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

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Multiple Myeloma in Relapse; Multiple Myeloma, Refractory
• Intervention / Treatment: Drug: Lenalidomide; Drug: Carfilzomib; Drug: Dexamethasone

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 Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

• Study Contact: Name: Ji Hyun Lee, MD, Ph.D; Phone Number: 82-51-240-2915; Email: hidrleejh@dau.ac.kr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Relapsed and/or refractory multiple myeloma patients treated with carfilzomib-lenalidomide-dexamethasone combination chemotherapy

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Relapsed and/or refractory multiple myeloma; Multiple myeloma in relapsed but not refractory, relapsed and refractory, and primary refractory status	Drug: Lenalidomide; Oral; Other Names: Revlimid; Drug: Carfilzomib; Intravenous carfilzomib, lenalidomide, dexamethasone; Other Names: Kyprolis; Drug: Dexamethasone; Oral or intravenous

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival	the time from the first date of KRd treatment to the time of death or censored date	up to 54 months
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
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
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

Collaborators and Investigators

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

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2022
• Primary Completion (Anticipated): January 31, 2023
• Study Completion (Anticipated): September 30, 2023

Study Registration Dates

• First Submitted: July 5, 2022
• First Submitted That Met QC Criteria: August 8, 2022
• First Posted (Actual): August 10, 2022

Study Record Updates

• Last Update Posted (Actual): August 10, 2022
• Last Update Submitted That Met QC Criteria: August 8, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Immunoproliferative Disorders; Hematologic Diseases; Hemorrhagic Disorders; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Multiple Myeloma; Neoplasms, Plasma Cell; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Immunologic Factors; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Dexamethasone; Lenalidomide
• Other Study ID Numbers: DAUHIRB-22-081

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No