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


Phase 2
18 Years
N/A
Not Enrolling
Both
Multiple Myeloma and Plasma Cell Neoplasm

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Trial Information

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

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Russell J. Schilder, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Fox Chase Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000068772

NCT ID:

NCT00021359

Start Date:

August 1999

Completion Date:

October 2005

Related Keywords:

  • Multiple Myeloma and Plasma Cell Neoplasm
  • stage I multiple myeloma
  • stage II multiple myeloma
  • stage III multiple myeloma
  • Neoplasms
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Plasmacytoma

Name

Location

Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111
Community Medical CenterToms River, New Jersey  08755
St. Francis Medical CenterTrenton, New Jersey  08629
Delaware County Memorial HospitalDrexel Hill, Pennsylvania  19026
Reading Hospital and Medical CenterReading, Pennsylvania  19612-6052
South Jersey Regional Cancer CenterMillville, New Jersey  08332
Fox Chase Cancer Center at Virtua Memorial Hospital Burlington CountyMount Holly, New Jersey  08060
Hunterdon Regional Cancer CenterFlemington, New Jersey  08822
Kimball Medical CenterLakewood, New Jersey  08701
Riverview Medical Center - Booker Cancer CenterRed Bank, New Jersey  07701
Saint Mary Regional CenterLanghorne, Pennsylvania  19047
North Penn HospitalLansdale, Pennsylvania  19446-1200
Paoli Memorial HospitalPaoli, Pennsylvania  19301-1792
Pinnacle Health HospitalsHarrisburg, Pennsylvania  17105-8700
Conemaugh Memorial HospitalJohnstown, Pennsylvania  15905
Pottstown Memorial Regional Cancer CenterPottstown, Pennsylvania  19464
Bon Secours-Holy Family Health SystemAltoona, Pennsylvania  16602
Southern Chester County Medical CenterWest Grove, Pennsylvania  19390