Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	16 and over	Pharmaceutical / Industry	CAN-NCIC-MY9 CELGENE-CAN-NCIC-MY9, NCT00006890, MY9

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.

Entry Criteria

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

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

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)

Expected Enrollment

A total of 40-80 patients (20-40 per arm) will be accrued for this study 
within 17-21 months.

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.

Stewart KA, Chen C, Howson-Jan K, et al.: Results of a multi-center randomized phase II trial of thalidomide and prednisone maintenance therapy for multiple myeloma following autologous stem cell transplant. [Abstract] Blood 104 (11 Pt 1): A-335, 2004.

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.

Trial Contact Information

Trial Lead Organizations

NCIC-Clinical Trials Group

A. Keith Stewart, MD, Protocol chair(Contact information may not be current)		Ph: 416-946-4566 Email: kstewart@uhnres.utoronto.ca

Registry Information
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
Trial Start Date		2000-07-12
Registered in ClinicalTrials.gov		NCT00006890
Date Submitted to PDQ		2000-10-24
Information Last Verified		2005-01-13

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