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Isotretinoin Plus Dexamethasone in Treating Patients With Multiple Myeloma

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ClinicalTrials.gov Identifier: NCT00021359
Recruitment Status : Completed
First Posted : March 11, 2004
Last Update Posted : July 10, 2013
Information provided by (Responsible Party):

July 11, 2001
March 11, 2004
July 10, 2013
August 1999
July 2000   (Final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00021359 on ClinicalTrials.gov Archive Site
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Isotretinoin Plus Dexamethasone in Treating Patients With Multiple Myeloma
A Phase II Trial of Dexamethasone and 13-cis-Retinoic Acid as First-Line Treatment for Multiple Myeloma

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with dexamethasone may be an effective treatment for multiple myeloma.

PURPOSE: Phase II trial to study the effectiveness of combining isotretinoin and dexamethasone in treating patients who have multiple myeloma.

OBJECTIVES: I. Determine the response rate and duration of response of patients with multiple myeloma treated with dexamethasone and isotretinoin. II. Determine the toxicity of this regimen in these patients. III. Correlate the changes in serum interleukin (IL)-6, IL-6R, and C-reactive and IL-6R expression on plasma cells in the bone marrow with response in patients treated with this regimen.

OUTLINE: Patients receive oral dexamethasone on days 1-4, 9-12, and 17-20 and oral isotretinoin daily. Treatment repeats every 5 weeks for at least 2 courses in the absence of disease progression, insufficient response, or unacceptable toxicity. Patients achieving adequate response continue treatment for 2 courses after achieving a plateau of monoclonal protein, for a minimum of 6 courses total.

PROJECTED ACCRUAL: A total of 18-36 patients will be accrued for this study within 3 years.

Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Multiple Myeloma and Plasma Cell Neoplasm
  • Drug: dexamethasone
  • Drug: isotretinoin
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
October 2005
July 2000   (Final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS: Histologically confirmed multiple myeloma Elevated monoclonal protein in serum and/or urine

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: WBC at least 3,000/mm3* Platelet count at least 75,000/mm3* *Unless secondary to multiple myeloma involvement of the bone marrow Hepatic: Bilirubin less than 1.5 mg/dL Transaminase less than 2 times normal Renal: Creatinine less than 2.0 mg/dL No overt renal insufficiency Cardiovascular: No congestive heart failure No myocardial infarction within the past 6 months No significant arrhythmia or poorly controlled hypertension Pulmonary: No severe pulmonary disease Other: Triglycerides normal No other severe medical illness No active peptic ulcer disease No brittle insulin-dependent diabetes No severe depression or other psychiatric illness No active infection No history of severe ethanol or drug abuse Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: Prior palliative radiotherapy allowed Surgery: At least 3 weeks since prior major surgery

Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
FCCC-95043 ( Other Identifier: Fox Chase Cancer Center )
NCI-G01-1985 ( Other Grant/Funding Number: NCI )
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Fox Chase Cancer Center
Fox Chase Cancer Center
National Cancer Institute (NCI)
Study Chair: Russell J. Schilder, MD Fox Chase Cancer Center
Fox Chase Cancer Center
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP