WithdrawnPhase 1

A Study of Durvalumab (Anti-PDL1) Plus Radiation Therapy for the Treatment of Solitary Bone Plasmacytoma

Stopped: FDA recommendation

United States0Started 2017-07-27

Plain-language summary

This study is being done to evaluate whether the combination of immune therapy and radiation therapy to plasmacytoma that can stimulate the immune system to attack and eliminate the abnormal cells in the bone marrow and perhaps delay or prevent the cancer from worsening. This study will evaluate whether the immune system responds to the combination of radiation with immunotherapy. It is possible that that the combination of immune therapy and radiation may not make any difference in whether or not the patient will develop multiple myeloma in the future.

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: * Age ≥18 years * Histologically confirmed plasmacytoma amenable for biopsy * Detectable clonal bone marrow plasma cells by multicolor flow cytometry and less than 10% clonal plasma cells in a bone marrow biopsy by immunohistochemistry, morphology, or flow cytometry. * Clinically safe to delay radiation for at least 2 weeks. * ECOG performance status of 0-1. * Anticipated lifespan greater than 3 month. * Adequate organ function, as defined below: * Total bilirubin within normal ranges unless associated with hepatobiliary metastases or Gilbert syndrome, then total bilirubin ≤ 2 x ULN * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 x ULN * Creatinine ≤ 2.0 mg/dL * Able and willing to give valid written informed consent. Exclusion Criteria: * Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease \[eg, colitis, Crohn's disease\], diverticulitis with the exception of a prior episode that has resolved or diverticulosis, celiac disease, irritable bowel disease, or other serious gastrointestinal chronic conditions associated with diarrhea; systemic lupus erythematosus; Wegener's syndrome \[granulomatosis with polyangiitis\]; myasthenia gravis; Graves' disease; rheumatoid arthritis; hypophysitis, uveitis; etc) within the past 3 years prior to the start of treatment. The following are exceptions to this criterion: subjects with vitiligo or alopecia; subjects with hypothyroidism (eg…

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

Response assessment

Timeframe: up to 36 months from start of cycle 1

Trial details

NCT IDNCT03196401

SponsorMemorial Sloan Kettering Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-06

View on ClinicalTrials.gov More Solitary Bone Plasmacytoma trials