Clinical Trial: Thalidomide, Doxorubicin, and Dexamethasone in Treating Patients With Untreated Stage II or Stage III Multiple Myeloma

This study has been completed.

Sponsors and Collaborators: National Cancer Institute (NCI)
Memorial Sloan-Kettering Cancer Center
Information provided by: National Cancer Institute (NCI)

Purpose

RATIONALE: Thalidomide may stop the growth of multiple myeloma by stopping blood flow to the cancer cells. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining thalidomide with chemotherapy may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of thalidomide, doxorubicin, and dexamethasone in treating patients who have untreated stage II or stage III multiple myeloma.

Condition Treatment or Intervention Phase
stage II multiple myeloma
stage III multiple myeloma
 Drug: dexamethasone
 Drug: doxorubicin
 Drug: thalidomide
Phase II

MedlinePlus related topics:  Multiple Myeloma

Study Type: Interventional
Study Design: Treatment

Official Title: Phase II Study of Thalidomide, Doxorubicin, and Dexamethasone in Patients With Previously Untreated Stage II or III Multiple Myeloma

Further Study Details: 

Study start: August 2000

OBJECTIVES: I. Determine the response rate of patients with previously untreated stage II or III multiple myeloma treated with thalidomide, doxorubicin, and dexamethasone. II. Determine the safety and toxicity of this regimen in this patient population.

PROTOCOL OUTLINE: Patients receive oral dexamethasone on days 1-4, 9-12, and 17-20, doxorubicin IV on day 1, and oral thalidomide daily. Treatment repeats every 30 days for 4 courses in the absence of unacceptable toxicity or disease progression.

PROJECTED ACCRUAL: A total of 21-45 patients will be accrued for this study within approximately 1 year.

Eligibility

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

--Prior/Concurrent Therapy--

  • Biologic therapy: Not specified
  • Chemotherapy: No prior chemotherapy for multiple myeloma
  • Endocrine therapy: No more than 1 course of prior pulse dexamethasone; Prior steroids of less than 1 month duration for emergent indications or life-threatening lesions (e.g., hypercalcemia or spinal cord compromise) allowed
  • Radiotherapy: Prior radiotherapy allowed
  • Surgery: Not specified

--Patient Characteristics--

  • Age: 18 and over
  • Performance status: ECOG 0-3
  • Life expectancy: More than 4 months
  • Hematopoietic: Absolute granulocyte count at least 1,500/mm3*; Platelet count at least 100,000/mm3* *Unless due to multiple myeloma
  • Hepatic: Bilirubin no greater than 2.0 mg/dL; ALT and AST no greater than 3 times upper limit of normal (ULN); Alkaline phosphatase no greater than 3 times ULN
  • Renal: Elevated creatinine allowed
  • Cardiovascular: LVEF at least 50% by MUGA or ECHO; No active angina; No myocardial infarction; within the past 6 months
  • Other: Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception at least 4 weeks prior to, during, and for at least 4 weeks after study; No grade II or greater pre-existing neuropathy; No other concurrent or prior active malignancy within the past 2 years except adequately treated non-melanoma skin cancer or carcinoma in situ of the cervix; Prior T1a or T1b prostate cancer (detected incidentally at transurethral resection of prostate (TURP) and comprising less than 5% of resected tissue) allowed if PSA normal since TURP; HIV negative; No AIDS-related illness; No other medical condition that would preclude study

Location Information


New York
      Memorial Sloan-Kettering Cancer Center, New York,  New York,  10021,  United States

Study chairs or principal investigators

Raymond L. Comenzo,  Study Chair,  Memorial Sloan-Kettering Cancer Center   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000068390; MSKCC-00077; NCI-G00-1893
Record last reviewed:  May 2004
Last Updated:  October 13, 2004
Record first received:  January 6, 2001
ClinicalTrials.gov Identifier:  NCT00008242
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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