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

NCT05495620 | Unknown DMC

• 1 other identifier: DAUHIRB-22-081
• Study Type: observational
• Target: 300
• Locations: 0 countries
• Sites: N/A

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

Conditions

Multiple Myeloma in Relapse; Multiple Myeloma, Refractory

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Overall survival

  up to 54 months

• Overall response rate, clinical benefit rate

  up to 54 months

• Duration of response

  up to 54 months

• Toxicity profile

  up to 2 years

Study Arms (1)

Relapsed and/or refractory multiple myeloma

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

Drug: Carfilzomib; Drug: Lenalidomide; Drug: Dexamethasone

Interventions

Carfilzomib DRUG

Intravenous carfilzomib, lenalidomide, dexamethasone

Also known as: Kyprolis

Relapsed and/or refractory multiple myeloma

Lenalidomide DRUG

Oral

Also known as: Revlimid

Relapsed and/or refractory multiple myeloma

Dexamethasone DRUG

Oral or intravenous

Relapsed and/or refractory multiple myeloma

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Patients ≥ 19 years
• Relapsed and/or refractory multiple myeloma patients
• Patients who had received KRd combination chemotherapy from February, 2018 to February, 2020.

You may not qualify if:

• Patient who had not been treated with KRd combination therapy from the first cycle of treatment
• Patients who had received KRd combination chemotherapy before February, 2018 and after February, 2020.

Sponsors & Collaborators

• Dong-A University Hospital: lead
• Amgen: collaborator

Related Publications (1)

• 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.

  PMID: 25482145 BACKGROUND

MeSH Terms

Conditions

Multiple Myeloma

Interventions

carfilzomib; Lenalidomide; Dexamethasone

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Sung-Hyun Kim, MD, Ph.D

  Dong-A University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ji Hyun Lee, MD, Ph.D

CONTACT

82-51-240-2915; hidrleejh@dau.ac.kr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 5, 2022
• First Posted: August 10, 2022
• Study Start: August 1, 2022
• Primary Completion: January 31, 2023
• Study Completion: September 30, 2023
• Last Updated: August 10, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share