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

Multiple Myeloma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00594126
• Other study ID #: CP14A004
• Status: Completed
• Phase: Phase 1
• First received: January 3, 2008
• Last updated: December 22, 2015
• Start date: November 2007
• Est. completion date: July 2011

Study information

• Verified date: December 2015
• Source: Geron Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Drug:
• Imetelstat Sodium (GRN163L)
25% dose escalation infused over 2 hours weekly

Locations

Country	Name	City	State
United States	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University	Baltimore	Maryland
United States	Dana Farber Cancer Institute	Boston	Massachusetts
United States	Roswell Park Cancer Institute	Buffalo	New York

Sponsors (1)

Lead Sponsor	Collaborator
Geron Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and MTD		First 3 weeks	Yes
Secondary	PK, PD, and efficacy		Baseline to end of treatment	No

External Links

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