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Safety and Dose Study of GRN163L and Velcade to Treat Patients With Refractory or Relapsed Myeloma
This study is currently recruiting participants.
Verified by Geron Corporation, January 2009
Sponsored by: Geron Corporation
Information provided by: Geron Corporation
ClinicalTrials.gov Identifier: NCT00718601
  Purpose

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 Intervention Phase
Multiple Myeloma
Drug: GRN163L
Phase I

Genetics Home Reference related topics: aceruloplasminemia hemophilia
MedlinePlus related topics: Cancer Multiple Myeloma
Drug Information available for: Dexamethasone Dexamethasone acetate Dexamethasone Sodium Phosphate Doxiproct plus Bortezomib
U.S. FDA Resources
Study Type: Interventional
Study Design: Non-Randomized, Open Label, Single Group Assignment, Safety Study
Official Title: A Phase I Study of GRN163L in Combination With Bortezomib and Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma

Further study details as provided by Geron Corporation:

Primary Outcome Measures:
  • Maximum tolerated dose [ Time Frame: First 3 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Safety, PK and efficacy [ Time Frame: Baseline to 28 days after last dose of treatment ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 40
Study Start Date: July 2008
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
3+3 cohort dose escalation
Drug: 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
  • 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00718601

Contacts
Contact: Cheryl Schwab 650-566-7137 cschwab@geron.com
Contact: Catherine Howard 650-566-7221 choward@geron.com

Locations
United States, New Jersey
Hackensack University Medical Center Not yet recruiting
Hackensack, New Jersey, United States, 07601
Principal Investigator: David Seigel, md            
United States, New York
St. Vincent's Comprehensive Cancer Center Recruiting
New York, New York, United States, 10011
Principal Investigator: Sundar Jagganath, MD            
United States, Texas
University of Texas Health Science Center Not yet recruiting
San Antonio, Texas, United States, 78229
Principal Investigator: Swaminathan Padmanabhan            
United States, Washington
Fred Hutchinson Cancer Research Center Recruiting
Seattle, Washington, United States, 98109
Principal Investigator: William Bensinger, MD            
Sponsors and Collaborators
Geron Corporation
Investigators
Study Chair: Laurence Elias, MD Geron Corporation
  More Information

Related Info  This link exits the ClinicalTrials.gov site

Responsible Party: Geron Corporation ( Laurence Elias, MD )
Study ID Numbers: GRN163L CP14A011
Study First Received: July 16, 2008
Last Updated: January 8, 2009
ClinicalTrials.gov Identifier: NCT00718601  
Health Authority: United States: Food and Drug Administration

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

Study placed in the following topic categories:
Dexamethasone
Immunoproliferative Disorders
Blood Protein Disorders
Hematologic Diseases
Blood Coagulation Disorders
Bortezomib
Vascular Diseases
Paraproteinemias
Hemostatic Disorders
Multiple Myeloma
Hemorrhagic Disorders
Multiple myeloma
Lymphoproliferative Disorders
Dexamethasone acetate
Neoplasms, Plasma Cell

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Immune System Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 13, 2009