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A Phase I Study of GRN163L in Combination With Bortezomib and Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma


Phase 1
18 Years
N/A
Not Enrolling
Both
Multiple Myeloma

Thank you

Trial Information

A Phase I Study of GRN163L in Combination With Bortezomib and Dexamethasone in Patients With Relapsed or Refractory 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.


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label

Outcome Measure:

Maximum tolerated dose

Outcome Time Frame:

First 3 weeks

Safety Issue:

Yes

Principal Investigator

Stephen Kelsey, MD

Investigator Role:

Study Director

Investigator Affiliation:

Geron Corporation

Authority:

United States: Food and Drug Administration

Study ID:

GRN163L CP14A011

NCT ID:

NCT00718601

Start Date:

July 2008

Completion Date:

October 2011

Related Keywords:

  • Multiple Myeloma
  • Myeloma
  • Multiple Myeloma
  • Relapsed Multiple Myeloma
  • Refractory Multiple Myeloma
  • Relapsed or Refractory Multiple Myeloma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Name

Location

Fred Hutchinson Cancer Research CenterSeattle, Washington  98109
St. Vincent's Comprehensive Cancer CenterNew York, New York  10011
Karmanos Cancer CenterDetroit, Michigan  48201