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| Name | Class |
|---|---|
| Amgen | INDUSTRY |
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Research question: Is KRd therapy effective and safe in the real-world Asian patients?
Primay objective: To evaluate the effectiveness of KRd in RRMM patients
Secondary objectives:
To evaluate the effectiveness of investigational treatment strategy by
Key study variables:
Demographic data, ISS, R-ISS, cytogenetic abnormalities on FISH and G-banding, previous treatment regimens, response to previous treatment regimens, existence of extramedullary plasmacytoma, MM-related symptoms, whether or not M protein has increased twice or more in 2-3 months at the time of KRd commencement, response to KRd therapy, duration of KRd treatment, adverse events during KRd therapy, disease progression and progression date, survival, and censored date or day of death
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Relapsed and/or refractory multiple myeloma | Multiple myeloma in relapsed but not refractory, relapsed and refractory, and primary refractory status |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Carfilzomib | Drug | Intravenous carfilzomib, lenalidomide, dexamethasone |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival | the time from the first date of KRd to the date of disease progression or death or censored date | up to 54 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | the time from the first date of KRd treatment to the time of death or censored date | up to 54 months |
| Overall response rate, clinical benefit rate | the proportion of patients who achieved a PR or better, which response is defined by the IMWG criteria, the proportion of patients who achieved a MR or better |
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Inclusion criteria
Exclusion criteria
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Relapsed and/or refractory multiple myeloma patients treated with carfilzomib-lenalidomide-dexamethasone combination chemotherapy
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ji Hyun Lee, MD, Ph.D | Contact | 82-51-240-2915 | hidrleejh@dau.ac.kr |
| Name | Affiliation | Role |
|---|---|---|
| Sung-Hyun Kim, MD, Ph.D | Dong-A University Hospital | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25482145 | Background | Stewart AK, Rajkumar SV, Dimopoulos MA, Masszi T, Spicka I, Oriol A, Hajek R, Rosinol L, Siegel DS, Mihaylov GG, Goranova-Marinova V, Rajnics P, Suvorov A, Niesvizky R, Jakubowiak AJ, San-Miguel JF, Ludwig H, Wang M, Maisnar V, Minarik J, Bensinger WI, Mateos MV, Ben-Yehuda D, Kukreti V, Zojwalla N, Tonda ME, Yang X, Xing B, Moreau P, Palumbo A; ASPIRE Investigators. Carfilzomib, lenalidomide, and dexamethasone for relapsed multiple myeloma. N Engl J Med. 2015 Jan 8;372(2):142-52. doi: 10.1056/NEJMoa1411321. Epub 2014 Dec 6. |
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| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
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| ID | Term |
|---|---|
| C524865 | carfilzomib |
| D000077269 | Lenalidomide |
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D010797 | Phthalimides |
| D010795 | Phthalic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
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| Lenalidomide | Drug | Oral |
|
|
| Dexamethasone | Drug | Oral or intravenous |
|
| up to 54 months |
| Duration of response | the time from the first date of response to the time of disease progression or death or censored date | up to 54 months |
| Toxicity profile | toxicities as determined by the incidence of clinical and laboratory findings occurred from the time of the first date of KRd treatment to the date of disease progression or death or censored date | up to 2 years |
| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D009930 |
| Organic Chemicals |
| D010881 | Piperidones |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D054833 | Isoindoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |