PlasmacytomaPhase 2NCT04174196
A Study of Lenalidomide and CC-486 With Radiation Therapy in Patients With Plasmacytoma
A Phase 2 study testing CC-486, Lenalidomide and Radiation Therapy in people with Plasmacytoma and Plasmacytoma of Bone, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.
Trial summary
The purpose of this study is to investigate if the combination of CC-486 with lenalidomide and radiation therapy is a safe and effective treatment for plasmacytoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Plasmacytoma, Plasmacytoma of Bone, Multiple Myeloma
- What is being tested?
- CC-486, Lenalidomide and Radiation Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 7 sitesUnited States
- Study dates
- 19 Nov 2019to 19 Nov 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- Cohort 1: Must meet all the following 3 criteria:
- Histologically confirmed newly diagnosed or recurrent solitary plasmacytoma/lytic lesion (recurrent solitary plasmacytomas will be considered based on treating physician discretion for cases where they clinically plan to treat with RT alone) - Minimal marrow involvement (Detectable clonal bone marrow plasma cells by multicolor flow cytometry and </= 10% clonal plasma cells in a bone marrow biopsy by immunohistochemistry, morphology, or flow cytometry)
- Secretory M protein < 3 g/dL
- Cohort 2: Must meet all the following criteria:
- Relapsed multiple myeloma with plasmacytomas/lytic lesion appropriate for RT on imaging
- Relapsed (reappearance of M-spike/serum FLC) or progressive myeloma defined by a 25% increase from nadir in M-spike or involved serum FLB on 2 separate measurements; or with bone marrow involvement by clonal plasma cells detectable by IHC or flow cytometry.
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- Any prior number of therapies is permitted, including prior radiation therapy
- Allogeneic transplant patients are permitted
- All Cohorts:
- Age >/= 18 years
- Surgical resection of plasmacytoma or stabilization surgery is permitted if necessary based on physician judgement
- ECOG performance status of 0-1
- Anticipated lifespan greater than 3 months
- Able and willing to give valid written informed consent
- Creatinine clearance >/=30ml/min by Cockroft-Gault method. See section below, "Dosing Regimen", regarding lenalidomide dose adjustment for calculated creatinine clearance >/= 30ml/min and <60ml/min
- Serum bilirubin levels </= 1.5 times the upper limit of the normal range for the laboratory (ULN). Higher levels are acceptable if these can be attributed to active hemolysis or ineffective erythropoiesis of Gilbert's syndrome
- AST (SGOT) and ALT (SGPT) </= 2.5 x ULN
- Women of childbearing potential should be advised to avoid becoming pregnant and must adhere to the scheduled pregnancy testing a required in the Revlimid REMS program. They must be agreeable to use acceptable methods of birth control throughout the study and for at least 6 months after the last dose:
- Recommendation is for 2 effective contraceptive methods during the study and for at least 6 months after the last dose. Adequate forms of contraception are double-barrier methods (condoms with spermicidal jelly or foam and diaphragm with spermicidal jelly or foam), oral, depo provera, or injectable contraceptive, intrauterine devices, and tubal ligation.
- Agree to abstain from breastfeeding during study participation and for at least 90 days after the last dose of investigational product (IP). Men should be advised to not father a child while receiving treatment with azacitidine. Male patients with female partners who are of childbearing potential: Recommendation is for the patient and partner use at least 2 effective contraceptive methods, as described above, during the study and for 3 months following the last dose of study drug.
- Refrain from semen or sperm donation while taking IP and for at least 90 days after the last dose of IP.
- Willing to be registered into the mandatory Revlimid REMS program, and be willing and able to comply with the requirements of the REMS program.
- Able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation (patients intolerant to ASA may use physician's choice of anticoagulation).
- Able to swallow oral medication
- Hematologic criteria: Hemoglobin >/= 9 g/dL, platelets >/= 50,000 and ANC >/= 1
Who cannot join
- Subjects should not enter the study if any of the following exclusion criteria are fulfilled:
- Pregnant or breast feeding females. (Lactating females must agree not to breast feed while taking azacitidine).
- Uncontrolled systemic fungal, bacterial or viral infection (defined as ongoing signs/symptoms related the infection without improvement despite appropriate antibiotics, antiviral therapy and/or other treatment)
- History of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis), celiac disease (ie, sprue), prior gastrectomy or upper bowel removal, or any other gastrointestinal disorder or defect that would interfere with the absorption, distribution, metabolism or excretion of the study drug and/or predispose the subject to an increased risk of gastrointestinal toxicity
- Abnormal coagulation parameters without any known etiology (PTT > 45 seconds, and/or INR > 1.5). Patients currently on therapeutic anti-coagulation treatment are exempt from these parameters.
- Significant active cardiac disease within the previous 6 months including:
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- NYHA class 4 CHF Unstable angina Myocardial infarction
- known or suspected hypersensitivity to azacitidine or mannitol
- Known hypersensitivity to thalidomide or lenalidomide
- The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs
- Active viral infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV) as determined by a positive Polymerase Chain Reaction (PCR) will be excluded. Patients who are seropositive because of HBV vaccine are eligible. Seropositive status-antibody positive patients with negative PCR on two occasions will be eligible
- Concurrent systemic chemotherapy with drugs other than CC-486 and lenalidomide.
- Patients on tacrolimus therapy
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, 07920
Memorial Sloan Kettering Cancer Center @ Commack
Commack, New York, 11725
Memorial Sloan Kettering Westchester
Harrison, New York, 10604
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, 07748
Memorial Sloan Kettering Bergen
Montvale, New Jersey, 07645
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Memorial Sloan Kettering Nassau
Uniondale, New York, 11553
About this study
Official title: A Pilot Study Evaluating Lenalidomide and CC-486 in Combination With Radiotherapy For Patients With Plasmacytoma (LENAZART Study)
The purpose of this study is to investigate if the combination of CC-486 with lenalidomide and radiation therapy is a safe and effective treatment for plasmacytoma.
- Conditions
- Plasmacytoma, Plasmacytoma of Bone, Multiple Myeloma
- Being tested
- CC-486, Lenalidomide, Radiation Therapy
- Keywords
- CC-486, Plasmacytoma, lenalidomide, Plasmacytoma of Bone, Memorial Sloan Kettering Cancer Center, 19-284, multiple myeloma with plasmacytomas, multiple myeloma
- Medical subject headings
- Plasmacytoma, Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CC-486Drug
Participants will be treated with CC-486 and lenalidomide for 6 cycles
LenalidomideDrug
Participants will be treated with CC-486 and lenalidomide for 6 cycles
Radiation TherapyRadiation
Radiation therapy will be initiated to the plasmacytoma after cycle 2
| Study group | Role | What they receive |
|---|---|---|
| Participants with Plasmacytoma | Experimental | Participants will have solitary bone plasmacytoma with minimal marrow involvement and participants with relapsed multiple myeloma with plasmacytomas Receives: Drug: CC-486; Drug: Lenalidomide; Radiation: Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure Complete Response
Stringent complete response (sCR) will be computed by 2016 IMWG Criteria in addition to identifying no new lesions on PET at the end of 6 cycles of therapy
Measured: At the end of Cycle 6 (each cycle is 28 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2019
- Study start19 Nov 2019
- Primary completion19 Nov 2026 (estimated)
- Study completion19 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Urvi Shah, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04174196
- Sponsor's protocol ID
- 19-284
- Status last verified
- Dec 2025
- First submitted
- 20 Nov 2019
- Last updated
- 2 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study Evaluating Lenalidomide and CC-486 in Combination With Radiotherapy For Patients With Plasmacytoma (LENAZART Study)
- ClinicalTrials.gov ID
- NCT04174196
- Acronym / sponsor ID
- 19-284
- Conditions
- Plasmacytoma, Plasmacytoma of Bone, Multiple Myeloma
- Keywords
- CC-486, Plasmacytoma, lenalidomide, Plasmacytoma of Bone, Memorial Sloan Kettering Cancer Center, 19-284, multiple myeloma with plasmacytomas, multiple myeloma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 19 Nov 2019 (actual)
- Primary completion
- 19 Nov 2026 (estimated)
- Study completion
- 19 Nov 2026 (estimated)
- First posted
- 22 Nov 2019 (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.
The purpose of this study is to investigate if the combination of CC-486 with lenalidomide and radiation therapy is a safe and effective treatment for plasmacytoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with Plasmacytoma | Experimental | Drug: CC-486, Drug: Lenalidomide, Radiation: Radiation TherapyParticipants will have solitary bone plasmacytoma with minimal marrow involvement and participants with relapsed multiple myeloma with plasmacytomas |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- Histologically confirmed newly diagnosed or recurrent solitary plasmacytoma/lytic lesion (recurrent solitary plasmacytomas will be considered based on treating physician discretion for cases where they clinically plan to treat with RT alone) - Minimal marrow involvement (Detectable clonal bone marrow plasma cells by multicolor flow cytometry and </= 10% clonal plasma cells in a bone marrow biopsy by immunohistochemistry, morphology, or flow cytometry)
- Secretory M protein < 3 g/dL
- Relapsed multiple myeloma with plasmacytomas/lytic lesion appropriate for RT on imaging
- Relapsed (reappearance of M-spike/serum FLC) or progressive myeloma defined by a 25% increase from nadir in M-spike or involved serum FLB on 2 separate measurements; or with bone marrow involvement by clonal plasma cells detectable by IHC or flow cytometry.
- Any prior number of therapies is permitted, including prior radiation therapy
Key exclusion criteria (13 listed)
- Subjects should not enter the study if any of the following exclusion criteria are fulfilled:
- Pregnant or breast feeding females. (Lactating females must agree not to breast feed while taking azacitidine).
- Uncontrolled systemic fungal, bacterial or viral infection (defined as ongoing signs/symptoms related the infection without improvement despite appropriate antibiotics, antiviral therapy and/or other treatment)
- History of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis), celiac disease (ie, sprue), prior gastrectomy or upper bowel removal, or any other gastrointestinal disorder or defect that would interfere with the absorption, distribution, metabolism or excretion of the study drug and/or predispose the subject to an increased risk of gastrointestinal toxicity
- Abnormal coagulation parameters without any known etiology (PTT > 45 seconds, and/or INR > 1.5). Patients currently on therapeutic anti-coagulation treatment are exempt from these parameters.
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 |
|---|---|---|
| CC-486Participants will be treated with CC-486 and lenalidomide for 6 cycles | Drug | Participants with Plasmacytoma |
| LenalidomideParticipants will be treated with CC-486 and lenalidomide for 6 cycles | Drug | Participants with Plasmacytoma |
| Radiation TherapyRadiation therapy will be initiated to the plasmacytoma after cycle 2 | Radiation | Participants with Plasmacytoma |
Primary outcome
Measure Complete Response
Time frame: At the end of Cycle 6 (each cycle is 28 days)
Stringent complete response (sCR) will be computed by 2016 IMWG Criteria in addition to identifying no new lesions on PET at the end of 6 cycles of therapy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2025.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
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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.
Urvi Shah, MD principal investigator
Memorial Sloan Kettering Cancer Center
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CC-486, Lenalidomide and Radiation Therapy in people with Plasmacytoma and Plasmacytoma of Bone, run by Memorial Sloan Kettering Cancer Center at 7 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 25 inclusion and 13 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: under way, not looking for participants, as of the sponsor's last update on 2 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Measure Complete Response (time frame: At the end of Cycle 6 (each cycle is 28 days)). 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 2 Dec 2025.