Multiple Myeloma, Plasmacytoma, Plasmacytoma of Bone
Conditions
Keywords
CC-486, Plasmacytoma, lenalidomide, Plasmacytoma of Bone, Memorial Sloan Kettering Cancer Center, 19-284, multiple myeloma with plasmacytomas, multiple myeloma
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.
Interventions
DRUGCC-486
Participants will be treated with CC-486 and lenalidomide for 6 cycles
DRUGLenalidomide
Participants will be treated with CC-486 and lenalidomide for 6 cycles
RADIATIONRadiation Therapy
Radiation therapy will be initiated to the plasmacytoma after cycle 2
Sponsors
Memorial Sloan Kettering Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 \</= 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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measure Complete Response | 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 |
Countries
United States
Outcome results
None listed