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

Dong-A University Hospital

Status: Not yet enrolling

Conditions: Multiple Myeloma in Relapse; Multiple Myeloma, Refractory

Treatments: Drug: Lenalidomide; Drug: Dexamethasone; Drug: Carfilzomib

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05495620

DAUHIRB-22-081

Details and patient eligibility

About

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

Full 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

Enrollment: 300 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion and 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 design

300 participants in 1 patient group

Relapsed and/or refractory multiple myeloma

Description:

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

Treatment:

Drug: Carfilzomib

Drug: Dexamethasone

Drug: Lenalidomide