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

Multiple Myeloma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00718601
• Other study ID #: GRN163L CP14A011
• Status: Completed
• Phase: Phase 1
• First received: July 16, 2008
• Last updated: December 22, 2015
• Start date: July 2008
• Est. completion date: October 2011

Study information

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

Clinical Trial 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.

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: 40
• Est. completion date: October 2011
• Est. primary completion date: October 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

• 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

Study Design

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

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	Karmanos Cancer Center	Detroit	Michigan
United States	St. Vincent's Comprehensive Cancer Center	New York City	New York
United States	Fred Hutchinson Cancer Research Center	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Geron Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum tolerated dose		First 3 weeks	Yes
Secondary	Safety, PK and efficacy		Baseline to 28 days after last dose of treatment	Yes

External Links

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