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A Randomized Phase III Trial Of Thalidomide (NSC # 66847) Plus Dexamethasone Versus Dexamethasone In Newly Diagnosed Multiple Myeloma

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

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Trial Information

A Randomized Phase III Trial Of Thalidomide (NSC # 66847) Plus Dexamethasone Versus Dexamethasone In Newly Diagnosed Multiple Myeloma


- Compare the response rate of patients with newly diagnosed multiple myeloma treated
with dexamethasone with or without thalidomide.

- Compare the toxicity of these regimens in these patients.

- Assess the effect of thalidomide on bone marrow microvessel density and angiogenesis
grade and on the expression of vascular endothelial growth factor and basic fibroblast
growth factor in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2
treatment arms.

- Arm I: Patients receive oral thalidomide once daily on days 1-28 and oral dexamethasone
once daily on days 1-4, 9-12, and 17-20. Patients also receive either pamidronate IV
over 2-4 hours or zoledronate IV over 15 minutes on day 1 for bone strengthening.

- Arm II: Patients receive dexamethasone and pamidronate or zoledronate as in arm I.

Treatment in both arms repeats every 28 days for 4 courses in the absence of disease
progression or unacceptable toxicity. Patients may receive additional courses after the
fourth course at the physician's discretion.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then
annually for 2 years.

PROJECTED ACCRUAL: A total of 194 patients (97 per treatment arm) will be accrued for this

Inclusion Criteria


- Newly diagnosed symptomatic multiple myeloma confirmed by the following:

- Bone marrow plasmacytosis with at least 10% plasma cells or sheets of plasma
cells or biopsy-proven plasmacytosis

- Monoclonal protein (M protein) at least 1.0 g/dL on serum protein
electrophoresis or at least 200 mg of monoclonal light chain on a 24-hour urine
protein electrophoresis

- No smoldering myeloma or monoclonal gammopathy of undetermined significance



- 18 and over

Performance status:

- ECOG 0-2

Life expectancy:

- Not specified


- Absolute neutrophil count greater than 1,000/mm^3

- Platelet count greater than 50,000/mm^3

- Hemoglobin greater than 7 g/dL


- Bilirubin no greater than 1.5 mg/dL

- ALT and AST no greater than 2.5 times upper limit of normal


- Creatinine less than 3 mg/dL


- No prior or concurrent deep venous thrombosis


- Prior malignancy allowed provided the following criteria are met:

- Received prior treatment with curative intent

- Free of disease for the time period appropriate for cure of the specific cancer

- No grade 2 or greater peripheral neuropathy due to other medical conditions

- No active infection

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use 1 highly effective method and 1 additional method of
contraception for 1 month before, during, and for 4 weeks after study for women and
effective barrier contraception for men during and for 4 weeks after study


Biologic therapy:

- No prior biologic therapy for multiple myeloma

- No other concurrent biologic therapy for multiple myeloma


- No prior chemotherapy for multiple myeloma

- No other concurrent chemotherapy for multiple myeloma

Endocrine therapy:

- More than 6 months since prior systemic dexamethasone or glucocorticoids

- No concurrent corticosteroids


- At least 4 weeks since prior palliative, localized radiotherapy

- Concurrent palliative, localized radiotherapy allowed at the physician's discretion


- Not specified


- No prior systemic therapy for multiple myeloma, except bisphosphonates

- No concurrent anticoagulant therapy for deep vein thrombosis

- No concurrent barbiturates or alcohol (thalidomide arm)

Type of Study:


Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

S. V. Rajkumar, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic


United States: Federal Government

Study ID:




Start Date:

April 2002

Completion Date:

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



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