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A Randomized Phase III Study Of Thalidomide And Prednisone As Maintenance Therapy Following Autologous Stem Cell Transplant in Patients With Multiple Myeloma

Phase 3
16 Years
Open (Enrolling)
Multiple Myeloma and Plasma Cell Neoplasm

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Trial Information

A Randomized Phase III Study Of Thalidomide And Prednisone As Maintenance Therapy Following Autologous Stem Cell Transplant in Patients With Multiple Myeloma


- Compare overall survival of patients with multiple myeloma treated with thalidomide and
prednisone as maintenance therapy vs observation alone after autologous stem cell

- 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.

Inclusion Criteria


- 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



- 16 and over

Performance status

- ECOG 0-2

Life expectancy

- At least 6 months


- No prior hereditary hypercoaguable disorder

- Granulocyte count at least 1,000/mm^3

- Platelet count at least 75,000/mm^3


- 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


- Creatinine no greater than 3 times ULN


- No prior spontaneous deep vein thrombosis within the past 5 years

- Catheter-associated thrombus allowed

- No uncontrolled hypertension


- No prior pulmonary embolism within the past 5 years


- 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


Biologic therapy

- See Disease Characteristics

- No prior double autologous or allogeneic hematopoietic stem cell transplantation

- No prior thalidomide


- See Disease Characteristics

Endocrine therapy

- Not specified


- Not specified


- Not specified


- No other concurrent anti-cancer therapy

- No other concurrent investigational therapy

Type of Study:


Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall survival

Outcome Time Frame:

11 years

Safety Issue:


Principal Investigator

A. Keith Stewart, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic


Canada: Health Canada

Study ID:




Start Date:

September 2002

Completion Date:

December 2013

Related Keywords:

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