Isotretinoin Plus Dexamethasone in Treating Patients With Multiple Myeloma

Multiple Myeloma and Plasma Cell Neoplasm Clinical Trial

Official title:

A Phase II Trial of Dexamethasone and 13-cis-Retinoic Acid as First-Line Treatment for Multiple Myeloma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00021359
• Other study ID #: CDR0000068772
• Secondary ID: FCCC-95043NCI-G0
• Status: Completed
• Phase: Phase 2
• First received: July 11, 2001
• Last updated: July 9, 2013
• Start date: August 1999
• Est. completion date: October 2005

Study information

• Verified date: July 2013
• Source: Fox Chase Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: October 2005
• Est. primary completion date: July 2000
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Myeloma
• Multiple Myeloma and Plasma Cell Neoplasm
• Neoplasms, Plasma Cell
• Plasmacytoma

Intervention

Drug:
• dexamethasone

• isotretinoin

Locations

Country	Name	City	State
United States	Bon Secours-Holy Family Health System	Altoona	Pennsylvania
United States	Delaware County Memorial Hospital	Drexel Hill	Pennsylvania
United States	Hunterdon Regional Cancer Center	Flemington	New Jersey
United States	Pinnacle Health Hospitals	Harrisburg	Pennsylvania
United States	Conemaugh Memorial Hospital	Johnstown	Pennsylvania
United States	Kimball Medical Center	Lakewood	New Jersey
United States	Saint Mary Regional Center	Langhorne	Pennsylvania
United States	North Penn Hospital	Lansdale	Pennsylvania
United States	South Jersey Regional Cancer Center	Millville	New Jersey
United States	Fox Chase Cancer Center at Virtua Memorial Hospital Burlington County	Mount Holly	New Jersey
United States	Paoli Memorial Hospital	Paoli	Pennsylvania
United States	Fox Chase Cancer Center	Philadelphia	Pennsylvania
United States	Pottstown Memorial Regional Cancer Center	Pottstown	Pennsylvania
United States	Reading Hospital and Medical Center	Reading	Pennsylvania
United States	Riverview Medical Center - Booker Cancer Center	Red Bank	New Jersey
United States	Community Medical Center	Toms River	New Jersey
United States	St. Francis Medical Center	Trenton	New Jersey
United States	Southern Chester County Medical Center	West Grove	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Fox Chase Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,