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COMPLETED
NCT01242930
PHASE2

Open Label Study With Imetelstat to Determine Effect of Imetelstat in Patients w/ Previously Treated Multiple Myeloma

Sponsor: Geron Corporation

View on ClinicalTrials.gov

Summary

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.

Official title: A Phase II Trial to Determine the Effect of Imetelstat (GRN163L) on Patients With Previously Treated Multiple Myeloma

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

13

Start Date

2010-11

Completion Date

2014-11

Last Updated

2026-06-17

Healthy Volunteers

No

Interventions

DRUG

Imetelstat (7.5 mg/kg)

Imetelstat 7.5 mg/kg as a 2-hour intravenous infusion (± 10 minutes) on Days 1 and 8 of a 28-day cycle; the Day 8 dose will be omitted in patients with a prior history of bone marrow or stem cell transplant.

DRUG

lenalidomide standard of care

Patients who are receiving lenalidomide as maintenance therapy upon enrollment as part of their treatment regimen may remain on this therapy during trial participation, provided that they have received this treatment for a minimum of 3 months and demonstrate evidence of stabilization of their response.

DRUG

Imetelstat (9.4 mg/kg)

Imetelstat 9.4 mg/kg as a 2-hour intravenous infusion (± 10 minutes) on Days 1 and 8 of a 28-day cycle; the Day 8 dose will be omitted in patients with a prior history of bone marrow or stem cell transplant.

Locations (2)

University of Maryland Medical Center - M & S Greenebaum Cancer Center

Baltimore, Maryland, United States

Sidney Kimmel Cancer Center Johns Hopkins Hospital

Baltimore, Maryland, United States