A Study of Lenalidomide and CC-486 With Radiation Therapy in Patients With Plasmacytoma
A Pilot Study Evaluating Lenalidomide and CC-486 in Combination With Radiotherapy For Patients With Plasmacytoma (LENAZART Study)
1 other identifier
interventional
21
1 country
7
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Nov 2019
Longer than P75 for phase_2
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 19, 2019
CompletedFirst Submitted
Initial submission to the registry
November 20, 2019
CompletedFirst Posted
Study publicly available on registry
November 22, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 19, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 19, 2026
December 2, 2025
December 1, 2025
7 years
November 20, 2019
December 1, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
At the end of Cycle 6 (each cycle is 28 days)
Study Arms (1)
Participants with Plasmacytoma
EXPERIMENTALParticipants will have solitary bone plasmacytoma with minimal marrow involvement and participants with relapsed multiple myeloma with plasmacytomas
Interventions
Participants will be treated with CC-486 and lenalidomide for 6 cycles
Participants will be treated with CC-486 and lenalidomide for 6 cycles
Radiation therapy will be initiated to the plasmacytoma after cycle 2
Eligibility Criteria
You may qualify if:
- 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.
- 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
- +10 more criteria
You may not qualify if:
- 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:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, 07920, United States
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, 07748, United States
Memorial Sloan Kettering Bergen
Montvale, New Jersey, 07645, United States
Memorial Sloan Kettering Cancer Center @ Commack
Commack, New York, 11725, United States
Memorial Sloan Kettering Westchester
Harrison, New York, 10604, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Memorial Sloan Kettering Nassau
Uniondale, New York, 11553, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Urvi Shah, MD
Memorial Sloan Kettering Cancer Center
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 20, 2019
First Posted
November 22, 2019
Study Start
November 19, 2019
Primary Completion (Estimated)
November 19, 2026
Study Completion (Estimated)
November 19, 2026
Last Updated
December 2, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will share
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.