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

Sponsor
NCIC Clinical Trials Group (Other)
Overall Status
Completed
CT.gov ID
NCT00006890
Collaborator
(none)
67
64
1
101.1
1
0

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

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 Design

Study Type:
Interventional
Actual Enrollment :
67 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Randomized Phase II Dose Finding Study Of Thalidomide And Prednisone As Maintenance Therapy Following Autologous Stem Cell Transplant In Patients With Multiple Myeloma
Actual Study Start Date :
Jul 12, 2000
Actual Primary Completion Date :
May 3, 2002
Actual Study Completion Date :
Dec 15, 2008

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. incidence of drop-out or dose reduction [2 years]

    incidence of drop-out or dose reduction due to toxicity within 6 months from the start of treatment.

Secondary Outcome Measures

  1. Response rate [2 years]

  2. Time to progression [2 years]

  3. Overall survival [8 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:
16 Years to 120 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No

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

Contacts and Locations

Locations

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

Sponsors and Collaborators

  • NCIC Clinical Trials Group

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
NCIC Clinical Trials Group
ClinicalTrials.gov Identifier:
NCT00006890
Other Study ID Numbers:
  • MY9
  • CAN-NCIC-MY9
  • CELGENE-CAN-NCIC-MY9
  • CDR0000068337
First Posted:
Mar 8, 2004
Last Update Posted:
Apr 2, 2020
Last Verified:
Mar 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by NCIC Clinical Trials Group
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 2, 2020