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

Sponsor

Geron Corporation (Industry)

Overall Status

Completed

CT.gov ID

NCT00718601

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

13.3

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Multiple Myeloma	Drug: Imetelstat Sodium (GRN163L)	Phase 1

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 Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Official Title:

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

Study Start Date :

Jul 1, 2008

Actual Primary Completion Date :

Oct 1, 2011

Actual Study Completion Date :

Oct 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 3+3 cohort dose escalation	Drug: Imetelstat Sodium (GRN163L) 25% dose escalation infused over 2 hours weekly

Arm

Intervention/Treatment

Experimental: 1

3+3 cohort dose escalation

Drug: Imetelstat Sodium (GRN163L)

25% dose escalation infused over 2 hours weekly

Outcome Measures

Primary Outcome Measures

Maximum tolerated dose [First 3 weeks]

Secondary Outcome Measures

Safety, PK and efficacy [Baseline to 28 days after last dose of treatment]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Karmanos Cancer Center	Detroit	Michigan	United States	48201
2	St. Vincent's Comprehensive Cancer Center	New York City	New York	United States	10011
3	Fred Hutchinson Cancer Research Center	Seattle	Washington	United States	98109