Clinical trial NCT05495620: Long-term KRd in Relapsed and/or Refractory Multiple Myeloma
Official title: Real-world Evidence of Carfilzomib, Lenalidomide, Dexamethasone Combination Therapy in Korean Relapsed and/or Refractory Multiple Myeloma Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Multiple Myeloma in Relapse
Multiple Myeloma, Refractory
Lead sponsor: Dong-A University Hospital
Sponsor class: OTHER
Collaborators: name: Amgen
First posted: 2022-08-10
Enrollment: 300
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Relapsed and/or refractory multiple myeloma patients treated with carfilzomib-lenalidomide-dexamethasone combination chemotherapy

Brief summary: 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

* PFS difference according to the high-risk disease subgroups and previous treatment
* OS
* Overall response rate and clinical benefit rate
* Duration of response To evaluate the safety and tolerability of KRd in RRMM patients

Detailed description: 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

Eligibility criteria: Inclusion criteria

1. Patients ≥ 19 years
2. Relapsed and/or refractory multiple myeloma patients
3. Patients who had received KRd combination chemotherapy from February, 2018 to February, 2020.

Exclusion criteria

1. Patient who had not been treated with KRd combination therapy from the first cycle of treatment
2. Patients who had received KRd combination chemotherapy before February, 2018 and after February, 2020.

Primary outcomes:
measure: Progression-free survival
timeFrame: up to 54 months
Secondary outcomes:
measure: Overall survival
timeFrame: up to 54 months
measure: Overall response rate, clinical benefit rate
timeFrame: up to 54 months
measure: Duration of response
timeFrame: up to 54 months
measure: Toxicity profile
timeFrame: up to 2 years
Other outcomes:
Locations:
Study officials:
affiliation: Dong-A University Hospital
name: Sung-Hyun Kim, MD, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.