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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
NCIC Clinical Trials Group
ClinicalTrials.gov Identifier:
NCT00006890
First received: December 6, 2000
Last updated: September 27, 2011
Last verified: September 2011
  Purpose

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 Intervention Phase
Multiple Myeloma and Plasma Cell Neoplasm
Drug: prednisone
Drug: thalidomide
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by NCIC Clinical Trials Group:

Primary Outcome Measures:
  • incidence of drop-out or dose reduction [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    incidence of drop-out or dose reduction due to toxicity within 6 months from the start of treatment.


Secondary Outcome Measures:
  • Response rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Time to progression [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: 8 years ] [ Designated as safety issue: No ]

Enrollment: 67
Study Start Date: July 2000
Study Completion Date: December 2008
Primary Completion Date: May 2002 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Prednisone plus Thalidomide
After Autologous Stem Cell Infusion
Drug: prednisone
Prednisone 50mg on alternate days
Drug: thalidomide
THALIDOMIDE 200 mg qhs

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.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00006890

  Show 64 Study Locations
Sponsors and Collaborators
NCIC Clinical Trials Group
Investigators
Study Chair: A. Keith Stewart, MD Princess Margaret Hospital, Canada
  More Information

Additional Information:
Publications:
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.

Responsible Party: NCIC Clinical Trials Group
ClinicalTrials.gov Identifier: NCT00006890     History of Changes
Other Study ID Numbers: MY9, CAN-NCIC-MY9, CELGENE-CAN-NCIC-MY9, CDR0000068337
Study First Received: December 6, 2000
Last Updated: September 27, 2011
Health Authority: United States: Federal Government

Keywords provided by NCIC Clinical Trials Group:
refractory multiple myeloma
stage I multiple myeloma
stage II multiple myeloma
stage III multiple myeloma

Additional relevant MeSH terms:
Neoplasms
Multiple Myeloma
Neoplasms, Plasma Cell
Plasmacytoma
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Prednisone
Thalidomide
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anti-Inflammatory Agents
Immunosuppressive Agents
Immunologic Factors
Leprostatic Agents
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on July 22, 2014