Safety and Dose Study of GRN163L and Velcade to Treat Patients With Refractory or Relapsed Myeloma
This study has been completed.
Sponsor:
Geron Corporation
Information provided by (Responsible Party):
Geron Corporation
ClinicalTrials.gov Identifier:
NCT00718601
First received: July 16, 2008
Last updated: January 24, 2012
Last verified: January 2011
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Purpose
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.
| 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 |
| Official Title: | A Phase I Study of GRN163L in Combination With Bortezomib and Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma |
Resource links provided by NLM:
Further study details as provided by Geron Corporation:
Primary Outcome Measures:
- Maximum tolerated dose [ Time Frame: First 3 weeks ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Safety, PK and efficacy [ Time Frame: Baseline to 28 days after last dose of treatment ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 40 |
| Study Start Date: | July 2008 |
| Study Completion Date: | October 2011 |
| Primary Completion Date: | October 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 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
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00718601
Locations
| United States, Michigan | |
| Karmanos Cancer Center | |
| Detroit, Michigan, United States, 48201 | |
| United States, New York | |
| St. Vincent's Comprehensive Cancer Center | |
| New York City, New York, United States, 10011 | |
| United States, Washington | |
| Fred Hutchinson Cancer Research Center | |
| Seattle, Washington, United States, 98109 | |
Sponsors and Collaborators
Geron Corporation
Investigators
| Study Director: | Stephen Kelsey, MD | Geron Corporation |
More Information
Additional Information:
No publications provided
| Responsible Party: | Geron Corporation |
| ClinicalTrials.gov Identifier: | NCT00718601 History of Changes |
| Other Study ID Numbers: | GRN163L CP14A011 |
| Study First Received: | July 16, 2008 |
| Last Updated: | January 24, 2012 |
| Health Authority: | United States: Food and Drug Administration |
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 21, 2013