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Multiple Myeloma and Plasma Cell NeoplasmPhase 3NCT00049673

Thalidomide and Prednisone After Autologous Stem Cell Transplantation Multiple Myeloma

A Phase 3 study testing prednisone and thalidomide in people with Multiple Myeloma and Plasma Cell Neoplasm, run by NCIC Clinical Trials Group at 18 sites in Canada.

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. 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. Read more about this study

Who is it for?
Ages 16 years and older
What is being tested?
prednisone and thalidomide
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
332 participants
Where
18 sitesCanada
Study dates
15 Oct 2002to 19 Sep 2013
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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

Trial locations and contacts

18 sites in 1 country.

18 sites in 1 country

Canada18 sites

  • Tom Baker Cancer Centre

    Calgary, Alberta, T2N 4N2

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2

  • QEII Health Sciences Center

    Halifax, Nova Scotia, B3H 1V7

  • Juravinski Cancer Centre at Hamilton Health Sciences

    Hamilton, Ontario, L8V 5C2

  • Cancer Centre of Southeastern Ontario at Kingston

    Kingston, Ontario, K7L 5P9

  • London Regional Cancer Program

    London, Ontario, N6A 4L6

  • The Moncton Hospital

    Moncton, New Brunswick, E1C 6Z8

  • Hopital Maisonneuve-Rosemont

    Montreal, Quebec, H1T 2M4

  • McGill University - Dept. Oncology

    Montreal, Quebec, H2W 1S6

  • CHA-Hopital Du St-Sacrement

    Québec, Quebec, G1S 4L8

  • Atlantic Health Sciences Corporation

    Saint John, New Brunswick, E2L 4L2

  • Saskatoon Cancer Centre

    Saskatoon, Saskatchewan, S7N 4H4

  • Centre hospitalier universitaire de Sherbrooke

    Sherbrooke, Quebec, J1H 5N4

  • Dr. H. Bliss Murphy Cancer Centre

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

  • Odette Cancer Centre

    Toronto, Ontario, M4N 3M5

  • Univ. Health Network-Princess Margaret Hospital

    Toronto, Ontario, M5G 2M9

  • BCCA - Vancouver Cancer Centre

    Vancouver, British Columbia, V5Z 4E6

  • CancerCare Manitoba

    Winnipeg, Manitoba, R3E 0V9

Other trials in Canada

About this study

Official title: A Randomized Phase III 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. 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.

Read the 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.

Being tested
prednisone, thalidomide
Keywords
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 NCT00049673
Study groupRoleWhat they receive
Arm IExperimentalPatients receive oral thalidomide daily and oral prednisone every other day for 4 years in the absence of disease progression or unacceptable toxicity.
Receives: Drug: prednisone; Drug: thalidomide
Arm IINo interventionPatients undergo observation.

What is being measured

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

  1. Overall Survival

    Number of patients died from any cause during the study.

    Measured: 9 years

Secondary outcomes (1)

  1. Disease Progression-free Survival

    Number of patients with disease progression or death

    Measured: 9 years

Timeline

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

  1. First posted27 Jan 2003 (estimated)
  2. Study start15 Oct 2002
  3. Primary completion19 Oct 2011
  4. Study completion19 Sep 2013

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
332 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00049673
Sponsor's protocol ID
MY10
Other IDs
CAN-NCIC-JMY10, ECOG-NCIC-JMY10, CELGENE-CAN-NCIC-MY10, CDR0000258158
Status last verified
Sep 2023
First submitted
12 Nov 2002
Last updated
13 Sep 2023
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 23297129

  • 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.

    PubMed 25302852

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing prednisone and thalidomide in people with Multiple Myeloma and Plasma Cell Neoplasm, run by NCIC Clinical Trials Group at 18 sites in Canada.

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 13 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in Canada. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Oct 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Overall Survival (time frame: 9 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 NCT00049673, 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 13 Sep 2023.

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