RRMM이 있는 노인/허약 대상의 Isa-Pom-Dex

실험적: 싱글 암

연구 치료를 받고 있는 재발성 또는 불응성 다발성 골수종 환자.

의약품: 이사툭시맙

제약 형태: 주입 용액. 투여 경로: 정맥 10 mg/kg을 1주기 동안 매주 1회, 각 후속 주기 동안 격주로 정맥 내 투여합니다.

의약품: 포말리도마이드

약제학적 형태: 경구용 알약. 투여 경로: 3mg 포말리도마이드 3mg 알약은 각 28일 주기의 1-21일에 1일 1회 경구 복용합니다.

의약품: 덱사메타손

약학적 형태: 경구용 정제 투여 경로: 경구용 정제. Dexamethasone 20mg 정제는 일주일에 한 번 입으로 가져갑니다.

Overall Response Rate (ORR)

Overall response rate (ORR) is defined as the percentage of participants achieving a partial response or better (≥PR) per IMWG criteria. The number and percentage of participants achieving at least a partial response were reported.

Complete response (CR) requires negative serum and urine immunofixation, disappearance of plasmacytomas, and <5% bone marrow plasma cells; stringent complete response (sCR) requires CR plus a normal free light chain ratio and no clonal plasma cells in bone marrow. Very good partial response (VGPR) is defined as M-protein detectable by immunofixation but not electrophoresis, or a ≥90% reduction in serum M-protein with urine M-protein <100 mg/24h. Partial response (PR) is defined as a ≥50% reduction in serum M-protein and a ≥90% reduction in 24-hour urine M-protein (or to <200 mg/24h), with a ≥50% reduction in plasmacytomas if present at baseline.

Treatment Related Adverse Events Rate

All treatment-related adverse events as defined by changes from baseline utilizing National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) criteria version 5.0.

NCI-CTCAE is a descriptive terminology utilized for AE reporting. A grading (severity) scale is provided for each AE term. Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local, or noninvasive intervention indicated; limiting age-appropriate instrumental Activities of Daily Living (ADL). Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL. Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE.

Treatment Failure-free Survival (TFFS)

TFFS is defined as the time start from the first day of study therapy until discontinuation for any reason, including disease progression, toxicity, or death.

Progressive disease: Serum M-protein: absolute increase must be ≥ 0.5 g/dL, ≥ 1 g/dL if the lowest M component was ≥ 5 g/dL; absolute Urine M-protein increase≥ 200 mg/24 h). In patients without measurable serum and urine M-protein levels, the difference between involved and uninvolved FLC levels must be > 10 mg/dL; without measurable involved FLC levels, bone marrow plasma cell percentage irrespective of baseline status Appearance of a new lesion(s), ≥ 50% increase from nadir > 1 lesion, or ≥ 50% increase in the longest diameter of a previous lesion >1 cm in short axis;≥ 50% increase e in circulating plasma cells (minimum of 200 cells per μL) if this is the only measure of disease.

Maximum Depth of Response

Maximum depth of response includes the summation of minimal response (MR), partial response (PR), very good partial response (VGPR), complete response (CR), and stringent complete response (sCR) based on IMWG criteria. Minimal response(MR): ≥ 25% but ≤ 49% reduction of serum M-protein and reduction in 24-h urine M-protein by 50-89%, if present at baseline, a ≥ 50% reduction in the size of soft tissue plasmacytomas is also required. PR, VGPR, CR, and sCR were defined above.

Clinical Benefit Rate (CBR)

CBR is defined as a partial response or better (≥PR) + minimal response (MR) rate based on International Myeloma Working Group (IMWG) criteria.

Bone Marrow Minimal Residual Disease (MRD) Negativity

Bone marrow minimal residual disease (MRD) negativity will be defined as the ratio of subjects who achieved MRD to all subjects. MRD negativity will be assessed by next-generation sequencing with a minimum sensitivity of 1x10-5.

Time to First Response

Time to first response is defined as the time from the first study treatment to the achievement of PR or better as defined by IMWG criteria.

Time to Best Response

Time to best response is defined as the time from the first study treatment to the achievement of best response (PR, VGPR, CR, or sCR) based on IMWG criteria.

Duration of Response

Duration of response is defined as the time from the achievement of PR or better until progressive disease (PD) based on IMWG criteria. Subjects will be censored if they die of anything other than myeloma.

Progression-free Survival (PFS)

PFS is defined as the time from the first study treatment until confirmed PD based on IMWG criteria or death from any cause, whichever comes first.

Median Time to Next Treatment (TTNT)

Median time to next treatment (TTNT) is defined as the time from the start of the study treatment to the next type of Multiple Myeloma treatment or death from any cause, whichever occurs first.

Overall Survival

Overall survival is defined as the time from the first study treatment to death from any cause.