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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	19 Years and Over
Gender	All

More Inclusion & Exclusion 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05495620
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Dong-A University Hospital
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Sung-Hyun Kim, MD, Ph.D
Principal Investigator Affiliation	Dong-A University Hospital
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other, Industry
Overall Status	Not yet recruiting
Countries
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Multiple Myeloma in Relapse, Multiple Myeloma, Refractory

Additional Details

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 & Interventions

Arms

: Relapsed and/or refractory multiple myeloma

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

Interventions

Drug: - Carfilzomib

Intravenous carfilzomib, lenalidomide, dexamethasone

Drug: - Lenalidomide

Oral

Drug: - Dexamethasone

Oral or intravenous

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

Ji Hyun Lee, MD, Ph.D

hidrleejh@dau.ac.kr

82-51-240-2915

For additional contact information, you can also visit the trial on clinicaltrials.gov.

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