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

Multiple Myeloma in Relapse Clinical Trial

Official title:

Real-world Evidence of Carfilzomib, Lenalidomide, Dexamethasone Combination Therapy in Korean Relapsed and/or Refractory Multiple Myeloma Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05495620
• Other study ID #: DAUHIRB-22-081
• Status: Not yet recruiting
• Start date: August 1, 2022
• Est. completion date: September 30, 2023

Study information

• Verified date: August 2022
• Source: Dong-A University Hospital
• Contact: Ji Hyun Lee, MD, Ph.D
• Phone: 82-51-240-2915
• Email: hidrleejh[@]dau.ac.kr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: September 30, 2023
• Est. primary completion date: January 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Myeloma
• Multiple Myeloma in Relapse
• Multiple Myeloma, Refractory
• Neoplasms, Plasma Cell

Intervention

Drug:
• Carfilzomib
Intravenous carfilzomib, lenalidomide, dexamethasone
• Lenalidomide
Oral
• Dexamethasone
Oral or intravenous

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Dong-A University Hospital	Amgen

References & Publications (1)

Stewart AK, Rajkumar SV, Dimopoulos MA, Masszi T, Špicka 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival	the time from the first date of KRd to the date of disease progression or death or censored date	up to 54 months
Secondary	Overall survival	the time from the first date of KRd treatment to the time of death or censored date	up to 54 months
Secondary	Overall response rate, clinical benefit rate	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	up to 54 months
Secondary	Duration of response	the time from the first date of response to the time of disease progression or death or censored date	up to 54 months
Secondary	Toxicity profile	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	up to 2 years