Safety and Tolerability Study of SNS01-T in Relapsed or Refractory B Cell Malignancies (Multiple … (NCT01435720) | Clinical Trial Compass
UnknownPhase 1/2
Safety and Tolerability Study of SNS01-T in Relapsed or Refractory B Cell Malignancies (Multiple Myeloma, B Cell Lymphoma, or Plasma Cell Leukemia (PCL)
United States, South Africa15 participantsStarted 2011-09
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. B cell lymphoma patients must have had their diagnosis confirmed histologically. Plasma cell leukemia (PCL) patients must have peripheral clonal plasma cells \>20% of peripheral WBC and \>2 x 109/L. Multiple myeloma and PCL patients must have been diagnosed by having met all three of the following IMWG criteria:
. B cell lymphoma patients must have measurable disease defined as at least one lesion that can be accurately measured for response in at least two perpendicular dimensions. Multiple myeloma patients must have measurable disease defined by the following:
. Have relapsed or refractory disease after two or more prior treatment lines, each of which may have consisted of either single or multiple regimens. The investigators will ensure that patients have had the benefit of standard treatments before considering the SNS01-T clinical trial.
. Be at least 2 weeks beyond the last therapy and have recovered from acute toxicities of prior therapies
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this is a Phase 1/2 trial primarily measuring safety and tolerability of SNS01-T, what does that mean for how much we currently know about whether it actually works against my specific condition — multiple myeloma, B cell lymphoma, or plasma cell leukemia?
2The recruitment status for this trial is listed as unknown — can you find out whether this study is still actively enrolling patients, or whether it has closed, before we spend time considering it?
3Given that this trial is for people whose disease has relapsed or stopped responding to prior treatments, how does SNS01-T compare to other options I might still have available, like standard salvage therapies or other clinical trials?
4Since SNS01-T appears to be a newer agent being tested for the first time in this combination of B cell malignancies, what are the potential risks I should be aware of going into a Phase 1 study where the safety profile is still being established?
5If I were to enroll in this trial, what would the treatment schedule and monitoring requirements look like in practice — and is that something that would realistically fit with my current health situation and daily life?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Have Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
. Have life expectancy of at least 3 months
. Be ≥18 years of age and willing to provide written informed consent
. For women and men of childbearing potential, have used effective contraceptive methods for at least 4 weeks prior to dosing and agree to continue using such methods during the study, and for at least 4 weeks after completing the study
Exclusion criteria
. Have presence of nonsecretory myeloma
. Have an indolent lymphoma such as follicular lymphoma unless the disease is rapidly progressing
. Requires renal dialysis
. Have New York Heart Association Class III-IV heart failure classification
. Have CNS or leptomeningeal disease
. Have an active infection or serious comorbid medical condition
. Be receiving other concurrent anticancer agents or therapies
. Be receiving other concurrent investigational therapies or have received investigational therapies within 4 weeks of screening or 5 half-lives, if known, whichever is shorter