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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

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
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.
  • - Serum bilirubin levels
Higher levels are acceptable if these can be attributed to active hemolysis or ineffective erythropoiesis of Gilbert's syndrome.
  • - AST (SGOT) and ALT (SGPT)
  • - 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04174196
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Memorial Sloan Kettering Cancer Center
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Urvi Shah, MD
Principal Investigator Affiliation Memorial Sloan Kettering Cancer Center
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Plasmacytoma, Plasmacytoma of Bone, Multiple Myeloma
Study Website: View Trial Website
Arms & Interventions

Arms

Experimental: Participants with Plasmacytoma

Participants will have solitary bone plasmacytoma with minimal marrow involvement and participants with relapsed multiple myeloma with plasmacytomas

Interventions

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Memoral Sloan Kettering Basking Ridge, Basking Ridge, New Jersey

Status

Recruiting

Address

Memoral Sloan Kettering Basking Ridge

Basking Ridge, New Jersey, 07920

Site Contact

Urvi Shah, MD

shahu@mskcc.org

212-639-7016

Memoral Sloan Kettering Monmouth, Middletown, New Jersey

Status

Recruiting

Address

Memoral Sloan Kettering Monmouth

Middletown, New Jersey, 07748

Site Contact

Urvi Shah, MD

shahu@mskcc.org

212-639-7016

Memorial Sloan Kettering Bergen, Montvale, New Jersey

Status

Recruiting

Address

Memorial Sloan Kettering Bergen

Montvale, New Jersey, 07645

Site Contact

Urvi Shah, MD

shahu@mskcc.org

212-639-7016

Commack, New York

Status

Recruiting

Address

Memorial Sloan Kettering Cancer Center @ Commack

Commack, New York, 11725

Site Contact

Urvi Shah, MD

shahu@mskcc.org

212-639-7016

Memoral Sloan Kettering Westchester, Harrison, New York

Status

Recruiting

Address

Memoral Sloan Kettering Westchester

Harrison, New York, 10604

Site Contact

Urvi Shah, MD

shahu@mskcc.org

212-639-7016

Memorial Sloan Kettering Cancer Center, New York, New York

Status

Recruiting

Address

Memorial Sloan Kettering Cancer Center

New York, New York, 10065

Site Contact

Urvi Shah, MD

shahu@mskcc.org

212-639-7016

Memorial Sloan Kettering Nassau, Uniondale, New York

Status

Recruiting

Address

Memorial Sloan Kettering Nassau

Uniondale, New York, 11553

Site Contact

Urvi Shah, MD

shahu@mskcc.org

212-639-7016