Safety and Dose Study of GRN163L and Velcade to Treat Patients With Refractory or Relapsed Myeloma
- Registration Number
- NCT00718601
- Lead Sponsor
- Geron Corporation
- Brief Summary
The purpose of this study is to determine safety and the maximum tolerated dose (MTD) of GRN163L and Velcade with and without Decadron when administered to patients with refractory or relapsed multiple myeloma.
- Detailed Description
GRN163L is a telomerase template antagonist with in vitro and in vivo activity in a variety of tumor model systems. Telomerase is an enzyme that is active primarily in tumor cells and is crucial for the indefinite growth of tumor cells. Inhibition of telomerase may result in antineoplastic effects.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
- Confirmed diagnosis of multiple myeloma (either secretory or nonsecretory disease)
- Relapsed or refractory disease
- ECOG performance status 0-2
- Adequate hepatic/renal function and platelet count
- If previously treated with an anthracycline, anthracenedione, or trastuzumab, must have left ventricular ejection fraction > 50%
- Fully recovered from any previous cancer treatments and/or major surgery
Exclusion Criteria
- Prior allogeneic bone marrow transplant, including syngeneic transplant
- Bone marrow transplant within 12 weeks prior to study
- Known intracranial disease or epidural disease
- Inability to tolerate Velcade
- Inability to tolerate Decadron
- Prior malignancy (within the last 3 years)
- Clinically significant cardiovascular disease or condition
- Active or chronically recurrent bleeding (eg, active peptic ulcer disease
- Prolongation of PT or aPTT > the ULN or fibrinogen < the LLN
- Clinically relevant active infection
- Serious co-morbid medical conditions, including cirrhosis and chronic obstructive or chronic restrictive pulmonary disease
- Any other cancer therapy within 4 weeks prior to study, with nitrosourea within 6 weeks prior to study
- Investigational therapy within 4 weeks prior to study
- Anti-platelet therapy within 2 weeks prior to study, other than low dose aspirin prophylaxis therapy and low dose heparin administration for management of IV access devices
- Radiation therapy within 4 weeks prior to study
- Major surgery within 4 weeks prior to study
- Active autoimmune disease requiring immunosuppressive therapy
- Known positive serology for HIV
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 Imetelstat Sodium (GRN163L) 3+3 cohort dose escalation
- Primary Outcome Measures
Name Time Method Maximum tolerated dose First 3 weeks
- Secondary Outcome Measures
Name Time Method Safety, PK and efficacy Baseline to 28 days after last dose of treatment
Trial Locations
- Locations (3)
Karmanos Cancer Center
🇺🇸Detroit, Michigan, United States
St. Vincent's Comprehensive Cancer Center
🇺🇸New York City, New York, United States
Fred Hutchinson Cancer Research Center
🇺🇸Seattle, Washington, United States