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Active Not Recruiting
NCT04430894
KRDI in Transplant-Eligible MM
Conditions: Multiple Myeloma
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 50
Sponsor: Massachusetts General Hospital
Location: Massachusetts General Hospital Boston Massachusetts
Summary
This research study is testing the efficacy of an experimental drug combination for people with newly diagnosed multiple myeloma that are eligible for a stem cell transplant.
The names of the study drugs involved in this study are:
* Carfilzomib
* Isatuximab
* Lenalidomide
* Dexamethasone
Eligibility Criteria
Inclusion Criteria:
* Subject must be at least 18 years of age.
* Subject must have documented multiple myeloma satisfying the CRAB criteria and measurable disease defined as:
* Monoclonal plasma cells in the bone marrow ≥10% or presence of a biopsy-proven Plasmacytoma.
* Measurable disease as defined by any of the following:
* IgG myeloma: Serum monoclonal paraprotein (M-protein) level ≥.5 g/dL or urine M-protein level ≥200 mg/24 hours; or
* IgA, IgM, or IgD multiple myeloma: serum M-protein level ≥0.25 g/dL or urine M-protein level ≥200 mg/24 hours; or
* Light chain multiple myeloma: Serum immunoglobulin free light chain ≥10 mg/dL and abnormal serum immunoglobulin kappa lambda free light chain ratio.
* Sixty percent or greater clonal plasma cells on bone marrow examination.
* Serum involved / uninvolved free light chain ratio of 100 or greater, provided the absolute level of the involved free light chain is at least 100 mg/L (a patient's "involved" free light chain - either kappa or lambda - is the one that is above the normal reference range; the uninvolved light chain is the one that typically is in, or below, the normal range).
* More than one focal lesion on magnetic resonance image (MRI) that is at least 5 mm or greater in size.
* Newly diagnosed and considered candidate for high-dose chemotherapy with stem cell transplant.
* Subject must have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2.
* Subject must have pretreatment clinical laboratory values meeting the following criteria during the Screening Phase:
* hemoglobin ≥ 7.5 g/dL (≥ mmol/L; prior RBC transfusion or recombinant human erythropoietin use is permitted);
* absolute neutrophil count ≥1.0 x 109/L (granulocyte colony stimulating factor \[GCSF\] use is permitted);
* platelet count ≥70 x 109/L for subjects in whom \50 × 109/L (transfusions are not permitted to achieve this minimum platelet count)
* aspartate aminotransferase (AST) ≤2.5 x upper limit of normal (ULN);
* alanine aminotransferase (ALT) ≤2.5 x ULN;
* total bilirubin ≤2.0 x ULN, except in subjects with congenital bilirubinemia, such as Gilbert syndrome (direct bilirubin ≤2.0 x ULN)
* creatinine clearance ≥30 mL/min
* corrected serum calcium ≤14 mg/dL (≤3.5 mmol/L); or free ionized calcium \
Source: ClinicalTrials.gov (NCT04430894). StuddyBuddy aggregates publicly available trial information.
