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Phase II Evaluation of FTI (R115777) (NSC 702818) in Treatment of Advanced Multiple Myeloma


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Multiple Myeloma and Plasma Cell Neoplasm

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Trial Information

Phase II Evaluation of FTI (R115777) (NSC 702818) in Treatment of Advanced Multiple Myeloma


OBJECTIVES:

- Determine the objective response rate and disease-stabilization rate in patients with
relapsed or refractory multiple myeloma treated with R115777.

- Determine whether the degree of inhibition of FTase activity and farnesylation of
lamin-B, H-RAS, K-RAS, and N-RAS in peripheral blood mononuclear cells (PBMC) and tumor
tissue correlates with tumor response in patients treated with this drug.

- Determine whether the presence of activating RAS mutations in myeloma cells correlates
with disease response in patients treated with this drug.

- Correlate R115777 plasma levels, degree of farnesylation inhibition in PBMC and tumor
tissue, and RAS mutation status with tumor response in patients treated with this drug.

OUTLINE: This is a multicenter study.

Patients receive oral R115777 twice daily on days 1-21. Treatment repeats every 4 weeks in
the absence of disease progression or unacceptable toxicity.

Patients are followed every 4 weeks.

PROJECTED ACCRUAL: A total of 12-42 patients will be accrued for this study within 8-25
months.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Diagnosis of relapsed or refractory multiple myeloma

- Bone marrow plasmacytosis with at least 10% plasma cells, sheets of plasma
cells, or biopsy-proven plasmacytoma

- Myeloma (M)-protein in serum or urine

- Stage IIA or IIIA

- Previously treated with conventional chemotherapy

- Measurable disease

- Serum M-protein component at least 1.0 g/dL OR

- Urine M-protein excretion greater than 200 mg/24 hours

- The following are not considered measurable disease:

- Lytic bone lesions

- Anemia

- Bone marrow plasmacytosis

- Beta-2 microglobulin in serum

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/mm^3

Hepatic:

- Bilirubin no greater than 2 mg/dL

- AST or ALT no greater than 2 times upper limit of normal (ULN)

Renal:

- Creatinine no greater than 1.5 times ULN

- Calcium no greater than 12 mg/dL

Other:

- Capable of swallowing intact tablets

- No other life-threatening illness unrelated to tumor

- No concurrent serious infection

- No other active or invasive malignancy within the past 3 years except nonmelanoma
skin cancer

- No peripheral neuropathy grade 3 or greater

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use 2 forms of effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- At least 2 weeks since prior immunologic agents

- Prior thalidomide allowed

- No concurrent immunotherapy

Chemotherapy:

- See Disease Characteristics

- At least 3 weeks since prior cytotoxic chemotherapy

- No other concurrent cytotoxic therapy

Endocrine therapy:

- At least 2 weeks since prior high-dose corticosteroids

- No concurrent corticosteroids

- No concurrent hormonal therapy

Radiotherapy:

- At least 3 weeks since prior radiotherapy

- No concurrent radiotherapy

Surgery:

- Not specified

Other:

- Concurrent pamidronate or other bisphosphonates allowed

- No concurrent anticancer therapy

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Melissa Alsina, MD

Investigator Role:

Study Chair

Investigator Affiliation:

H. Lee Moffitt Cancer Center and Research Institute

Authority:

United States: Federal Government

Study ID:

CDR0000068759

NCT ID:

NCT00021203

Start Date:

January 2001

Completion Date:

Related Keywords:

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

Name

Location

Mayo Clinic Cancer CenterRochester, Minnesota  55905
H. Lee Moffitt Cancer Center and Research InstituteTampa, Florida  33612