Dexamethasone With or Without Thalidomide in Treating Patients With Newly Diagnosed Multiple Myeloma

Not Recruiting

Trial ID: NCT00033332


RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Thalidomide may stop the growth of cancer by stopping blood flow to the tumor. Combining dexamethasone and thalidomide may kill more cancer cells. It is not yet known whether dexamethasone is more effective with or without thalidomide in treating multiple myeloma. PURPOSE: Randomized phase III trial to determine the effectiveness of dexamethasone with or without thalidomide in treating patients who have multiple myeloma.

Official Title

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

Stanford Investigator(s)

Anand Veeravagu
Anand Veeravagu

Associate Professor of Neurosurgery and, by courtesy, of Orthopaedic Surgery



   - 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

   - 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)


drug: dexamethasone

drug: pamidronate disodium

drug: thalidomide

drug: zoledronic acid

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305