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A Study of Lenalidomide and CC-486 With Radiation Therapy in Patients With Plasmacytoma

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ClinicalTrials.gov Identifier: NCT04174196
Recruitment Status : Recruiting
First Posted : November 22, 2019
Last Update Posted : December 16, 2020
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
Plasmacytoma Plasmacytoma of Bone Multiple Myeloma Drug: CC-486 Drug: Lenalidomide Radiation: Radiation Therapy Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study Evaluating Lenalidomide and CC-486 in Combination With Radiotherapy For Patients With Plasmacytoma (LENAZART Study)
Actual Study Start Date : November 19, 2019
Estimated Primary Completion Date : November 19, 2021
Estimated Study Completion Date : November 19, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Participants with Plasmacytoma
Participants will have solitary bone plasmacytoma with minimal marrow involvement and participants with relapsed multiple myeloma with plasmacytomas
 Drug: CC-486
Participants will be treated with CC-486 and lenalidomide for 6 cycles

Drug: Lenalidomide
Participants will be treated with CC-486 and lenalidomide for 6 cycles

Radiation: Radiation Therapy
Radiation therapy will be initiated to the plasmacytoma after cycle 2


Outcome Measures
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Primary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Cohort 1: Must meet all the following 3 criteria:

  • Histologically confirmed newly diagnosed or recurrent solitary plasmacytoma (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 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.
  • Any prior number of therapies is permitted, including prior radiation therapy
  • Allogeneic transplant patients are permitted

All Cohorts:

  • Age >/= 18 years
  • Clinically safe to delay radiation for at least 2 months
  • 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

Exclusion Criteria:

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:

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04174196


Contacts
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Contact: Urvi Shah, MD 212-639-7016 shahu@mskcc.org
Contact: Alexander Lesokhin, MD 212-639-3069 lesokhia@mskcc.org

Locations
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United States, New Jersey
Memoral Sloan Kettering Basking Ridge Recruiting
Basking Ridge, New Jersey, United States, 07920
Contact: Urvi Shah, MD    212-639-7016      
Memoral Sloan Kettering Monmouth Recruiting
Middletown, New Jersey, United States, 07748
Contact: Urvi Shah, MD    212-639-7016      
Memorial Sloan Kettering Bergen Recruiting
Montvale, New Jersey, United States, 07645
Contact: Urvi Shah, MD    212-639-7016      
United States, New York
Memorial Sloan Kettering Cancer Center @ Commack Recruiting
Commack, New York, United States, 11725
Contact: Urvi Shah, MD    212-639-7016      
Memoral Sloan Kettering Westchester Recruiting
Harrison, New York, United States, 10604
Contact: Urvi Shah, MD    212-639-7016      
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Urvi Shah, MD    212-639-7016      
Memorial Sloan Kettering Nassau Recruiting
Uniondale, New York, United States, 11553
Contact: Urvi Shah, MD    212-639-7016      
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
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Principal Investigator: Urvi Shah, MD Memorial Sloan Kettering Cancer Center
More Information
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Additional Information:

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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT04174196    
Other Study ID Numbers: 19-284
First Posted: November 22, 2019    Key Record Dates
Last Update Posted: December 16, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Memorial Sloan Kettering Cancer Center:
CC-486
Plasmacytoma
lenalidomide
Plasmacytoma of Bone
 Memorial Sloan Kettering Cancer Center
19-284
multiple myeloma with plasmacytomas
multiple myeloma
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Plasmacytoma
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
 Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Lenalidomide
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents