Safety and Dose Study of GRN163L Administered to Treat Patients With Refractory or Relapsed Multiple Myeloma
Primary Purpose
Multiple Myeloma
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Imetelstat Sodium (GRN163L)
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Myeloma focused on measuring Myeloma, Multiple Myeloma, Relapsed Multiple Myeloma, Refractory Multiple Myeloma, Relapsed or Refractory Multiple Myeloma
Eligibility 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
Sites / Locations
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University
- Dana Farber Cancer Institute
- Roswell Park Cancer Institute
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
1
Arm Description
3+3 cohort dose escalation
Outcomes
Primary Outcome Measures
Safety and MTD
Secondary Outcome Measures
PK, PD, and efficacy
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00594126
Brief Title
Safety and Dose Study of GRN163L Administered to Treat Patients With Refractory or Relapsed Multiple Myeloma
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
July 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Geron Corporation
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
Myeloma, Multiple Myeloma, Relapsed Multiple Myeloma, Refractory Multiple Myeloma, Relapsed or Refractory Multiple Myeloma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Other
Arm Description
3+3 cohort dose escalation
Intervention Type
Drug
Intervention Name(s)
Imetelstat Sodium (GRN163L)
Intervention Description
25% dose escalation infused over 2 hours weekly
Primary Outcome Measure Information:
Title
Safety and MTD
Time Frame
First 3 weeks
Secondary Outcome Measure Information:
Title
PK, PD, and efficacy
Time Frame
Baseline to end of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steve Kelsey, MD
Organizational Affiliation
Geron Corporation
Official's Role
Study Director
Facility Information:
Facility Name
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21231
Country
United States
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.geron.com
Description
Related Info
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Safety and Dose Study of GRN163L Administered to Treat Patients With Refractory or Relapsed Multiple Myeloma
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