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

July 16, 2008
January 24, 2012
July 2008
October 2011   (final data collection date for primary outcome measure)
Maximum tolerated dose [ Time Frame: First 3 weeks ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00718601 on ClinicalTrials.gov Archive Site
Safety, PK and efficacy [ Time Frame: Baseline to 28 days after last dose of treatment ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Safety and Dose Study of GRN163L and Velcade to Treat Patients With Refractory or Relapsed Myeloma
A Phase I Study of GRN163L in Combination With Bortezomib and Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma

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.

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.

Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Multiple Myeloma
Drug: Imetelstat Sodium (GRN163L)
25% dose escalation infused over 2 hours weekly
Experimental: 1
3+3 cohort dose escalation
Intervention: Drug: Imetelstat Sodium (GRN163L)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
October 2011
October 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00718601
GRN163L CP14A011
No
Geron Corporation
Geron Corporation
Not Provided
Study Director: Stephen Kelsey, MD Geron Corporation
Geron Corporation
January 2011

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