Safety and Dose Study of GRN163L and Velcade to Treat Patients With Refractory or Relapsed Myeloma

This study has been completed.

Sponsor:

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

History of Changes

Tracking Information

First Received Date ^ICMJE

July 16, 2008

Last Updated Date

January 24, 2012

Start Date ^ICMJE

July 2008

Primary Completion Date

October 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Maximum tolerated dose [ Time Frame: First 3 weeks ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00718601 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Safety, PK and efficacy [ Time Frame: Baseline to 28 days after last dose of treatment ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Safety and Dose Study of GRN163L and Velcade to Treat Patients With Refractory or Relapsed Myeloma

Official Title ^ICMJE

A Phase I Study of GRN163L in Combination With Bortezomib and Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma

Brief Summary

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.

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label

Condition ^ICMJE

Multiple Myeloma

Intervention ^ICMJE

Drug: Imetelstat Sodium (GRN163L)

25% dose escalation infused over 2 hours weekly

Study Arm (s)

Experimental: 1

3+3 cohort dose escalation

Intervention: Drug: Imetelstat Sodium (GRN163L)

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Completion Date

October 2011

Primary Completion Date

October 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00718601

Other Study ID Numbers ^ICMJE

GRN163L CP14A011

Has Data Monitoring Committee

Responsible Party

Geron Corporation

Study Sponsor ^ICMJE

Geron Corporation

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Stephen Kelsey, MD

Geron Corporation

Information Provided By

Geron Corporation

Verification Date

January 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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