Relapsed/Refractory Multiple MyelomaNCT06369935
A Real World Study of Equecabtagene Autoleucel in Subjects With Relapsed and Refractory Multiple Myeloma.
An observational study of Relapsed/Refractory Multiple Myeloma, run by Peking University People's Hospital at 1 site in China.
Trial summary
This study is a multicenter, observational, single-arm real world study. The purpose of this study is to describe demographic and disease characteristics, treatment patterns, and clinical outcomes in the real-world setting among participants in China with relapsed/refractory multiple myeloma (RRMM) who have been… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsed/Refractory Multiple Myeloma
- What is being tested?
- Equecabtagene Autoleucel
- How many people
- 260 participants
- Where
- 1 siteChina
- Study dates
- 20 Jun 2024to 20 Aug 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The target population of this study was adult patients with relapsed/refractory multiple myeloma who were treated in real world with equecabtagene autoleucel, a commercially available product.
Who may be able to join
- Adult patients with confirmed relapsed/refractory multiple myeloma;
- Based on clinical practice, the physician decided to administer equecabtagene autoleucel treatment;
- Voluntarily sign the informed consent form approved by the ethics committee.
Who cannot join
- Patients who are hypersensitive to the active ingredients of the product or any excipients (dimethyl sulfoxide, compound electrolyte injection, human albumin);
- The researcher believes that patients are unable to return for follow-up visits or that it is impossible to complete the study;
- Patients with expected survival less than 3 months
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Jin Lu contact
China1 site
Peking University People's Hospital
Beijing
Yang Liu, +8613716926210, pkuphliuyang@bjmu.edu.cn
About this study
This study is a multicenter, observational, single-arm real world study. The purpose of this study is to describe demographic and disease characteristics, treatment patterns, and clinical outcomes in the real-world setting among participants in China with relapsed/refractory multiple myeloma (RRMM) who have been treated with Equecabtagene Autoleucel. This study will use both prospective and retrospective data
Read the detailed description
Primary endpoint:
Best Overall Response Rate (BOR): The proportion of patients who receive treatment with Ikeolensay injection and have been evaluated by researchers as having the best disease status is strict complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR).
Secondary endpoint:
Progress Free Survival (PFS) rate at 6 months: The probability of patients not experiencing disease progression or death from any cause after receiving treatment with Ikeolensay injection for 6 months; Overall survival (OS) rate at 6 months: the probability of survival of patients after receiving treatment with Ikeolensay injection for 6 months; Time to Response (TTR): The time interval between the patient receiving treatment with Ikeolensay injection and the first recorded time of disease remission; Time to Complete Response (TTCR): The time interval between the patient receiving treatment with Ikeolensay injection and the first recording of complete disease response (CR or sCR); Adverse Event (AE): After receiving treatment with Ikeolensay Injection, researchers consider all adverse events and serious adverse events (SAE) related to Ikeolensay Injection treatment; Hospitalization: After receiving treatment with Ikeolensay injection, the researcher considers any hospitalization related to Ikeolensay injection treatment (including the reason, duration, and outcome of hospitalization); Death: The death of the patient after receiving treatment with Ikeolensay injection, recording the date and cause of death (any reason); Secondary malignant tumors: For any secondary malignant tumors discovered during the monitoring process, researchers can obtain tumor biopsy samples and other necessary samples of tumor tissue according to clinical needs, relevant guiding principles, and product instructions for safety analysis; Quality of life: Evaluate the quality of life using the EQ-5D and EORTCQLQ C30 scoring standards; Medical resource utilization: Collect any medical resource utilization information related to the treatment of patients with Ikeolensay injection (including hospitalization, emergency, outpatient, and new prescription drug usage).
- Conditions
- Relapsed/Refractory Multiple Myeloma
- Being tested
- Equecabtagene Autoleucel
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Equecabtagene AutoleucelDrug
Also called CT103A
Equecabtagene Autoleucel (CT103A) is a novel fully human BCMA-targeting CAR-T therapy
What is being measured
The primary outcome is the main question the study is designed to answer.
Best Overall Response Rate， BOR
Patients treatmented with Equecabtagene Autoleucel, the optimal disease state evaluated by the researcher is strict complete response (sCR),complete response (CR), very good partial response (Very Good Partial Response (VGPR) or partial response (partial response,PR) rate.
Measured: up to 24 weeks
Secondary outcomes (5)
PFS rate of 6 month
Probability of patients not experiencing disease progression or death from any cause 6 months after starting treatment with equecabtagene autoleucel
Measured: up to 24 weeks
OS rate of 6 month
Probability of patient survival 6 months after equecabtagene autoleucel treatment
Measured: up to 24 weeks
Time to Response， TTR
From the time the patient received equecabtagene autoleucel to the first recorded remission of the disease
Measured: up to 24 weeks
Time to Complete Response， TTCR
From the time the patient received equecabtagene autoleucel to the first recorded complete remission of the disease (time interval between CR or sCR)
Measured: up to 24 weeks
Adverse Event， AE
After the patient received treatment with equecabtagene autoleucel, the investigators considered all adverse events and serious adverse events (SAE) related to the treatment with Equecabtagene Autoleucel.
Measured: up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2024
- Study start20 Jun 2024 (estimated)
- Primary completion20 Aug 2026 (estimated)
- Study completion20 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed/Refractory Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin Lu, MD, Peking University People's Hospital
- Investigators
- Jin Lu, Principal investigator, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06369935
- Sponsor's protocol ID
- 20240407
- Status last verified
- Apr 2024
- First submitted
- 11 Apr 2024
- Last updated
- 17 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Real World Study of Equecabtagene Autoleucel in Subjects With Relapsed and Refractory Multiple Myeloma.
- ClinicalTrials.gov ID
- NCT06369935
- Acronym / sponsor ID
- 20240407
- Conditions
- Relapsed/Refractory Multiple Myeloma
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 20 Jun 2024 (estimated)
- Primary completion
- 20 Aug 2026 (estimated)
- Study completion
- 20 Aug 2027 (estimated)
- First posted
- 17 Apr 2024 (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.
This study is a multicenter, observational, single-arm real world study. The purpose of this study is to describe demographic and disease characteristics, treatment patterns, and clinical outcomes in the real-world setting among participants in China with relapsed/refractory multiple myeloma (RRMM) who have been treated with Equecabtagene Autoleucel. This study will use both prospective and retrospective data
Detailed description
Primary endpoint:
Best Overall Response Rate (BOR): The proportion of patients who receive treatment with Ikeolensay injection and have been evaluated by researchers as having the best disease status is strict complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR).
Secondary endpoint:
Progress Free Survival (PFS) rate at 6 months: The probability of patients not experiencing disease progression or death from any cause after receiving treatment with Ikeolensay injection for 6 months; Overall survival (OS) rate at 6 months: the probability of survival of patients after receiving treatment with Ikeolensay injection for 6 months; Time to Response (TTR): The time interval between the patient receiving treatment with Ikeolensay injection and the first recorded time of disease remission; Time to Complete Response (TTCR): The time interval between the patient receiving treatment with Ikeolensay injection and the first recording of complete disease response (CR or sCR); Adverse Event (AE): After receiving treatment with Ikeolensay Injection, researchers consider all adverse events and serious adverse events (SAE) related to Ikeolensay Injection treatment; Hospitalization: After receiving treatment with Ikeolensay injection, the researcher considers any hospitalization related to Ikeolensay injection treatment (including the reason, duration, and outcome of hospitalization); Death: The death of the patient after receiving treatment with Ikeolensay injection, recording the date and cause of death (any reason); Secondary malignant tumors: For any secondary malignant tumors discovered during the monitoring process, researchers can obtain tumor biopsy samples and other necessary samples of tumor tissue according to clinical needs, relevant guiding principles, and product instructions for safety analysis; Quality of life: Evaluate the quality of life using the EQ-5D and EORTCQLQ C30 scoring standards; Medical resource utilization: Collect any medical resource utilization information related to the treatment of patients with Ikeolensay injection (including hospitalization, emergency, outpatient, and new prescription drug usage).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The target population of this study was adult patients with relapsed/refractory multiple myeloma who were treated in real world with equecabtagene autoleucel, a commercially available product.
Key inclusion criteria (3 listed)
- Adult patients with confirmed relapsed/refractory multiple myeloma;
- Based on clinical practice, the physician decided to administer equecabtagene autoleucel treatment;
- Voluntarily sign the informed consent form approved by the ethics committee.
Key exclusion criteria (3 listed)
- Patients who are hypersensitive to the active ingredients of the product or any excipients (dimethyl sulfoxide, compound electrolyte injection, human albumin);
- The researcher believes that patients are unable to return for follow-up visits or that it is impossible to complete the study;
- Patients with expected survival less than 3 months
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 |
|---|---|---|
| Equecabtagene AutoleucelAlso: CT103AEquecabtagene Autoleucel (CT103A) is a novel fully human BCMA-targeting CAR-T therapy | Drug | – |
Primary outcome
Best Overall Response Rate， BOR
Time frame: up to 24 weeks
Patients treatmented with Equecabtagene Autoleucel, the optimal disease state evaluated by the researcher is strict complete response (sCR),complete response (CR), very good partial response (Very Good Partial Response (VGPR) or partial response (partial response,PR) rate.
5 secondary outcomes
PFS rate of 6 month
Time frame: up to 24 weeks
OS rate of 6 month
Time frame: up to 24 weeks
Time to Response， TTR
Time frame: up to 24 weeks
Time to Complete Response， TTCR
Time frame: up to 24 weeks
Adverse Event， AE
Time frame: up to 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2024.
- Individual participant dataSharing planned: No
Related trials for Relapsed/Refractory Multiple Myeloma
Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 3
A Trial to Learn How Well Linvoseltamab Works Compared to the Combination of Elotuzumab, Pomalidomide and Dexamethasone for Adult Participants With Relapsed/Refractory Multiple Myeloma
Relapsed Refractory Multiple Myeloma (RRMM)
RecruitingPhase 1/2
A Trial to Study if REGN17372 in Combination With Linvoseltamab is Tolerable for Adult Participants With Relapsed/Refractory Multiple Myeloma
Relapsed Refractory Multiple Myeloma (RRMM)
RecruitingPhase 1
A Study to Examine the Effects of Novel Therapy Linvoseltamab in Combination With Other Cancer Treatments for Adult Participants With Multiple Myeloma That is Resistant to Current Standard of Care Treatments
Multiple Myeloma
RecruitingPhase 1
A Study Evaluating the Safety, Pharmacokinetics, and Activity of the Combination of Cevostamab and Elranatamab in Participants With Relapsed or Refractory Multiple Myeloma (R/R MM)
Relapsed or Refractory Multiple Myeloma
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.
Jin Lu contact
Jin Lu principal investigator
Peking University People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Relapsed/Refractory Multiple Myeloma, run by Peking University People's Hospital at 1 site in China.
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 3 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: opening soon, as of the sponsor's last update on 17 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yang Liu, Doctor (+8613716926210, pkuphliuyang@bjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Best Overall Response Rate， BOR (time frame: up to 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Apr 2024.