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A Randomized Phase II Dose Finding Study Of Thalidomide And Prednisone As Maintenance Therapy Following Autologous Stem Cell Transplant In Patients With Multiple Myeloma


Phase 2
16 Years
N/A
Not Enrolling
Both
Multiple Myeloma and Plasma Cell Neoplasm

Thank you

Trial Information

A Randomized Phase II Dose Finding Study Of Thalidomide And Prednisone As Maintenance Therapy Following Autologous Stem Cell Transplant In Patients With Multiple Myeloma


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

incidence of drop-out or dose reduction

Outcome Description:

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

Outcome Time Frame:

2 years

Safety Issue:

Yes

Principal Investigator

A. Keith Stewart, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Princess Margaret Hospital, Canada

Authority:

United States: Federal Government

Study ID:

MY9

NCT ID:

NCT00006890

Start Date:

July 2000

Completion Date:

December 2008

Related Keywords:

  • Multiple Myeloma and Plasma Cell Neoplasm
  • refractory multiple myeloma
  • stage I multiple myeloma
  • stage II multiple myeloma
  • stage III multiple myeloma
  • Neoplasms
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Plasmacytoma

Name

Location

St. Mary's/Duluth Clinic Health SystemDuluth, Minnesota  55805