Long-term KRd in Relapsed and/or Refractory Multiple Myeloma
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
To evaluate the effectiveness of investigational treatment strategy by
PFS difference according to the high-risk disease subgroups and previous treatment
Overall response rate and clinical benefit rate
Duration of response To evaluate the safety and tolerability of KRd in RRMM patients
|Condition or Disease||Intervention/Treatment||Phase|
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
Arms and Interventions
|Relapsed and/or refractory multiple myeloma
Multiple myeloma in relapsed but not refractory, relapsed and refractory, and primary refractory status
Intravenous carfilzomib, lenalidomide, dexamethasone
Oral or intravenous
Primary Outcome Measures
- Progression-free survival [up to 54 months]
the time from the first date of KRd to the date of disease progression or death or censored date
Secondary Outcome Measures
- Overall survival [up to 54 months]
the time from the first date of KRd treatment to the time of death or censored date
- Overall response rate, clinical benefit rate [up to 54 months]
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
- Duration of response [up to 54 months]
the time from the first date of response to the time of disease progression or death or censored date
- Toxicity profile [up to 2 years]
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
Patients ≥ 19 years
Relapsed and/or refractory multiple myeloma patients
Patients who had received KRd combination chemotherapy from February, 2018 to February, 2020.
Patient who had not been treated with KRd combination therapy from the first cycle of treatment
Patients who had received KRd combination chemotherapy before February, 2018 and after February, 2020.
Contacts and Locations
LocationsNo locations specified.
Sponsors and Collaborators
- Dong-A University Hospital
- Principal Investigator: Sung-Hyun Kim, MD, Ph.D, Dong-A University Hospital
Study Documents (Full-Text)None provided.
- Stewart AK, Rajkumar SV, Dimopoulos MA, Masszi T, Špička I, Oriol A, Hájek R, Rosiñol 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.