Clinical trial NCT00718601: Safety and Dose Study of GRN163L and Velcade to Treat Patients With Refractory or Relapsed Myeloma
Official title: A Phase I Study of GRN163L in Combination With Bortezomib and Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Multiple Myeloma
Keywords: Myeloma
Multiple Myeloma
Relapsed Multiple Myeloma
Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma
Lead sponsor: Geron Corporation
Sponsor class: INDUSTRY
First posted: 2008-07-18
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: 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.

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 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

Primary outcomes:
measure: Maximum tolerated dose
timeFrame: First 3 weeks
Secondary outcomes:
measure: Safety, PK and efficacy
timeFrame: Baseline to 28 days after last dose of treatment
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Karmanos Cancer Center
state: Michigan
city: New York City
country: United States
facility: St. Vincent's Comprehensive Cancer Center
state: New York
city: Seattle
country: United States
facility: Fred Hutchinson Cancer Research Center
state: Washington
Study officials:
affiliation: Geron Corporation
name: Stephen Kelsey, MD
role: STUDY_DIRECTOR
References: