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

Primary Purpose

Multiple Myeloma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Imetelstat (7.5 mg/kg)
lenalidomide standard of care
Imetelstat (9.4 mg/kg)
Sponsored by
Geron Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Myeloma focused on measuring imetelstat, imetelstat sodium, GRN163L, telomerase inhibitor, telomerase inhibition, multiple myeloma, myeloma, myeloma progenitor cells

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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):

  • ANC ≥ 1000/μL
  • Platelet count ≥ 50 x 103/μL (without transfusion support within 2 weeks prior to first study drug administration)
  • Hemoglobin ≥ 8.0 g/dL
  • Serum creatinine ≤ 3 x the upper limit of normal (ULN)
  • AST (SGOT) and ALT (SGPT) ≤ 2.5 x the upper limit of normal (ULN), unless due to disease.

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:

  • Congestive heart failure (CHF) requiring therapy
  • Need for antiarrhythmic therapy for a ventricular arrhythmia
  • Severe conduction disturbance
  • Angina pectoris requiring therapy
  • Uncontrolled hypertension per the Investigator's discretion
  • New York Heart Association Class II, III, or IV cardiovascular disease Active or chronically recurrent bleeding (eg, active peptic ulcer disease) 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 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

Sites / Locations

  • University of Maryland Medical Center - M & S Greenebaum Cancer Center
  • Sidney Kimmel Cancer Center Johns Hopkins Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Imetelstat (7.5 mg/kg)

Imetelstat (9.4 mg/kg)

Arm Description

Imetelstat (7.5 mg/kg) with or without lenalidomide standard of care

Imetelstat (9.4 mg/kg) with or without lenalidomide standard of care

Outcomes

Primary Outcome Measures

Rate of Improvement in Response
To determine the rate of improvement in response in patients with previously treated multiple myeloma following treatment with imetelstat alone or in combination wtih lenalidomide maintenance therapy. Response will be assessed using the International Uniform Response Criteria for Multiple Myeloma (IURCMM).

Secondary Outcome Measures

Progression-free Survival (PFS)
As assessed from Cycle 1 Day 1 to first evidence of PD as defined by IURCMM, or death, whichever occurs first.
Safety and Tolerability
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.

Full Information

First Posted
November 16, 2010
Last Updated
April 13, 2016
Sponsor
Geron Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT01242930
Brief Title
Open Label Study With Imetelstat to Determine Effect of Imetelstat in Patients w/ Previously Treated Multiple Myeloma
Official Title
A Phase II Trial to Determine the Effect of Imetelstat (GRN163L) on Patients With Previously Treated Multiple Myeloma
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
November 2014 (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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
imetelstat, imetelstat sodium, GRN163L, telomerase inhibitor, telomerase inhibition, multiple myeloma, myeloma, myeloma progenitor cells

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Imetelstat (7.5 mg/kg)
Arm Type
Experimental
Arm Description
Imetelstat (7.5 mg/kg) with or without lenalidomide standard of care
Arm Title
Imetelstat (9.4 mg/kg)
Arm Type
Experimental
Arm Description
Imetelstat (9.4 mg/kg) with or without lenalidomide standard of care
Intervention Type
Drug
Intervention Name(s)
Imetelstat (7.5 mg/kg)
Other Intervention Name(s)
GRN163L
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
lenalidomide standard of care
Other Intervention Name(s)
Revlimid
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Imetelstat (9.4 mg/kg)
Other Intervention Name(s)
GRN163L
Intervention Description
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.
Primary Outcome Measure Information:
Title
Rate of Improvement in Response
Description
To determine the rate of improvement in response in patients with previously treated multiple myeloma following treatment with imetelstat alone or in combination wtih lenalidomide maintenance therapy. Response will be assessed using the International Uniform Response Criteria for Multiple Myeloma (IURCMM).
Time Frame
From time of first dose (Cycle 1 day 1) through end of study period (12 mos. after last participant is enrolled)
Secondary Outcome Measure Information:
Title
Progression-free Survival (PFS)
Description
As assessed from Cycle 1 Day 1 to first evidence of PD as defined by IURCMM, or death, whichever occurs first.
Time Frame
From time of first dose (Cycle 1 day 1) through end of study (12 mos. after last participant is enrolled)
Title
Safety and Tolerability
Description
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.
Time Frame
From time of first dose (Cycle 1 day 1) through end of study (12 mos. after last participant is enrolled)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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): ANC ≥ 1000/μL Platelet count ≥ 50 x 103/μL (without transfusion support within 2 weeks prior to first study drug administration) Hemoglobin ≥ 8.0 g/dL Serum creatinine ≤ 3 x the upper limit of normal (ULN) AST (SGOT) and ALT (SGPT) ≤ 2.5 x the upper limit of normal (ULN), unless due to disease. 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: Congestive heart failure (CHF) requiring therapy Need for antiarrhythmic therapy for a ventricular arrhythmia Severe conduction disturbance Angina pectoris requiring therapy Uncontrolled hypertension per the Investigator's discretion New York Heart Association Class II, III, or IV cardiovascular disease Active or chronically recurrent bleeding (eg, active peptic ulcer disease) 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ted Shih, PharmD
Organizational Affiliation
Geron Corporation
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Carol Ann Huff, M.D.
Organizational Affiliation
Sidney Kimmel Cancer Center at Johns Hopkins Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Maryland Medical Center - M & S Greenebaum Cancer Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Sidney Kimmel Cancer Center Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21231
Country
United States

12. IPD Sharing Statement

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

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