Multiple Myeloma in RelapseNCT05495620
Long-term KRd in Relapsed and/or Refractory Multiple Myeloma
An observational study of Multiple Myeloma in Relapse and Multiple Myeloma, Refractory, run by Dong-A University Hospital.
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… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Multiple Myeloma in Relapse, Multiple Myeloma, Refractory
- What is being tested?
- Carfilzomib, Lenalidomide and Dexamethasone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2022to 30 Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Relapsed and/or refractory multiple myeloma patients treated with carfilzomib-lenalidomide-dexamethasone combination chemotherapy
Who may be able to join
- Patients ≥ 19 years
- Relapsed and/or refractory multiple myeloma patients
- Patients who had received KRd combination chemotherapy from February, 2018 to February, 2020.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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
Read the 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
- Being tested
- Carfilzomib, Lenalidomide, Dexamethasone
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CarfilzomibDrug
Also called Kyprolis
Intravenous
carfilzomib, lenalidomide, dexamethasone
LenalidomideDrug
Also called Revlimid
Oral
DexamethasoneDrug
Oral or intravenous
| Study group | Role | What they receive |
|---|---|---|
| Relapsed and/or refractory multiple myeloma | Multiple myeloma in relapsed but not refractory, relapsed and refractory, and primary refractory status Receives: Drug: Carfilzomib; Drug: Lenalidomide; Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
the time from the first date of KRd to the date of disease progression or death or censored date
Measured: up to 54 months
Secondary outcomes (4)
Overall survival
the time from the first date of KRd treatment to the time of death or censored date
Measured: 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
Measured: 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
Measured: 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
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2022
- Study start1 Aug 2022 (estimated)
- Primary completion31 Jan 2023 (estimated)
- Study completion30 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple Myeloma in RelapseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dong-A University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Amgen
- Responsible party
- Principal investigator, Sung-Hyun Kim, Dong-A University Hospital
- Investigators
- Sung-Hyun Kim, MD, Ph.D, Principal investigator, Dong-A University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05495620
- Sponsor's protocol ID
- DAUHIRB-22-081
- Status last verified
- Aug 2022
- First submitted
- 5 Jul 2022
- Last updated
- 10 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 25482145
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-world Evidence of Carfilzomib, Lenalidomide, Dexamethasone Combination Therapy in Korean Relapsed and/or Refractory Multiple Myeloma Patients
- ClinicalTrials.gov ID
- NCT05495620
- Acronym / sponsor ID
- DAUHIRB-22-081
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Dong-A University HospitalUniversity, hospital or other
- Collaborators
- Amgen
- Study start
- 1 Aug 2022 (estimated)
- Primary completion
- 31 Jan 2023 (estimated)
- Study completion
- 30 Sep 2023 (estimated)
- First posted
- 10 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Relapsed and/or refractory multiple myeloma | – | Drug: Carfilzomib, Drug: Lenalidomide, Drug: DexamethasoneMultiple myeloma in relapsed but not refractory, relapsed and refractory, and primary refractory status |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Relapsed and/or refractory multiple myeloma patients treated with carfilzomib-lenalidomide-dexamethasone combination chemotherapy
Key inclusion criteria (3 listed)
- Patients ≥ 19 years
- Relapsed and/or refractory multiple myeloma patients
- Patients who had received KRd combination chemotherapy from February, 2018 to February, 2020.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CarfilzomibAlso: KyprolisIntravenous carfilzomib, lenalidomide, dexamethasone | Drug | Relapsed and/or refractory multiple myeloma |
| LenalidomideAlso: RevlimidOral | Drug | Relapsed and/or refractory multiple myeloma |
| DexamethasoneOral or intravenous | Drug | Relapsed and/or refractory multiple myeloma |
Primary outcome
Progression-free survival
Time frame: up to 54 months
the time from the first date of KRd to the date of disease progression or death or censored date
4 secondary outcomes
Overall survival
Time frame: up to 54 months
Overall response rate, clinical benefit rate
Time frame: up to 54 months
Duration of response
Time frame: up to 54 months
Toxicity profile
Time frame: up to 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2022.
- Background: PubMed 25482145Stewart 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sung-Hyun Kim, MD, Ph.D principal investigator
Dong-A University Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Myeloma in Relapse and Multiple Myeloma, Refractory, run by Dong-A University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ji Hyun Lee, MD, Ph.D (82-51-240-2915, hidrleejh@dau.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (time frame: up to 54 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05495620, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2022.