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Trial record 23 of 2513 for:    "Plasma Cell Neoplasm"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00008242
Recruitment Status : Completed
First Posted : May 4, 2004
Last Update Posted : March 7, 2013
National Cancer Institute (NCI)
Information provided by:
Memorial Sloan Kettering Cancer Center

Brief Summary:

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 or disease Intervention/treatment Phase
Multiple Myeloma and Plasma Cell Neoplasm Drug: dexamethasone Drug: doxorubicin hydrochloride Drug: thalidomide Phase 2

Detailed Description:

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.

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.

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Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: A Phase II Clinical Trial Of Thalidomide, Adramycin And Dexamethasone (TAD) As Initial Therapy For The Treatment Of Multiple Myeloma
Study Start Date : August 2000
Actual Primary Completion Date : January 2006
Actual Study Completion Date : January 2006

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

DISEASE CHARACTERISTICS: Histologically confirmed multiple myeloma Stage II disease Symptomatic due to progressive disease OR Stage III disease No stage I multiple myeloma or smoldering myeloma

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00008242

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United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
National Cancer Institute (NCI)
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Study Chair: Raymond L. Comenzo, MD Memorial Sloan Kettering Cancer Center

Publications of Results:
Layout table for additonal information Identifier: NCT00008242     History of Changes
Other Study ID Numbers: 00-077
P30CA008748 ( U.S. NIH Grant/Contract )
First Posted: May 4, 2004    Key Record Dates
Last Update Posted: March 7, 2013
Last Verified: March 2013

Keywords provided by Memorial Sloan Kettering Cancer Center:
stage II multiple myeloma
stage III multiple myeloma

Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone acetate
Liposomal doxorubicin
BB 1101
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists