Belantamab mafodotin (Blenrep): 벨란타맴 마포도틴 은 최종적으로 생존률 개선이 되지않아 FDA 요청으로 2022년 11월 22일 부로 시중에서 시판이 중지되었습니다. Belantamab mafodotin (Blenrep): a monoclonal antibody conjugate against BCMA will be withdrawn from marketing as of 11/22/2022 at the request of the U.S. FDA. This request was based on the outcome of the DREAMM-3 phase III confirmatory trial, which did not meet the requirements of the U.S. FDA Accelerated Approval regulations. The drug was given speedy approval by the FDA in 2020 and approved for patients with relapsed or refractory multiple myeloma who received at least four previous therapies.
NCCN guidelines update for multiple myeloma treatment NCCN recommends the following primary therapies for transplant candidates8: * Bortezomib + lenalidomide + dexamethasone (preferred, Category 1) * Carfilzomib + lenalidomide + dexamethasone (preferred, Category 2A) * Daratumumab + lenalidomide + bortezomib + dexamethasone (other recommended) NCCN also provides multiple alternative primary therapy regimens that are useful in certain circumstances. Following primary therapy, NCCN recommends maintenance therapy with lenalidomide (preferred, Category 1), bortezomib (other recommended, Category 2A), daratumumab (other recommended, Category 2A), or ixazomib (other recommended, category 2B). Patients With Newly Diagnosed MM Ineligible for HDT and ASCT For patients who are not candidates for transplantation, the NCCN recommends the following primary therapies: * Bortezomib + lenalidomide + dexamethasone (preferred, Category 1) * Daratumumab + lenalidomide + dexamethasone (preferred, Category 1) * Daratumumab + bortezomib + melphalan + prednisone (other recommended, Category 1) * Carfilzomib + lenalidomide + dexamethasone (other recommended) * Ixazomib + lenalidomide + dexamethasone (other recommended) * Daratumumab + cyclophosphamide + bortezomib + dexamethasone (other recommended) Following primary therapy, NCCN recommends maintenance therapy with lenalidomide (preferred, Category 1), ixazomib (other recommended, category 2B), bortezomib (other recommended, category 2A), or bortezomib + lenalidomide (useful in certain circumstances, Category 2A). Refractory/Relapsed Disease The NCCN guidelines provide multiple treatment options for patients with RRMM, with treatment recommendations divided into early relapse (1 to 3 prior therapies) and late relapse (> 3 prior therapies). Of note, patients who did not receive ASCT or who had a prolonged response to ASCT should be considered for ASCT. Early Relapse (1 to 3 prior therapies) If a patient was treated with an induction regimen and then relapsed after > 6 months, that same regimen may be repeated. Patients with lenalidomide-refractory disease should be considered for a lenalidomide-free triplet regimen. NCCN Guidelines provide a comprehensive list of preferred, recommended, and useful regimens for early relapses. Preferred regimens for early relapse include ixazomib + lenalidomide + dexamethasone (Category 1) and bortezomib + lenalidomide + dexamethasone (Category 2A). NCCN notes, however, that for patients who are still sensitive to bortezomib and/or lenalidomide, any of these regimens may be appropriate. The remaining preferred regimens are divided into the bortezomib-refractory category and the lenalidomide-refractory category. NCCN also provides recommendations based on how many therapies a patient has received and which type; clinicians should consult the latest NCCN guidelines for detailed instructions. Bortezomib-refractory regimens8: * Daratumumab + lenalidomide + dexamethasone (Category 1) * Daratumumab + carfilzomib + dexamethasone (Category 1) * Carfilzomib + lenalidomide + dexamethasone (Category 1) * Isatuximab-irfc + carfilzomib + dexamethasone (Category 1) * Carfilzomib + pomalidomide + dexamethasone Lenalidomide-refractory regimens: * Daratumumab + carfilzomib + dexamethasone (Category 1) * Daratumumab + bortezomib + dexamethasone (Category 1) * Isatuximab-irfc + carfilzomib + dexamethasone (Category 1) * Carfilzomib + pomalidomide + dexamethasone Late Relapse (> 3 prior therapies) For patients who have been treated with > 3 therapies, NCCN recommends bendamustine, bendamustine + bortezomib + dexamethasone, bendamustine + carfilzomib + dexamethasone, bendamustine + lenalidomide + dexamethasone, or high-dose or fractionated cyclophosphamide (all Category 2A recommendations).8 Patients with late relapses who have received at least 4 prior therapies (including an anti-CD38 monoclonal antibody, a PI, and an immunomodulatory agent) may be treated with any of the following: * Belantamab mafodotin-blmf (an ADC that targets BCMA) * Idecabtagene vicleucel (a cell-based gene therapy) * Ciltacabtagene autoleucel (a cell-based gene therapy) * Teclistamab-cqyv (ahuman bispecific monoclonal antibody) For patients who have received at least 4 prior therapies and whose disease is refractory to a least 2 PIs, at least 2 immunomodulatory agents, and an anti-CD38 monoclonal antibody, NCCN recommends selinexor + dexamethasone.
선생님 안녕하세요. 저희 엄마는 어깨부분, 허리 그리고 엉덩이, 뒷 허벅지부분까지 아파하셔서 누웟을때 일어나기, 앉고 일어설때 많이 힘들어하십니다. 신경외과로 먼저 가게되었고 , 류마티스과로 트랜스퍼되어서 혈액검사를 진행했는데 백혈구 적혈구 수치 모두 정상 , 혈액 내 칼슘 농도도 정상이었어요. 다만 빈혈이 조금 심하고 혈액 염증수치가 높다고 하셔서 다시 혈액검사와 ct촬영을 앞두고있어요. 증상이 다발성골수종과 너무 비슷해서 미친듯이 걱정하고있는데요… 지금 현재 혈액 검사 내용으로 교수님이 보실때 안전한 수준인건지 궁금합니다..
2022년 10월 25일, Teclistamab (테클리스타맵) 이 FDA 승인을 받았습니다. 재발한 다발성 골수종 환자 60% 이상에서 효과가 있습니다. 효가가 약 1년 지속되고 생존율이 약 2년 정도 보고 되었습니다. On October 25, 2022, the Food and Drug Administration granted accelerated approval to teclistamab-cqyv (Tecvayli, Janssen Biotech, Inc.), the first bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager, for adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. Teclistamab-cqyv was evaluated in MajesTEC-1 (NCT03145181; NCT04557098), a single-arm, multi-cohort, open-label, multi-center study. The efficacy population consisted of 110 patients who had previously received at least 3 prior therapies, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody, and had not received prior BCMA-targeted therapy. The main efficacy outcome measure was overall response rate (ORR) as determined by the Independent Review Committee assessment using International Myeloma Working Group 2016 criteria. ORR was 61.8% (95% CI: 52.1, 70.9). With a median follow-up of 7.4 months among responders, the estimated duration of response (DOR) rate was 90.6% (95% CI: 80.3%, 95.7%) at 6 months and 66.5% (95% CI: 38.8%, 83.9%) at 9 months. The prescribing information for teclistamab-cqyv has a Boxed Warning for life threatening or fatal cytokine release syndrome (CRS) and neurologic toxicity, including immune effector cell-associated neurotoxicity (ICANS). Among patients who received teclistamab-cqyv at the recommended dose, CRS occurred in 72% of patients, neurologic toxicity in 57%, and ICANS in 6%. Grade 3 CRS occurred in 0.6% of patients and Grade 3 or 4 neurologic toxicity occurred in 2.4%. Because of the risks of CRS and neurologic toxicity, including ICANS, teclistamab-cqyv is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS), called the Tecvayli REMS. The most common adverse reactions (≥20%) occurring in the 165 patients in the safety population, were pyrexia, CRS, musculoskeletal pain, injection site reaction, fatigue, upper respiratory tract infection, nausea, headache, pneumonia, and diarrhea. The most common Grade 3 to 4 laboratory abnormalities (≥20%) were decreased lymphocytes, decreased neutrophils, decreased white blood cells, decreased hemoglobin, and decreased platelets. The recommended teclistamab-cqyv dose is 0.06 mg/kg via subcutaneous injection on Day 1, 0.3 mg/kg on Day 4, and 1.5 mg/kg on Day 7, followed by 1.5 mg/kg once weekly until disease progression or unacceptable toxicity.
남자친구가 현재 42살입니다 다발골수종을 2020년 7월말에 진단받고 2021년 2월에 자가 조혈모세포이식후 만 1년이 지났습니다 현재는 유지요법으로 항암약을 복용하고 있구여 한 1년 정도 더 복용하면 됩니다 약을 복용하는 동안은 얼굴 혈색이 회색빛을 띄고 약을 끊으면 혈색이 정상적으로 돌아옵니다 현재는 일상생활도 조금씩 할 정도로 많이 호전 됐는데 더 좋아졌으면 합니다 . 생존율이 사람마다 다르지만 통계학적으로 얼마동안 유지되는지 궁금합니다
고위험 무증상골수종 환자일 경우 해 볼만 합니다. - 염색체 고위험 변형 : 4;14 전좌, 17 번 절제가 있을 때 - 골수 침범 20% 이상 - M 단백 4 g 이상 - 카파 람다 경쇄 비율이 8 이상 일때 담당의사님과 상의하여 위의 고위험 조건에 있는지 알아보시고 있다면 고려 해 볼만 합니다
![[따뜻한환자이야기] 기대 수명이 5년? 4번의 재발.. 원인 모를 고통에 정확한 진단도 어려운 혈액암 다발골수종, 두 환우의 다발골수종 일대기를 소개합니다](http://i.ytimg.com/vi/yyUeNJF3GRg/mqdefault.jpg)
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보호자입니다. 환우회카페에서 추천한 글을 보고 들어왔습니다. 미국 치료법이 궁금했는데 좋은 영상 감사드립니다!
안녕하셔요 박사님.
귀한 시간 내주셔서 쉽게 이해할 수 있도록 영상 올려주셔서 진심으로 감사 드립니다.
Belantamab mafodotin (Blenrep): 벨란타맴 마포도틴 은 최종적으로 생존률 개선이 되지않아 FDA 요청으로 2022년 11월 22일 부로 시중에서 시판이 중지되었습니다.
Belantamab mafodotin (Blenrep): a monoclonal antibody conjugate against BCMA will be withdrawn from marketing as of 11/22/2022 at the request of the U.S. FDA. This request was based on the outcome of the DREAMM-3 phase III confirmatory trial, which did not meet the requirements of the U.S. FDA Accelerated Approval regulations.
The drug was given speedy approval by the FDA in 2020 and approved for patients with relapsed or refractory multiple myeloma who received at least four previous therapies.
아버지께서 최근 MGUS 진단을 받으셨어요...좋은 치료법, 치료제 등이 더욱 개선되고 나왔기를 바래봅니다...또한 혈액암으로 진전되지 않기를 🙏
감사합니다.
남편이 Vrd로 치료시작했습니다.
D-vdt 로 할줄알았는데
Vrd로 하신다네요.
어떤 차이점이 있을까요?
D-VRD 도 많이 합니다. 그러나 VRD 만으로도 괜찮습니다
박사님 항상 카페에서 쉽게 설명해주셔서 감사합니다
박사님 좋은 영상감사합니다
현재 저희 부친은 71살이며 다발골수종 만2년3개월째 치료중입니다
지금 krd로 치료중이고 주기적 검사결과 주치의께서 다발골수종이 잘치료된다고 합니다
허나 krd 치료가 진행되는 과정에서 심장에 많은 무리가 가중되어 항암주사를 맞은후 24~48시간정도 호흡 곤란이 있습니다
심장에 부작용이 있을시에는 어떻게 대처해야 하는지 알수 있을까요?
KRd는 좋은 치료법입니다. 그러나 심장 부작용이 있어요. 너무 심하면 VRd 로 바꾸실 수 있고 혹은 R 과 K 용량을 줄여 사용해 볼 수도 있습니다.
보통 치료전에 수액을 너무많이 주어 심장 부전증이나 폐에 물이 차서 그럴 수 있으므로 얼마나 수액을 주는지 알아보시고 콩팥장애가 없다면 수액의 양을 줄이면 훨씬 날겁니다.
@@stanleykim1924 현재 아산병원에서 치료ㅡ 중인데 심장 호흡곤란 부작용으로 3개월째 항암주사를 쉬고 있습니다
항암 쉬는동안 다발골수종이 확산되지 않을 까 걱정이 됩니다
답변해 주셔서 정말 감사합니다~
NCCN guidelines update for multiple myeloma treatment
NCCN recommends the following primary therapies for transplant candidates8:
* Bortezomib + lenalidomide + dexamethasone (preferred, Category 1)
* Carfilzomib + lenalidomide + dexamethasone (preferred, Category 2A)
* Daratumumab + lenalidomide + bortezomib + dexamethasone (other recommended)
NCCN also provides multiple alternative primary therapy regimens that are useful in certain circumstances. Following primary therapy, NCCN recommends maintenance therapy with lenalidomide (preferred, Category 1), bortezomib (other recommended, Category 2A), daratumumab (other recommended, Category 2A), or ixazomib (other recommended, category 2B).
Patients With Newly Diagnosed MM Ineligible for HDT and ASCT
For patients who are not candidates for transplantation, the NCCN recommends the following primary therapies:
* Bortezomib + lenalidomide + dexamethasone (preferred, Category 1)
* Daratumumab + lenalidomide + dexamethasone (preferred, Category 1)
* Daratumumab + bortezomib + melphalan + prednisone (other recommended, Category 1)
* Carfilzomib + lenalidomide + dexamethasone (other recommended)
* Ixazomib + lenalidomide + dexamethasone (other recommended)
* Daratumumab + cyclophosphamide + bortezomib + dexamethasone (other recommended)
Following primary therapy, NCCN recommends maintenance therapy with lenalidomide (preferred, Category 1), ixazomib (other recommended, category 2B), bortezomib (other recommended, category 2A), or bortezomib + lenalidomide (useful in certain circumstances, Category 2A).
Refractory/Relapsed Disease
The NCCN guidelines provide multiple treatment options for patients with RRMM, with treatment recommendations divided into early relapse (1 to 3 prior therapies) and late relapse (> 3 prior therapies). Of note, patients who did not receive ASCT or who had a prolonged response to ASCT should be considered for ASCT.
Early Relapse (1 to 3 prior therapies)
If a patient was treated with an induction regimen and then relapsed after > 6 months, that same regimen may be repeated. Patients with lenalidomide-refractory disease should be considered for a lenalidomide-free triplet regimen. NCCN Guidelines provide a comprehensive list of preferred, recommended, and useful regimens for early relapses.
Preferred regimens for early relapse include ixazomib + lenalidomide + dexamethasone (Category 1) and bortezomib + lenalidomide + dexamethasone (Category 2A). NCCN notes, however, that for patients who are still sensitive to bortezomib and/or lenalidomide, any of these regimens may be appropriate. The remaining preferred regimens are divided into the bortezomib-refractory category and the lenalidomide-refractory category. NCCN also provides recommendations based on how many therapies a patient has received and which type; clinicians should consult the latest NCCN guidelines for detailed instructions.
Bortezomib-refractory regimens8:
* Daratumumab + lenalidomide + dexamethasone (Category 1)
* Daratumumab + carfilzomib + dexamethasone (Category 1)
* Carfilzomib + lenalidomide + dexamethasone (Category 1)
* Isatuximab-irfc + carfilzomib + dexamethasone (Category 1)
* Carfilzomib + pomalidomide + dexamethasone
Lenalidomide-refractory regimens:
* Daratumumab + carfilzomib + dexamethasone (Category 1)
* Daratumumab + bortezomib + dexamethasone (Category 1)
* Isatuximab-irfc + carfilzomib + dexamethasone (Category 1)
* Carfilzomib + pomalidomide + dexamethasone
Late Relapse (> 3 prior therapies)
For patients who have been treated with > 3 therapies, NCCN recommends bendamustine, bendamustine + bortezomib + dexamethasone, bendamustine + carfilzomib + dexamethasone, bendamustine + lenalidomide + dexamethasone, or high-dose or fractionated cyclophosphamide (all Category 2A recommendations).8
Patients with late relapses who have received at least 4 prior therapies (including an anti-CD38 monoclonal antibody, a PI, and an immunomodulatory agent) may be treated with any of the following:
* Belantamab mafodotin-blmf (an ADC that targets BCMA)
* Idecabtagene vicleucel (a cell-based gene therapy)
* Ciltacabtagene autoleucel (a cell-based gene therapy)
* Teclistamab-cqyv (ahuman bispecific monoclonal antibody)
For patients who have received at least 4 prior therapies and whose disease is refractory to a least 2 PIs, at least 2 immunomodulatory agents, and an anti-CD38 monoclonal antibody, NCCN recommends selinexor + dexamethasone.
박사님 박셀바이오의 박셀 평가해주실수 있을까요?임상1상 11명 임상중에 2016년부터 10명 생존해있는데 한번 들여다봐 주세요 감사합니다.
선생님 안녕하세요. 저희 엄마는 어깨부분, 허리 그리고 엉덩이, 뒷 허벅지부분까지 아파하셔서 누웟을때 일어나기, 앉고 일어설때 많이 힘들어하십니다.
신경외과로 먼저 가게되었고 ,
류마티스과로 트랜스퍼되어서
혈액검사를 진행했는데 백혈구 적혈구 수치 모두 정상 , 혈액 내 칼슘 농도도 정상이었어요. 다만 빈혈이 조금 심하고 혈액 염증수치가 높다고 하셔서 다시 혈액검사와 ct촬영을 앞두고있어요. 증상이 다발성골수종과 너무 비슷해서 미친듯이 걱정하고있는데요… 지금 현재 혈액 검사 내용으로 교수님이 보실때 안전한 수준인건지 궁금합니다..
14프로 이상의
다발 골수종 환자가 20년 이상 장기생존 하신다고 하셨는데. 전부 항암치료 후 그렇게 지내시는건 가요? 아니면 치료
하지 않고 그냥 내버려둬도 그렇게
돤다는 말씀 이신가요??
치료 하면서죠
2022년 10월 25일, Teclistamab (테클리스타맵) 이 FDA 승인을 받았습니다. 재발한 다발성 골수종 환자 60% 이상에서 효과가 있습니다. 효가가 약 1년 지속되고 생존율이 약 2년 정도 보고 되었습니다.
On October 25, 2022, the Food and Drug Administration granted accelerated approval to teclistamab-cqyv (Tecvayli, Janssen Biotech,
Inc.), the first bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager, for adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.
Teclistamab-cqyv was evaluated in MajesTEC-1 (NCT03145181; NCT04557098), a single-arm, multi-cohort, open-label, multi-center study. The efficacy population consisted of 110 patients who had previously received at least 3 prior therapies, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody, and had not received prior BCMA-targeted therapy.
The main efficacy outcome measure was overall response rate (ORR) as determined by the Independent Review Committee assessment using International Myeloma Working Group 2016 criteria. ORR was 61.8% (95% CI: 52.1, 70.9). With a median follow-up of 7.4 months among responders, the estimated duration of response (DOR) rate was 90.6% (95% CI: 80.3%, 95.7%) at 6 months and 66.5% (95% CI: 38.8%, 83.9%) at 9 months.
The prescribing information for teclistamab-cqyv has a Boxed Warning for life threatening or fatal cytokine release syndrome (CRS) and neurologic toxicity, including immune effector cell-associated neurotoxicity (ICANS). Among patients who received teclistamab-cqyv at the recommended dose, CRS occurred in 72% of patients, neurologic toxicity in 57%, and ICANS in 6%. Grade 3 CRS occurred in 0.6% of patients and Grade 3 or 4 neurologic toxicity occurred in 2.4%.
Because of the risks of CRS and neurologic toxicity, including ICANS, teclistamab-cqyv is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS), called the Tecvayli REMS.
The most common adverse reactions (≥20%) occurring in the 165 patients in the safety population, were pyrexia, CRS, musculoskeletal pain, injection site reaction, fatigue, upper respiratory tract infection, nausea, headache, pneumonia, and diarrhea. The most common Grade 3 to 4 laboratory abnormalities (≥20%) were decreased lymphocytes, decreased neutrophils, decreased white blood cells, decreased hemoglobin, and decreased platelets.
The recommended teclistamab-cqyv dose is 0.06 mg/kg via subcutaneous injection on Day 1, 0.3 mg/kg on Day 4, and 1.5 mg/kg on Day 7, followed by 1.5 mg/kg once weekly until disease progression or unacceptable toxicity.
아버님께서 이 병으로 확진후 1년도 안되서 돌아가셨습니다. 무서운 병이더군요.
CarT가 이 병을 재발없는 완치가 가능힌가요?
임상시험에서 아주 우수한 효과가 보고되었습니다. 위 유튜브 강의 마지막에 언급이 되었습니다
어머니께서 이번에 다발성 골수종을 진단받으셨습니다... 글쓴이님께 아픈 상처인줄 알지만은 혹시 어떤사유로 떠나셨는지 알수있을까요...!??
남자친구가 현재 42살입니다
다발골수종을 2020년 7월말에 진단받고
2021년 2월에 자가 조혈모세포이식후
만 1년이 지났습니다
현재는 유지요법으로 항암약을 복용하고 있구여
한 1년 정도 더 복용하면 됩니다
약을 복용하는 동안은 얼굴 혈색이 회색빛을 띄고 약을 끊으면 혈색이 정상적으로 돌아옵니다
현재는 일상생활도 조금씩 할 정도로 많이 호전 됐는데 더 좋아졌으면 합니다 .
생존율이 사람마다 다르지만
통계학적으로 얼마동안 유지되는지 궁금합니다
박사님 안녕하세요?
정말 열심히 살아온 남편인데 갑자기 다발성골수종 혈액암을 진단 받았습니다.
현재 항암 1차 맞으려고 준비중인데요.
첫치료가 아주 중요하다고 들었는데.
어떻게 해야할지 난감합니다.
어떻게 해야할까요?
너무 걱정마시고 치료 받도록 하셔요. 늦을 수록 암세포가 자라면서 뼈를 갉아먹기 때문입니다. 잘 치료하면 10 년 이상 살 수 있어요
박사님
제가 다발골수종 진단을 받았고 0기라고 했습니다 1기 이후로 진행하는 것을 막기 위한 치료로서 레날리도마이드와 이사툭시맵을 함께 처방받는 임상연구치료가 있는데 이를 받아볼 것인지 1개월 후 진료받을 때 의견을 달라고 하는데 어떻게 하는게 좋은지 궁금합니다
고위험 무증상골수종 환자일 경우 해 볼만 합니다.
- 염색체 고위험 변형 : 4;14 전좌, 17 번 절제가 있을 때
- 골수 침범 20% 이상
- M 단백 4 g 이상
- 카파 람다 경쇄 비율이 8 이상 일때
담당의사님과 상의하여 위의 고위험 조건에 있는지 알아보시고 있다면 고려 해 볼만 합니다
@@stanleykim1924 교수님 답변 감사합니다
담당의사님에 이와 같은 내용을 확인해서 판단하는데 많은 참고가 될 것 같습니다
그런데 교수님께서 말씀하신 요건을 모두 충족해야 고위험무증상골수종에 해당되고 치료해볼만 하다는 말씀이신지요
한가지라도 있으면 고 위험인데 고위험인자가 많을 수록 더 고 위험이 됩니다
골수종은 다른방법으로 치료해야 됩니다 안전한 방법를 개발하고 있습니다
박사님 저희 남편은 다발성골수염 진단은 받았는데 골수검사결과 항암치료할정도는 아니라고 경과를 지켜보자고 하는데 경과늘 계속지켜보자는 결과가 마냥 좋은결과는 아니네요..시간 싸움인지 어떻게 할수없는게 참 힘드네요
다발성골수종은 가능하면 빨리 치료합니다.
아마 무증상골수증 진단 일 거에요. 무증상골수종은 정기적으로 관찰만 해도 됩니다. 1년에 약 10% 무증상골수종 환자들이 치료가 필요한 다발성 골수종으로 진행됩니다.
골수겁사 소견, 엠단백 수치, 경쇄 수치, 알려주세요