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

Completed · Phase 1

Conditions studied: Multiple Myeloma

In brief

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.

Key facts

Study ID

NCT00594126

Run by

Geron Corporation

People needed

20

Starts

2007-11-01

Expected to finish

2011-07-01

Last updated by the study team

2015-12-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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%

You may not qualify if…

• 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

Where it is running

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University — Baltimore, Maryland, United States
• Dana Farber Cancer Institute — Boston, Massachusetts, United States
• Roswell Park Cancer Institute — Buffalo, New York, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.