Pembrolizumab and Radiation Therapy in Patients With Relapsed or Refractory Multiple Myeloma (NCT03267888) | Clinical Trial Compass
CompletedPhase 1/2
Pembrolizumab and Radiation Therapy in Patients With Relapsed or Refractory Multiple Myeloma
United States25 participantsStarted 2018-05-29
Plain-language summary
This pilot clinical trial studies the side effects of pembrolizumab and radiation therapy in treating patients with stage I-III multiple myeloma that has come back after a period of improvement or that does not respond to treatment. Monoclonal antibodies, such as pembrolizumab, may block cancer growth in different ways by targeting certain cells. Radiation therapy uses high energy x-rays to kill cancer cells and shrink tumors. Giving pembrolizumab and radiation therapy may work better in treating patients with stage I-III multiple myeloma.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* International Staging System (ISS) stage I-III multiple myeloma that has progressive, relapsed, or refractory disease
* Able to give informed consent
* Eastern Cooperative Oncology Group (ECOG) 0-1
* Relapsed and/or refractory myeloma; there is no minimum or maximum number of previous therapies that a patient may have received previously before being put on the current trial
* ≥ 1 osseous and/or extra-osseous lesion that can be radiated
* Candidate for pembrolizumab (as determined by physician, and adequate organ function)
* Candidate for radiotherapy (as determined by treatment physician); these patients can have symptomatic disease and/or asymptomatic disease; a minimum of one site of radiation is required to any osseous and/or any extra-osseous disease; radiation to any bony parts of the head and neck, skull, spine, ribs, and/or extremities are allowed; radiation to any bony part for documented lytic disease is allowed; radiation to any soft tissue plasmacytoma (including osseous and extra-osseous plasmacytoma) is allowed; the only exclusion criteria for radiation, is central nervous system (CNS) metastases
* Measurable myeloma disease (urine protein \> 200 mg in 24 hours \[hr\] urine collection, serum free light chain ratio \> 100 with an abnormal k/l ratio, serum M protein \> 0.5 g/dl); 12 of the 24 patients do not have to have measurable disease
* Negative urine pregnancy test within 2 weeks for female subjects; female subjects of childbearing pot…