Open Label Study With Imetelstat to Determine Effect of Imetelstat in Patients w/ Previously Treated Multiple Myeloma
This is an open label Phase II study to determine the rate of improvement in response of patients with previously treated multiple myeloma to imetelstat alone or in combination with lenalidomide maintenance therapy. This study will include multiple myeloma patients who either have achieved disease stabilization or who have achieved at least a partial response (PR) but failed to achieve a complete response (CR) after cytoreductive therapy for multiple myeloma; ie, have detectable but non-progressing disease and will most likely relapse.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Trial to Determine the Effect of Imetelstat (GRN163L) on Patients With Previously Treated Multiple Myeloma|
- Rate of Improvement in Response [ Time Frame: From time of first dose (Cycle 1 day 1) through end of study period (12 mos. after last participant is enrolled) ] [ Designated as safety issue: No ]To determine the rate of improvement in response in patients with previously treated multiple myeloma following treatment with imetelstat alone or in combination wtih lenalidomide maintenance therapy. Response will be assessed using the International Uniform Response Criteria for Multiple Myeloma (IURCMM).
- Progression-free Survival (PFS) [ Time Frame: From time of first dose (Cycle 1 day 1) through end of study (12 mos. after last participant is enrolled) ] [ Designated as safety issue: No ]As assessed from Cycle 1 Day 1 to first evidence of PD as defined by IURCMM, or death, whichever occurs first.
- Safety and Tolerability [ Time Frame: From time of first dose (Cycle 1 day 1) through end of study (12 mos. after last participant is enrolled) ] [ Designated as safety issue: Yes ]
The safety and tolerability of imetelstat will be assessed by the incidence, nature, relatedness and severity of adverse events, laboratory abnormalities and vital signs.
Patients who develop Grade 3 or 4 cytopenias (other than lyphophenia and/or leukopenia alon) will receive addiontal safety monitoring for reversibility.
|Study Start Date:||November 2010|
|Estimated Study Completion Date:||December 2013|
|Estimated Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
Experimental: Imetelstat plus standard of care
9.4 mg/kg over a 2 hour IV Infusion on Day 1 and Day 8 of a 28-day cycle.
Drug: Standard of Care
Standard of Care
|United States, Maryland|
|Sidney Kimmel Cancer Center Johns Hopkins Hospital|
|Baltimore, Maryland, United States, 21231|
|University of Maryland Medical Center - M & S Greenebaum Cancer Center|
|Baltimore, Maryland, United States, 21201|
|Study Director:||Ted Shih, PharmD||Geron Corporation|
|Principal Investigator:||Carol Ann Huff, M.D.||Sidney Kimmel Cancer Center at Johns Hopkins Hospital|