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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)

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

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

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

Arm Description

3+3 cohort dose escalation

Outcomes

Primary Outcome Measures

Safety and MTD

Secondary Outcome Measures

PK, PD, and efficacy

Full Information

NCT ID

NCT00594126

First Posted

January 3, 2008

Last Updated

December 22, 2015

Sponsor

Geron Corporation

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

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

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

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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