Clinical Trial: Safety and Tolerability Study of SNS01-T in Relapsed or Refractory B Cell Malignancies (Multiple Myeloma, B Cell Lymphoma, or Plasma Cell Leukemia (PCL)
Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional
Official Title: Phase 1/2 Open-Label, Multiple-Dose, Dose-Escalation Study to Evaluate the Safety and Tolerability of SNS01-T Administered by Intravenous Infusion in Patients With Relapsed or Refractory B Cell Malign
Brief Summary: The purpose of this study is to determine how well SNS01-T is tolerated by relapsed or refractory multiple myeloma, B cell lymphoma or plasma cell leukemia patients when given by intravenous infusion at various doses.
Detailed Summary: The main purpose is to test the safety and tolerability of SNS01-T. The first group of patients with relapsed or refractory multiple myeloma, plasma cell leukemia or B cell lymphoma will be given a relatively low dose. If tolerated, a second group will receive a higher dose. If tolerated by the second group, a third and then a fourth group will receive higher doses. Treatment-related adverse events (side effects), changes in vital signs, physical examination, and laboratory values will be monitored. Patients will receive twice weekly infusions for 6 weeks and then will be followed monthly for 6 months. A secondary purpose is to explore whether SNS01-T is an effective treatment for multiple myeloma, B cell lymphoma and plasma cell leukemia.
Sponsor: Senesco Technologies, Inc.
Current Primary Outcome: Safety and tolerability [ Time Frame: Week 6 ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Profile of pharmacokinetics [ Time Frame: 0.5 hours pre-dose and 0.5, 2, 6 and 24 hours post-dose ]Cmax, area under curve, Tmax. Performed on Weeks 1, 3, 6, 10, 14, 18
- Explore tumor response [ Time Frame: Weeks 3 and 6, and monthly during a 24-week follow-up period ]IMWG criteria, changes in M-protein, etc. for myeloma and plasma cell leukemia; Lymphoma response criteria, CT/PET scans for B cell lymphoma
Original Secondary Outcome:
- Profile of pharmacokinetics [ Time Frame: 0.5 hours pre-dose and 0.5, 2, 6 and 24 hours post-dose ]Cmax, area under curve, Tmax. Performed on Weeks 1, 3, 6, 10, 14, 18
- Explore tumor response [ Time Frame: Weeks 3 and 6, and monthly during a 24-week follow-up period ]IMWG criteria; changes in M-protein, etc
Information By: Senesco Technologies, Inc.
Dates:
Date Received: September 14, 2011
Date Started: September 2011
Date Completion: December 2014
Last Updated: September 9, 2014
Last Verified: September 2014