Multiple Myeloma Clinical Trial
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
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.
Status | Completed |
Enrollment | 20 |
Est. completion date | July 2011 |
Est. primary completion date | July 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | 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 |
Lead Sponsor | Collaborator |
---|---|
Geron Corporation |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety and MTD | First 3 weeks | Yes | |
Secondary | PK, PD, and efficacy | Baseline to end of treatment | No |
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