Long-term KRd in Relapsed and/or Refractory Multiple Myeloma

Sponsor
Dong-A University Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05495620
Collaborator
Amgen (Industry)
300
14

Study Details

Study Description

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

Study Design

Study Type:
Observational
Anticipated Enrollment :
300 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Real-world Evidence of Carfilzomib, Lenalidomide, Dexamethasone Combination Therapy in Korean Relapsed and/or Refractory Multiple Myeloma Patients
Anticipated Study Start Date :
Aug 1, 2022
Anticipated Primary Completion Date :
Jan 31, 2023
Anticipated Study Completion Date :
Sep 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Relapsed and/or refractory multiple myeloma

Multiple myeloma in relapsed but not refractory, relapsed and refractory, and primary refractory status

Drug: Carfilzomib
Intravenous carfilzomib, lenalidomide, dexamethasone
Other Names:
  • Kyprolis
  • Drug: Lenalidomide
    Oral
    Other Names:
  • Revlimid
  • Drug: Dexamethasone
    Oral or intravenous

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. Overall survival [up to 54 months]

      the time from the first date of KRd treatment to the time of death or censored date

    2. 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

    3. 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

    4. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Dong-A University Hospital
    • Amgen

    Investigators

    • Principal Investigator: Sung-Hyun Kim, MD, Ph.D, Dong-A University Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Sung-Hyun Kim, Professor, Dong-A University Hospital
    ClinicalTrials.gov Identifier:
    NCT05495620
    Other Study ID Numbers:
    • DAUHIRB-22-081
    First Posted:
    Aug 10, 2022
    Last Update Posted:
    Aug 10, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 10, 2022