Search Clinical Trials
 
By Condition
 
By Location (USA)
 
By Location (Other)
 
By Sponsor
 
Resources
 
Privacy Policy
 
About Us
Disclaimer
Phase II Study of R115777 in Patients With Relapsed or Refractory Multiple Myeloma Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified health advice, visits or treatment with a real mD. We are not doctors. Always consult your doctor about Phase II Study of R115777 in Patients With Relapsed or Refractory Multiple Myeloma conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Phase II Study of R115777 in Patients With Relapsed or Refractory Multiple Myeloma Clinical research trials and Phase II Study of R115777 in Patients With Relapsed or Refractory Multiple Myeloma healthcare trials happen in many of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new drugs. The purpose of the studies / projects is to solve particular human medical questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to discover cures for all varieties of conditions, such as Phase II Study of R115777 in Patients With Relapsed or Refractory Multiple Myeloma. Phase II Study of R115777 in Patients With Relapsed or Refractory Multiple Myeloma Clinical Trials and other clinical trials allow volunteers to have health treatment alternatives before they are available to the masses. Some times the human subjects obtain treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Phase II Study of R115777 in Patients With Relapsed or Refractory Multiple Myeloma clinical trial. Test subjects oftentimes receive the most effective healthcare possible for their Phase II Study of R115777 in Patients With Relapsed or Refractory Multiple Myeloma condition. Dangers are a reality, however, and may include extra or frequent physician visits, healthcare dangers (possibly life-jeopardising), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials patients.

Home > "P" Clinical Trials Conditions > Phase II Study of R115777 in Patients With Relapsed or Refractory Multiple Myeloma

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



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

For Condition: stage 3 multiple myeloma,stage 2 multiple myeloma,refractory plasma cell neoplasm
Status: Completed
Sponsor(s): National Cancer Institute (NCI) , H. Lee Moffitt Cancer Center and Research Institute
Synopsis: Patient Abstract available in the near future.
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:
Study Type:  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: 
Protocol Entry 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
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
WilliamDalton,  Study Chair,  H. Lee Moffitt Cancer Center and Research Institute


Additional Information:
Study ID Numbers:  CDR0000068513;  MCC-12137,MCC-IRB-5442,NCI-2030
Study Start Date: 
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00012350

Other Stage 3 Multiple Myeloma Studies:
1. CC-5013 in Treating Patients With Advanced Multiple Myeloma

2. Combination Chemotherapy, Peripheral Stem Cell Transplantation, Biological Therapy, Pamidronate and Thalidomide in Treating Patients With Multiple Myeloma

3. High-Dose Melphalan and Autologous Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma or Primary Systemic Amyloidosis

4. Rituximab in Treating Patients With Multiple Myeloma

5. Total-Body Irradiation, Busulfan, and Interferon alfa Followed by Peripheral Stem Cell or Bone Marrow Transplantation in Treating Patients With Multiple Myeloma

Related Studies:

Other stage 3 multiple myeloma Clinical Trials
Other Clinical Trials
Other Clinical Trials

Phase II Study of R115777 in Patients With Relapsed or Refractory Multiple Myeloma
Modify your Search

  Other stage 3 multiple myeloma Clinical Trials
  Other Clinical Trials
  Other Clinical Trials


Warning: include(/var/www/cgi-bin/traxis/counter.php) [function.include]: failed to open stream: No such file or directory in /home/cts/domains/clinicaltrialssearch.org/public_html/index.php on line 103

Warning: include() [function.include]: Failed opening '/var/www/cgi-bin/traxis/counter.php' for inclusion (include_path='.:/usr/local/lib/php') in /home/cts/domains/clinicaltrialssearch.org/public_html/index.php on line 103