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

NCT ID: NCT00718601

Last Updated: 2015-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2011-10-31

Brief Summary

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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

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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.

Conditions

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Multiple Myeloma

Keywords

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Myeloma Multiple Myeloma Relapsed Multiple Myeloma Refractory Multiple Myeloma Relapsed or Refractory Multiple Myeloma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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1

3+3 cohort dose escalation

Group Type EXPERIMENTAL

Imetelstat Sodium (GRN163L)

Intervention Type DRUG

25% dose escalation infused over 2 hours weekly

Interventions

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Imetelstat Sodium (GRN163L)

25% dose escalation infused over 2 hours weekly

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Geron Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Stephen Kelsey, MD

Role: STUDY_DIRECTOR

Geron Corporation

Locations

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Karmanos Cancer Center

Detroit, Michigan, United States

Site Status

St. Vincent's Comprehensive Cancer Center

New York, New York, United States

Site Status

Fred Hutchinson Cancer Research Center

Seattle, Washington, United States

Site Status

Countries

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United States

Related Links

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http://www.geron.com

Related Info

Other Identifiers

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GRN163L CP14A011

Identifier Type: -

Identifier Source: org_study_id