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
  Purpose

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.


Condition Intervention Phase
Multiple Myeloma
Drug: Imetelstat Sodium (GRN163L)
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Geron Corporation:

Primary Outcome Measures:
  • Safety and MTD [ Time Frame: First 3 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • PK, PD, and efficacy [ Time Frame: Baseline to end of treatment ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: November 2007
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1
3+3 cohort dose escalation
Drug: Imetelstat Sodium (GRN163L)
25% dose escalation infused over 2 hours weekly

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00594126

Locations
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University
Baltimore, Maryland, United States, 21231
United States, Massachusetts
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Sponsors and Collaborators
Geron Corporation
Investigators
Study Director: Steve Kelsey, MD Geron Corporation
  More Information

Additional Information:
No publications provided

Responsible Party: Geron Corporation
ClinicalTrials.gov Identifier: NCT00594126     History of Changes
Other Study ID Numbers: CP14A004
Study First Received: January 3, 2008
Last Updated: January 24, 2012
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Geron Corporation:
Myeloma
Multiple Myeloma
Relapsed Multiple Myeloma
Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on July 23, 2014