Pembrolizumab in Treating Patients With Intermediate or High-Risk Smoldering Multiple Myeloma (NCT02603887) | Clinical Trial Compass
Active — Not RecruitingEarly Phase 1
Pembrolizumab in Treating Patients With Intermediate or High-Risk Smoldering Multiple Myeloma
United States20 participantsStarted 2016-07-20
Plain-language summary
This pilot early phase I trial studies pembrolizumab in treating patients with slow growing (smoldering) multiple myeloma with intermediate or high-risk of spreading. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
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:
* Adult patients with intermediate or high-risk smoldering multiple myeloma (SMM) are eligible; patients need to have clonal bone marrow plasma cells \>= 10% and/or monoclonal spike in blood of \>= 3 g/dL and/or monoclonal urine component (Bence jones proteinuria) \>= 500 mg/24 hours and need to meet subject inclusion criteria and exclusion criteria as per below
* Patients must have histologically confirmed SMM based on the following criteria:
* (A) Mayo clinic criteria (patient must have at least 2 risk factors present):
* 1\. Bone marrow core biopsy plasma cell involvement by cluster of differentiation (CD)138 immunohistochemistry \>= 10%
* 2\. Monoclonal spike \>= 3 g/dL
* 3\. Free light chain ratio in serum \< 0.125 or \> 8; \*2 of 3 risk factors: intermediate risk for progression at a rate of 51% at 5 years, \*3 of 3 risk factors: high risk for progression at a rate of 76% at 5 years
* OR (B) Programa para el Tratamiento de Hemopatias Malignas (PETHEMA) criteria (patient must have at least 1 risk factor present)
* 1\. \>= 95% abnormal plasma cells/total plasma cells in bone marrow compartment
* 2\. Immunoparesis \*1 of 2 risk factors: intermediate risk for progression at a rate of 46% at 5 years, \*2 of 2 risk factors: high risk for progression at a rate of 72% at 5 years
* OR (C) Southwestern Oncology Group (SWOG) criteria (patient must have 2 risk factors present or one risk factor if this risk factor is a 70-gene signa…
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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.
What they're measuring
1
Overall Response Rate (ORR)
Timeframe: From cycle 1 to cycle 8, up to 168 days