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


Phase 2
18 Years
N/A
Not Enrolling
Both
Multiple Myeloma

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Trial Information

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


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.

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.

Inclusion 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

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Eastern Cooperative Oncology
Group (ECOG) 0-3 Life expectancy: More than 8 weeks Hematopoietic: Absolute neutrophil
count at least 1,000/mm^3 Hepatic: aspartate aminotransferase (AST) or alanine
transaminase (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

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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective Response Rate (ORR)

Outcome Description:

The primary end point of the study is to determine the rate of objective response and disease stabilization. Responses were to be defined according to modified Southwest Oncology Group (SWOG) criteria. Disease progression was defined as a 25% increase in the serum M-component confirmed by a second measurement obtained within 1 to 4 weeks of the first measurement, or an increase in the 24-hour urine M-component by more than 50%, confirmed by a second measurement. Other criteria for disease progression included the need to administer radiotherapy, new lytic bone lesions, enlargement of existing bone lesions, or new soft tissue plasmacytomas.

Outcome Time Frame:

26 months

Safety Issue:

No

Principal Investigator

Melissa Alsina, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

H. Lee Moffitt Cancer Center and Research Institute

Authority:

United States: Food and Drug Administration

Study ID:

MCC-12516

NCT ID:

NCT00012350

Start Date:

January 2001

Completion Date:

January 2010

Related Keywords:

  • Multiple Myeloma
  • refractory multiple myeloma
  • stage II multiple myeloma
  • stage III multiple myeloma
  • plasma cell neoplasm
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Name

Location
H. Lee Moffitt Cancer Center and Research Institute Tampa, Florida  33612