Back to resultsIsotretinoin Plus Dexamethasone in Treating Patients With Multiple Myeloma
Primary Purpose
Multiple Myeloma and Plasma Cell Neoplasm
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
dexamethasone
isotretinoin
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Myeloma and Plasma Cell Neoplasm focused on measuring stage I multiple myeloma, stage II multiple myeloma, stage III multiple myeloma
Eligibility Criteria
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
Sites / Locations
- Hunterdon Regional Cancer Center
- Kimball Medical Center
- South Jersey Regional Cancer Center
- Fox Chase Cancer Center at Virtua Memorial Hospital Burlington County
- Riverview Medical Center - Booker Cancer Center
- Community Medical Center
- St. Francis Medical Center
- Bon Secours-Holy Family Health System
- Delaware County Memorial Hospital
- Pinnacle Health Hospitals
- Conemaugh Memorial Hospital
- Saint Mary Regional Center
- North Penn Hospital
- Paoli Memorial Hospital
- Fox Chase Cancer Center
- Pottstown Memorial Regional Cancer Center
- Reading Hospital and Medical Center
- Southern Chester County Medical Center
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00021359
First Posted
July 11, 2001
Last Updated
July 9, 2013
Sponsor
Fox Chase Cancer Center
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT00021359
Brief Title
Isotretinoin Plus Dexamethasone in Treating Patients With Multiple Myeloma
Official Title
A Phase II Trial of Dexamethasone and 13-cis-Retinoic Acid as First-Line Treatment for Multiple Myeloma
Study Type
Interventional
2. Study Status
Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
August 1999 (undefined)
Primary Completion Date
July 2000 (Actual)
Study Completion Date
October 2005 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fox Chase Cancer Center
Collaborators
National Cancer Institute (NCI)
4. Oversight
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma and Plasma Cell Neoplasm
Keywords
stage I multiple myeloma, stage II multiple myeloma, stage III multiple myeloma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
17 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
dexamethasone
Intervention Type
Drug
Intervention Name(s)
isotretinoin
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Russell J. Schilder, MD
Organizational Affiliation
Fox Chase Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Hunterdon Regional Cancer Center
City
Flemington
State/Province
New Jersey
ZIP/Postal Code
08822
Country
United States
Facility Name
Kimball Medical Center
City
Lakewood
State/Province
New Jersey
ZIP/Postal Code
08701
Country
United States
Facility Name
South Jersey Regional Cancer Center
City
Millville
State/Province
New Jersey
ZIP/Postal Code
08332
Country
United States
Facility Name
Fox Chase Cancer Center at Virtua Memorial Hospital Burlington County
City
Mount Holly
State/Province
New Jersey
ZIP/Postal Code
08060
Country
United States
Facility Name
Riverview Medical Center - Booker Cancer Center
City
Red Bank
State/Province
New Jersey
ZIP/Postal Code
07701
Country
United States
Facility Name
Community Medical Center
City
Toms River
State/Province
New Jersey
ZIP/Postal Code
08755
Country
United States
Facility Name
St. Francis Medical Center
City
Trenton
State/Province
New Jersey
ZIP/Postal Code
08629
Country
United States
Facility Name
Bon Secours-Holy Family Health System
City
Altoona
State/Province
Pennsylvania
ZIP/Postal Code
16602
Country
United States
Facility Name
Delaware County Memorial Hospital
City
Drexel Hill
State/Province
Pennsylvania
ZIP/Postal Code
19026
Country
United States
Facility Name
Pinnacle Health Hospitals
City
Harrisburg
State/Province
Pennsylvania
ZIP/Postal Code
17105-8700
Country
United States
Facility Name
Conemaugh Memorial Hospital
City
Johnstown
State/Province
Pennsylvania
ZIP/Postal Code
15905
Country
United States
Facility Name
Saint Mary Regional Center
City
Langhorne
State/Province
Pennsylvania
ZIP/Postal Code
19047
Country
United States
Facility Name
North Penn Hospital
City
Lansdale
State/Province
Pennsylvania
ZIP/Postal Code
19446-1200
Country
United States
Facility Name
Paoli Memorial Hospital
City
Paoli
State/Province
Pennsylvania
ZIP/Postal Code
19301-1792
Country
United States
Facility Name
Fox Chase Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
Facility Name
Pottstown Memorial Regional Cancer Center
City
Pottstown
State/Province
Pennsylvania
ZIP/Postal Code
19464
Country
United States
Facility Name
Reading Hospital and Medical Center
City
Reading
State/Province
Pennsylvania
ZIP/Postal Code
19612-6052
Country
United States
Facility Name
Southern Chester County Medical Center
City
West Grove
State/Province
Pennsylvania
ZIP/Postal Code
19390
Country
United States
12. IPD Sharing Statement
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Isotretinoin Plus Dexamethasone in Treating Patients With Multiple Myeloma
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