Safety and Dose Study of GRN163L Administered to Treat Patients With Refractory or Relapsed Multiple Myeloma
This study has been completed.
Sponsor:
Geron Corporation
Information provided by (Responsible Party):
Geron Corporation
ClinicalTrials.gov Identifier:
NCT00594126
First received: January 3, 2008
Last updated: January 24, 2012
Last verified: January 2012
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Purpose
The purpose of this study is to determine the safety and the maximum tolerated dose (MTD) of GRN163L when administered to patients with refractory or relapsed multiple myeloma.
| Condition | Intervention | Phase |
|---|---|---|
|
Multiple Myeloma |
Drug: Imetelstat Sodium (GRN163L) |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase 1 Sequential Cohort, Dose Escalation Trial to Determine the Safety, Tolerability, and Maximum Tolerated Dose of GRN163L in Patients With Refractory or Relapsed Multiple Myeloma |
Resource links provided by NLM:
Further study details as provided by Geron Corporation:
Primary Outcome Measures:
- Safety and MTD [ Time Frame: First 3 weeks ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- PK, PD, and efficacy [ Time Frame: Baseline to end of treatment ] [ Designated as safety issue: No ]
| Enrollment: | 20 |
| Study Start Date: | November 2007 |
| Study Completion Date: | July 2011 |
| Primary Completion Date: | July 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1
3+3 cohort dose escalation
|
Drug: Imetelstat Sodium (GRN163L)
25% dose escalation infused over 2 hours weekly
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Confirmed diagnosis of multiple myeloma (either secretory or nonsecretory disease)
- Relapsed or refractory disease
- At least two prior treatment regimens
- 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%
Exclusion Criteria:
- Prior allogeneic bone marrow transplant, including syngeneic transplant
- Known intracranial disease or epidural disease
- 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
- Symptomatic hyperviscosity syndrome
- Any other cancer therapy within 3 weeks prior to study, except for mitomycin C, nitrosoureas, or high-dose chemotherapy with stem cell support 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00594126
Locations
| United States, Maryland | |
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University | |
| Baltimore, Maryland, United States, 21231 | |
| United States, Massachusetts | |
| Dana Farber Cancer Institute | |
| Boston, Massachusetts, United States, 02115 | |
| United States, New York | |
| Roswell Park Cancer Institute | |
| Buffalo, New York, United States, 14263 | |
Sponsors and Collaborators
Geron Corporation
Investigators
| Study Director: | Steve Kelsey, MD | Geron Corporation |
More Information
Additional Information:
No publications provided
| Responsible Party: | Geron Corporation |
| ClinicalTrials.gov Identifier: | NCT00594126 History of Changes |
| Other Study ID Numbers: | CP14A004 |
| Study First Received: | January 3, 2008 |
| Last Updated: | January 24, 2012 |
| Health Authority: | United States: Food and Drug Administration United States: Institutional Review Board |
Keywords provided by Geron Corporation:
|
Myeloma Multiple Myeloma Relapsed Multiple Myeloma Refractory Multiple Myeloma Relapsed or Refractory Multiple Myeloma |
Additional relevant MeSH terms:
|
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 |
ClinicalTrials.gov processed this record on May 19, 2013