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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00718601
Recruitment Status : Completed
First Posted : July 18, 2008
Last Update Posted : December 24, 2015
Information provided by (Responsible Party):
Geron Corporation

July 16, 2008
July 18, 2008
December 24, 2015
July 2008
October 2011   (Final data collection date for primary outcome measure)
Maximum tolerated dose [ Time Frame: First 3 weeks ]
Same as current
Complete list of historical versions of study NCT00718601 on Archive Site
Safety, PK and efficacy [ Time Frame: Baseline to 28 days after last dose of treatment ]
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.
Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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 Identifier (NCT Number) in Medline.
Same as current
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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
GRN163L CP14A011
Not Provided
Not Provided
Geron Corporation
Geron Corporation
Not Provided
Study Director: Stephen Kelsey, MD Geron Corporation
Geron Corporation
December 2015

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