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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Geron Corporation
ClinicalTrials.gov Identifier:
NCT00594126
First received: January 3, 2008
Last updated: January 24, 2012
Last verified: January 2012

January 3, 2008
January 24, 2012
November 2007
July 2011   (final data collection date for primary outcome measure)
Safety and MTD [ Time Frame: First 3 weeks ] [ Designated as safety issue: Yes ]
  • Tolerability of each dose administration [ Time Frame: First 3 weeks ] [ Designated as safety issue: Yes ]
  • Maximum tolerated dose will be determined by the observed occurrence of dose limiting toxicities [ Time Frame: First 3 weeks ] [ Designated as safety issue: Yes ]
  • The safety of GRN163L will be evaluated by PE, lab toxicity, and the incidence and severity of AEs. [ Time Frame: Baseline to 28 days after the last dose of treatment ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00594126 on ClinicalTrials.gov Archive Site
PK, PD, and efficacy [ Time Frame: Baseline to end of treatment ] [ Designated as safety issue: No ]
  • Pharmacokinetics will be determined by serial measurements of its concentration in plasma [ Time Frame: Baseline to end of treatment ] [ Designated as safety issue: No ]
  • Efficacy will be determined by evidence of OR, DOR from the first recorded achievement of the response and TTP from the start of treatment. [ Time Frame: Start of treatment to time to progression ] [ Designated as safety issue: No ]
  • Pharmacodynamic markers from blood and bone marrow will be determined by inhibition of telomerase activity, markers of apoptosis, changes in normal and neoplastic cell telomere length and effects upon myeloma stem cell subpopulations. [ Time Frame: Baseline to end of treatment ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Safety and Dose Study of GRN163L Administered to Treat Patients With Refractory or Relapsed Multiple Myeloma
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

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.

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
Primary Purpose: Treatment
Multiple Myeloma
Drug: Imetelstat Sodium (GRN163L)
25% dose escalation infused over 2 hours weekly
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
20
July 2011
July 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
  • 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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00594126
CP14A004
No
Geron Corporation
Geron Corporation
Not Provided
Study Director: Steve Kelsey, MD Geron Corporation
Geron Corporation
January 2012

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