Solitary Bone PlasmacytomaPhase 1NCT03196401
A Study of Durvalumab (Anti-PDL1) Plus Radiation Therapy for the Treatment of Solitary Bone Plasmacytoma
A Phase 1 study testing Durvalumab and Radiation therapy in people with Solitary Bone Plasmacytoma, run by Memorial Sloan Kettering Cancer Center at 6 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solitary Bone Plasmacytoma
- What is being tested?
- Durvalumab and Radiation therapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 6 sitesUnited States
- Study dates
- 27 Jul 2017to Jun 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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, following Hashimoto syndrome) stable on hormone replacement; or subjects with psoriasis not requiring systemic treatment.
- Current or prior use of immunosuppressive medication within 14 days prior to first dose of durvalumab. The following are exceptions to this criterion: intranasal, inhaled, topical or local steroid injections (eg. intra-articular injection); steroids as premedication for hypersensitivity reactions; systemic corticosteroid at physiologic doses not to exceed 10mg/day of prednisone or equivalent.
- Known human immunodeficiency virus (HIV), hepatitis C virus (HCV) or evidence of active hepatitis B virus (HBV).
- History of hypersensitivity to durvalumab or any excipient
- History of hypersensitivity to the combination or comparator agent (If applicable) Receipt of live attenuated vaccination within 30 days prior the first dose of durvalumab.
- Female subjects who are pregnant, breast-feeding or female patients of reproductive potential who are not employing an effective method of birth control from starting dose of durvalumab (Cycle 1 Day 1), including dosing interruptions through 90 days after receipt of the last dose of durvalumab. Refrain from egg cell donation while taking durvalumab and for at least 90 days after the last dose of durvalumab.
- Male subjects who are not employing an effective method of birth control from starting dose of durvalumab (Cycle 1 Day 1), including dosing interruptions through 90 days after receipt of the last dose of durvalumab. Refrain from sperm donation while taking durvalumab and for at least 90 days after the last dose of durvalumab.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, 07920
Memorial Sloan Kettering Commack
Commack, New York, 11725
Memorial Sloan Kettering Westchester
Harrison, New York, 10604
Memoral Sloan Kettering Monmouth
Middletown, New Jersey, 07748
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Memorial Sloan Kettering Rockville Centre
Rockville Centre, New York, 11570
About this study
Official title: A Pilot Study to Evaluate for the Abscopal Effect of Durvalumab (Anti-PD-L1) in Combination With Definitive Radiation Therapy in Solitary Bone Plasmacytoma With Limited Clonal Bone Marrow Plasmacytosis
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.
- Conditions
- Solitary Bone Plasmacytoma
- Being tested
- Durvalumab, Radiation therapy
- Keywords
- Durvalumb, Radiation Therapy, Clonal Bone Marrow Plasmacytosis, MEDI4736, 17-269
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DurvalumabDrug
Also called (MEDI4736)
durvalumab 1500mg administered intravenously every 28 days, for a total of six doses
Radiation therapyRadiation
concurrent definitive radiation therapy to the bone plasmacytoma initiated within two weeks of starting
| Study group | Role | What they receive |
|---|---|---|
| Durvalumab Plus Radiation Therapy | Experimental | Durvalumab (1500mg administered intravenously every 28 days), concurrently with definitive radiation therapy to the solitary bone plasmacytoma to start within 14 days of the first dose of durvalumab. Receives: Drug: Durvalumab; Radiation: Radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response assessment
Disease assessments are made according to IMWG criteria including criteria for minimal residual disease
Measured: up to 36 months from start of cycle 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2017
- Study start27 Jul 2017
- Primary completionJun 2020 (estimated)
- Study completionJun 2020 (estimated)
Why it stopped: FDA recommendation
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solitary Bone PlasmacytomaStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is an open-label, single center, single-arm pilot study of checkpoint blockade therapy (anti-PD-L1) plus radiation.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Celgene Corporation
- Responsible party
- Sponsor
- Investigators
- Alexander Lesokhin, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03196401
- Sponsor's protocol ID
- 17-269
- Status last verified
- Aug 2018
- First submitted
- 21 Jun 2017
- Last updated
- 3 Aug 2018
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Evaluate for the Abscopal Effect of Durvalumab (Anti-PD-L1) in Combination With Definitive Radiation Therapy in Solitary Bone Plasmacytoma With Limited Clonal Bone Marrow Plasmacytosis
- ClinicalTrials.gov ID
- NCT03196401
- Acronym / sponsor ID
- 17-269
- Conditions
- Solitary Bone Plasmacytoma
- Keywords
- Durvalumb, Radiation Therapy, Clonal Bone Marrow Plasmacytosis, MEDI4736, 17-269
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: FDA recommendation
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- Celgene Corporation
- Study start
- 27 Jul 2017 (actual)
- Primary completion
- Jun 2020 (estimated)
- Study completion
- Jun 2020 (estimated)
- First posted
- 22 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is an open-label, single center, single-arm pilot study of checkpoint blockade therapy (anti-PD-L1) plus radiation.
| Arm | Type | Receives |
|---|---|---|
| Durvalumab Plus Radiation Therapy | Experimental | Drug: Durvalumab, Radiation: Radiation therapyDurvalumab (1500mg administered intravenously every 28 days), concurrently with definitive radiation therapy to the solitary bone plasmacytoma to start within 14 days of the first dose of durvalumab. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (7 listed)
- 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, following Hashimoto syndrome) stable on hormone replacement; or subjects with psoriasis not requiring systemic treatment.
- Current or prior use of immunosuppressive medication within 14 days prior to first dose of durvalumab. The following are exceptions to this criterion: intranasal, inhaled, topical or local steroid injections (eg. intra-articular injection); steroids as premedication for hypersensitivity reactions; systemic corticosteroid at physiologic doses not to exceed 10mg/day of prednisone or equivalent.
- Known human immunodeficiency virus (HIV), hepatitis C virus (HCV) or evidence of active hepatitis B virus (HBV).
- History of hypersensitivity to durvalumab or any excipient
- History of hypersensitivity to the combination or comparator agent (If applicable) Receipt of live attenuated vaccination within 30 days prior the first dose of durvalumab.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DurvalumabAlso: (MEDI4736)durvalumab 1500mg administered intravenously every 28 days, for a total of six doses | Drug | Durvalumab Plus Radiation Therapy |
| Radiation therapyconcurrent definitive radiation therapy to the bone plasmacytoma initiated within two weeks of starting | Radiation | Durvalumab Plus Radiation Therapy |
Primary outcome
Response assessment
Time frame: up to 36 months from start of cycle 1
Disease assessments are made according to IMWG criteria including criteria for minimal residual disease
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2018.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexander Lesokhin, MD principal investigator
Memorial Sloan Kettering Cancer Center
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Durvalumab and Radiation therapy in people with Solitary Bone Plasmacytoma, run by Memorial Sloan Kettering Cancer Center at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 3 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response assessment (time frame: up to 36 months from start of cycle 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2018.