Clinical Trial: Phase II Study of R115777 in Patients With Relapsed or Refractory Multiple Myeloma

This study has been completed.

Sponsors and Collaborators: National Cancer Institute (NCI)
H. Lee Moffitt Cancer Center and Research Institute
Information provided by: National Cancer Institute (NCI)

Purpose

Patient Abstract available in the near future.

Condition Treatment or Intervention Phase
stage II multiple myeloma
stage III multiple myeloma
refractory plasma cell neoplasm
 Drug: R115777
Phase II

MedlinePlus related topics:  Immune System and Disorders;   Lymphatic Diseases;   Multiple Myeloma

Study Type: Interventional
Study Design: Treatment

Further Study Details: 

OBJECTIVES: I. Determine the rate of objective response and disease stabilization in patients with relapsed or refractory multiple myeloma treated with R115777. II. Determine whether the degree of inhibition of FTase activity and farnesylation of lamin-B, H-, K-, and N-RAS in peripheral blood mononuclear cells and tumor tissue correlates with tumor response in patients treated with this regimen. III. Determine whether the presence of activating RAS mutations in myeloma cells predicts treatment response in patients treated with this regimen. IV. Correlate R115777 plasma levels and RAS mutation status with tumor response in patients treated with this regimen.

PROTOCOL OUTLINE: Patients receive oral R115777 twice daily on days 1-21. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients are followed for at least 30 days.

PROJECTED ACCRUAL: Approximately 12-42 patients will be accrued for this study within 25 months.

Eligibility

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

  • Diagnosis of relapsed or refractory multiple myeloma confirmed by the presence of the following: Bone marrow plasmacytosis with at least 10 percent plasma cells; Sheets of plasma cells OR Biopsy-proven plasmacytoma
  • Documentation of at least one of the following criteria: Serum myeloma (M)-protein component at least 1.0 g/dL by serum protein electrophoresis; Urine M-protein excretion more than 200 mg/24 hours by urine protein electrophoresis
  • Stage IIA or IIIA disease
  • Measurable disease The following are not considered measurable disease: Lytic bone lesions; Anemia; Bone marrow plasmacytosis; Beta-2 microglobulin in serum
  • Previously treated with conventional chemotherapy; Progressing or relapsing disease at time of study

--Prior/Concurrent Therapy--

  • Biologic therapy: Prior thalidomide allowed; At least 14 days since prior immunologic agents; No concurrent immunologic agents
  • Chemotherapy: See Disease Characteristics; At least 3 weeks since prior cytotoxic chemotherapy; No other concurrent cytotoxic therapy
  • Endocrine therapy: At least 14 days since prior high-dose corticosteroids; No concurrent hormonal therapy; No concurrent corticosteroids
  • Radiotherapy: At least 3 weeks since prior radiotherapy and recovered; No concurrent radiotherapy
  • Surgery: Not specified
  • Other: No other concurrent cancer therapy; Concurrent pamidronate or other bisphosphonates allowed

--Patient Characteristics--

  • Age: 18 and over
  • Performance status: ECOG 0-3
  • Life expectancy: More than 8 weeks
  • Hematopoietic: Absolute neutrophil count at least 1,000/mm3
  • Hepatic: AST or ALT no greater than 2 times upper limit of normal (ULN); Bilirubin no greater than 2 mg/dL
  • Renal: Creatinine no greater than 1.5 times ULN; Calcium no greater than 12 mg/dL
  • Other: Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception; Capable of swallowing intact study medication tablets; No concurrent serious infection; No grade 3 or greater peripheral neuropathy; No life-threatening illness unrelated to tumor; No other active or invasive cancer within the past 3 years except nonmelanoma skin cancer

Location Information

Study chairs or principal investigators

William S. Dalton,  Study Chair,  H. Lee Moffitt Cancer Center and Research Institute   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000068513; MCC-12137; NCI-2030; MCC-IRB-5442
Record last reviewed:  May 2004
Last Updated:  October 13, 2004
Record first received:  March 3, 2001
ClinicalTrials.gov Identifier:  NCT00012350
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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