic Health Sciences Corporation
City
Saint John
State/Province
New Brunswick
ZIP/Postal Code
E2L 4L2
Country
Canada
Facility Name
Dr. H. Bliss Murphy Cancer Centre
City
St. John's
State/Province
Newfoundland and Labrador
ZIP/Postal Code
AIB 3V6
Country
Canada
Facility Name
QEII Health Sciences Center
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 1V7
Country
Canada
Facility Name
Juravinski Cancer Centre at Hamilton Health Sciences
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8V 5C2
Country
Canada
Facility Name
Cancer Centre of Southeastern Ontario at Kingston
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 5P9
Country
Canada
Facility Name
London Regional Cancer Program
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4L6
Country
Canada
Facility Name
Odette Cancer Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
Univ. Health Network-Princess Margaret Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
Hopital Maisonneuve-Rosemont
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 2M4
Country
Canada
Facility Name
McGill University - Dept. Oncology
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2W 1S6
Country
Canada
Facility Name
CHA-Hopital Du St-Sacrement
City
Quebec City
State/Province
Quebec
ZIP/Postal Code
G1S 4L8
Country
Canada
Facility Name
Centre hospitalier universitaire de Sherbrooke
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada
Facility Name
Saskatoon Cancer Centre
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7N 4H4
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23297129
Citation
Stewart AK, Trudel S, Bahlis NJ, White D, Sabry W, Belch A, Reiman T, Roy J, Shustik C, Kovacs MJ, Rubinger M, Cantin G, Song K, Tompkins KA, Marcellus DC, Lacy MQ, Sussman J, Reece D, Brundage M, Harnett EL, Shepherd L, Chapman JA, Meyer RM. A randomized phase 3 trial of thalidomide and prednisone as maintenance therapy after ASCT in patients with MM with a quality-of-life assessment: the National Cancer Institute of Canada Clinicals Trials Group Myeloma 10 Trial. Blood. 2013 Feb 28;121(9):1517-23. doi: 10.1182/blood-2012-09-451872. Epub 2013 Jan 7.
Results Reference
result
PubMed Identifier
25302852
Citation
Kovacs MJ, Davies GA, Chapman JA, Bahlis N, Voralia M, Roy J, Kouroukis CT, Chen C, Belch A, Reece D, Zhu L, Meyer RM, Shepherd L, Stewart KA. Thalidomide-prednisone maintenance following autologous stem cell transplant for multiple myeloma: effect on thrombin generation and procoagulant markers in NCIC CTG MY.10. Br J Haematol. 2015 Feb;168(4):511-7. doi: 10.1111/bjh.13176. Epub 2014 Oct 10.
Results Reference
derived

Learn more about this trial

Thalidomide and Prednisone After Autologous Stem Cell Transplantation Multiple Myeloma

We'll reach out to this number within 24 hrs