Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Isotretinoin Plus Dexamethasone in Treating Patients With Multiple Myeloma

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	18 and over	NCI	FCCC-95043 NCI-G01-1985, NCT00021359

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.

Entry Criteria

Disease Characteristics:

Histologically confirmed multiple myeloma

Elevated monoclonal protein in serum and/or urine

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

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

Expected Enrollment

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

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.

Trial Contact Information

Trial Lead Organizations

Fox Chase Cancer Center - Philadelphia

Russell Schilder, MD, Protocol chair		Ph: 215-728-3545; 888-369-2427 Email: russell.schilder@fccc.edu

Registry Information
Official Title		A Phase II Trial of Dexamethasone and 13-cis-Retinoic Acid as First-Line Treatment for Multiple Myeloma
Trial Start Date		1999-08-27
Registered in ClinicalTrials.gov		NCT00021359
Date Submitted to PDQ		2001-05-29
Information Last Verified		2002-01-01
NCI Grant/Contract Number		P30-CA06927

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