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| Sponsor: | Geron Corporation |
|---|---|
| Information provided by (Responsible Party): | Geron Corporation |
| ClinicalTrials.gov Identifier: | NCT01242930 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Multiple Myeloma |
Drug: Standard of Care |
Phase 2 |
| Study Type: | Interventional |
| 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 |
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.
| Estimated Enrollment: | 48 |
| Study Start Date: | November 2010 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Willing and able to sign an informed consent Male or female, 18 years or older Confirmed diagnosis of multiple myeloma (secretory disease) by International Myeloma Working Group Diagnostic Criteria
Patients must meet one of the following criteria:
o Previously treated patients with multiple myeloma who achieved at least stable disease but who have failed to achieve a complete response (CR) after a minimum of one cytoreductive therapy for multiple myeloma and have detectable but non-progressing disease. Patients must have received at least one proteasome inhibitor (eg, bortezomib) or one immunomodulatory agent (eg, thalidomide or lenalidomide) or both.
Patients receiving lenalidomide as maintenance therapy may continue to receive this therapy provided that the patient has been on this maintenance therapy for a minimum of 3 months and has evidence of disease stabilization.
Disease stabilization will be defined as an M protein that varies ≤ 25% over the three measurements or remains under 0.5 g/dL whichever is smaller.
ECOG performance status 0-2 Life expectancy ≥ 3 months
Laboratory criteria (within 14 days of first study drug administration):
Must have fully recovered from any previous cancer treatments and/or major surgery.
Women of childbearing potential must have a negative serum pregnancy test and agree to use effective birth control (two reliable forms of contraception) during and for at least 12 weeks after the last treatment.
Males must agree to use effective birth control for themselves or their partner during and for 12 weeks after the last treatment with imetelstat. For those patients receiving lenolidomide, males must use latex condom during sexual contact with women of childbearing potential even if they have undergone a successful vasectomy.
Exclusion Criteria:
Women who are pregnant or breast feeding Prior radioimmunotherapy. Known intracranial disease or epidural disease. Patients with lytic lesions of the cranium or spine secondary to myeloma are eligible to enroll.
Clinically significant cardiovascular disease or condition including:
Symptomatic hyperviscosity syndrome. Any other cancer therapy including chemotherapy, monoclonal antibody, signal transduction inhibitor, immunotherapy, glucocorticoid (except topical or as premedication), thalidomide within 3 weeks prior to first study drug administration.
Investigational therapy within 4 weeks prior to first study drug administration.
Major surgery within 4 weeks prior to first study drug administration (central line placement is allowed) Anti-platelet therapy within 2 weeks prior to first study drug administration, other than low dose aspirin prophylaxis therapy.
Full dose anticoagulation. Prophylactic low dose administration for management of IV access devices is allowed.
Known positive serology for human immunodeficiency virus (HIV. Any other severe, acute, or chronic medical or psychiatric condition, laboratory abnormality, or difficulty complying with protocol requirements that may increase the risk associated with study participation or study drug administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for this study
Contacts and Locations| Contact: Martha Blaney, PharmD. | info@geron.com | |
| Contact: Christina Ayran | info@geron.com |
| United States, Maryland | |
| Sidney Kimmel Cancer Center Johns Hopkins Hospital | Recruiting |
| Baltimore, Maryland, United States, 21231 | |
| Contact: K Rogers, RN 443-287-0388 Krogers7@jhmi.edu | |
| Principal Investigator: Carol Ann Huff, M.D. | |
| University of Maryland Medical Center - M & S Greenebaum Cancer Center | Recruiting |
| Baltimore, Maryland, United States, 21201 | |
| Contact: Ashraf Z. Badros, M.D., Ch.B. 800-492-5538 | |
| Contact: Sunita Philip, MPH, CCRP | |
| Principal Investigator: Ashraf Z. Badros, M.D., Ch.B. | |
| Study Director: | Stephen Kelsey, MD, FRCP, FRC Path. | Geron Corporation |
| Principal Investigator: | Carol Ann Huff, M.D. | Sidney Kimmel Cancer Center at Johns Hopkins Hospital |
More Information
| Responsible Party: | Geron Corporation |
| ClinicalTrials.gov Identifier: | NCT01242930 History of Changes |
| Other Study ID Numbers: | CP14B013 |
| Study First Received: | November 16, 2010 |
| Last Updated: | March 2, 2012 |
| Health Authority: | United States: Food and Drug Administration |
|
imetelstat imetelstat sodium GRN163L telomerase inhibitor |
telomerase inhibition multiple myeloma myeloma myeloma progenitor cells |
|
Multiple Myeloma Neoplasms, Plasma Cell Neoplasms by Histologic Type Neoplasms Hemostatic Disorders Vascular Diseases Cardiovascular Diseases |
Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders Lymphoproliferative Disorders Immunoproliferative Disorders Immune System Diseases |