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Multiple Myeloma and Plasma Cell NeoplasmPhase 2NCT00006890

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

A Phase 2 study testing prednisone and thalidomide in people with Multiple Myeloma and Plasma Cell Neoplasm, run by NCIC Clinical Trials Group at 64 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 16 to 120 years
What is being tested?
prednisone and thalidomide
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
67 participants
Where
64 sitesin 2 countries
Study dates
12 Jul 2000to 15 Dec 2008
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 to 120 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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

Trial locations and contacts

64 sites in 2 countries.

64 sites in 2 countries

Canada63 sites

  • Royal Victoria Hospital, Barrie

    Barrie, Ontario, L4M 6M2

  • William Osler Health Centre

    Brampton, Ontario, L6W 2Z8

  • Burnaby Hospital Regional Cancer Centre

    Burnaby, British Columbia, V5H 4C2

  • Tom Baker Cancer Center - Calgary

    Calgary, Alberta, T2N 4N2

  • Queen Elizabeth Hospital, PEI

    Charlottetown, Prince Edward Island, C1A 8T5

  • CHUS-Hopital Fleurimont

    Fleurimont, Quebec, J1H 5N4

  • Northeastern Ontario Regional Cancer Centre, Sudbury

    Greater Sudbury, Ontario, P3E 5J1

  • Hopital Charles Lemoyne

    Greenfield Park, Quebec, J4V 2H1

  • Nova Scotia Cancer Centre

    Halifax, Nova Scotia, B3H 1V7

  • Hamilton and Disrict Urology Association

    Hamilton, Ontario, L8N 1T8

  • Centre Hospitalier Regional de Lanaudiere

    Joliette, Quebec, J6E 6J2

  • Lethbridge Cancer Clinic

    Lethbridge, Alberta, T1J 1W5

  • London Health Sciences Centre

    London, Ontario, N6A 4G5

  • Cancer Care Ontario-London Regional Cancer Centre

    London, Ontario, N6A 4L6

  • Markham Stouffville Hospital

    Markham, Ontario, L3P 7T3

  • Trillium Health Centre

    Mississauga, Ontario, L5B 1B8

  • Credit Valley Hospital

    Mississauga, Ontario, L5M 2N1

  • Moncton Hospital

    Moncton, New Brunswick, E1C 6ZB

  • Doctor Leon Richard Oncology Centre

    Moncton, New Brunswick, E1C 8X3

  • Maisonneuve-Rosemont Hospital

    Montreal, Quebec, H1T 2M4

  • McGill University

    Montreal, Quebec, H2W 1S6

  • Centre Hospitalier de l'Universite' de Montreal

    Montreal, Quebec, H2W 1T8

  • Hotel Dieu de Montreal

    Montreal, Quebec, H2W 1T8

  • Hopital Sainte Justine

    Montreal, Quebec, H3T 1C5

  • Hopital Du Sacre-Coeur de Montreal

    Montreal, Quebec, H4J 1C5

  • Nanaimo Cancer Clinic

    Nanaimo, British Columbia, V9S 2B7

  • York County Hospital

    Newmarket, Ontario, L3Y 2P9

  • Lions Gate Hospital

    North Vancouver, V7L 2P9

  • North York General Hospital, Ontario

    North York, Ontario, M2E 1K1

  • Male Health Centre/CMX Research Inc.

    Oakville, Ontario, L6H 3PI

  • Lakeridge Health Oshawa

    Oshawa, Ontario, L1G 2B9

  • Ottawa Regional Cancer Centre - General Campus

    Ottawa, Ontario, K1H 1C4

  • Ottawa Regional Cancer Center - General Division

    Ottawa, Ontario, K1H 8L6

  • Penticton Regional Hospital

    Penticton, British Columbia, V2A 3G6

  • Peterborough Oncology Clinic

    Peterborough, Ontario, K9H 7B6

  • Kells Medical Research Group Inc.

    Pointe-Claire, Quebec, H9R 4S3

  • CHU de Quebec - L'Hotel-Dieu de Quebec

    Québec, Quebec, G1R 2J6

  • Hopital du Saint-Sacrament, Quebec

    Québec, Quebec, G1S 4L8

  • Allan Blair Cancer Centre

    Regina, Saskatchewan, S4T 7T1

  • Centre Hospitalier Regional de Rimouski

    Rimouski, Quebec, G5L 5T1

  • Saint John Regional Hospital

    Saint John, New Brunswick, E2L 4L2

  • Saskatoon Cancer Centre

    Saskatoon, Saskatchewan, S7N 4H4

  • Scarborough Hospital - General Site

    Scarborough Village, Ontario, M1P 2V5

  • Hotel Dieu Health Sciences Hospital - Niagara

    St. Catharines, Ontario, L2R 5K3

  • Newfoundland Cancer Treatment and Research Foundation

    St. John's, Newfoundland and Labrador, A1B 3V6

  • L'Hopital Laval

    Ste-Foy, Quebec, G1V 4G5

  • British Columbia Cancer Agency - Fraser Valley Cancer Centre

    Surrey, British Columbia, V3V 1Z2

  • Cape Breton Cancer Centre

    Sydney, Nova Scotia, B1P 1PS

  • Northwestern Ontario Regional Cancer Centre, Thunder Bay

    Thunder Bay, Ontario, P7A 7T1

  • Toronto East General Hospital

    Toronto, Ontario, M4C 3E7

  • Toronto Sunnybrook Regional Cancer Centre

    Toronto, Ontario, M4N 3M5

  • St. Michael's Hospital - Toronto

    Toronto, Ontario, M5B 1W8

  • Mount Sinai Hospital - Toronto

    Toronto, Ontario, M5G 1X5

  • Toronto General Hospital

    Toronto, Ontario, M5G 2C4

  • Princess Margaret Hospital

    Toronto, Ontario, M5G 2M9

  • Women's College Campus, Sunnybrook and Women's College Health Science Center

    Toronto, Ontario, M5S 1B6

  • Saint Joseph's Health Centre - Toronto

    Toronto, Ontario, M6R 1B5

  • Prostate Centre at Vancouver General Hospital

    Vancouver, British Columbia, V5Z 3J5

  • British Columbia Cancer Agency

    Vancouver, British Columbia, V5Z 4E6

  • St. Paul's Hospital - Vancouver

    Vancouver, British Columbia, V6Z 1Y6

  • G. Steinhoff Clinical Research

    Victoria, British Columbia, V8V 3N1

  • Humber River Regional Hospital

    Weston, Ontario, M9N 1N8

  • Cancer Care Ontario - Windsor Regional Cancer Centre

    Windsor, Ontario, N8W 2X3

Other trials in Canada

United States1 site

  • St. Mary's/Duluth Clinic Health System

    Duluth, Minnesota, 55805

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
prednisone, thalidomide
Keywords
refractory multiple myeloma, stage I multiple myeloma, stage II multiple myeloma, stage III multiple myeloma
Medical subject headings
Multiple Myeloma, Neoplasms, Plasma Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00006890
Study groupRoleWhat they receive
Prednisone plus ThalidomideExperimentalAfter Autologous Stem Cell Infusion
Receives: Drug: prednisone; Drug: thalidomide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. incidence of drop-out or dose reduction

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

    Measured: 2 years

Secondary outcomes (3)

  1. Response rate

    Measured: 2 years

  2. Time to progression

    Measured: 2 years

  3. Overall survival

    Measured: 8 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Mar 2004 (estimated)
  2. Study start12 Jul 2000
  3. Primary completion3 May 2002
  4. Study completion15 Dec 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
67 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00006890
Sponsor's protocol ID
MY9
Other IDs
CAN-NCIC-MY9, CELGENE-CAN-NCIC-MY9, CDR0000068337
Status last verified
Mar 2020
First submitted
6 Dec 2000
Last updated
2 Apr 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Stewart AK, Chen CI, Howson-Jan K, White D, Roy J, Kovacs MJ, Shustik C, Sadura A, Shepherd L, Ding K, Meyer RM, Belch AR. Results of a multicenter randomized phase II trial of thalidomide and prednisone maintenance therapy for multiple myeloma after autologous stem cell transplant. Clin Cancer Res. 2004 Dec 15;10(24):8170-6. doi: 10.1158/1078-0432.CCR-04-1106.

    PubMed 15623591

  • Stewart KA, Chen C, Howson-Jan K, et al.: A randomized phase II dose-finding trial of thalidomide and prednisone as maintenance therapy for myeloma following autologous stem cell transplant. [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-1073, 2002.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing prednisone and thalidomide in people with Multiple Myeloma and Plasma Cell Neoplasm, run by NCIC Clinical Trials Group at 64 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 64 sites in Canada, United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

incidence of drop-out or dose reduction (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00006890, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2020.

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