Multiple MyelomaMRD-CONFIRMNCT05203003
Prospective Evaluation of the Prognostic Impact of Measurable Residual Disease (MRD) Within a Phase III Study Comparing a Fixed Duration Therapy Versus Continuous Therapy With Daratumumab, Lenalidomide, and Dexamethasone for Relapsed Multiple Myeloma Requiring a First Salvage Treatment.
An observational study of Multiple Myeloma, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
We propose to conduct an ancillary prospective evaluation of the impact of Dara-Len-Dex discontinuation after 2 years, on the persistence of MRD negativity in patients that were MRD negative at 2 years. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Assessment of MRD
- How many people
- 260 participants
- Where
- 1 siteFrance
- Study dates
- 22 Apr 2022to Dec 2028
- 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: Adult patients who are included in the CONFIRM phase III trial
Who may be able to join
- Adult patients (≥ 18 years old) who are included in the CONFIRM phase III trial (ClinicalTrials.gov Identifier: NCT03836014).
- Subject that are still under therapy at 2 years (+/- 3 month) after randomization, either in the fixed duration therapy group or in the continuous therapy group of the CONFIRM protocol
- Subject in complete response at 2 years (+/- 3 month) after randomization.
- Signed informed consent
- Affiliation to a social security system or equivalent
Who cannot join
- None
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Department of Hematology, Hospital Saint Antoine
Paris, 75012
Mohamad MOHTY, PU-PH, + 33 149 28 26 20, mohamad.mohty@inserm.fr
Florent MALARD, MD, +33 149 28 09 68, malardf@yahoo.fr
About this study
We propose to conduct an ancillary prospective evaluation of the impact of Dara-Len-Dex discontinuation after 2 years, on the persistence of MRD negativity in patients that were MRD negative at 2 years.
- Conditions
- Multiple Myeloma
- Being tested
- Assessment of MRD
- Keywords
- multiple myeloma, measurable residual disease, daratumumab, lenalidomide, dexamethasone
- Medical subject headings
- Multiple Myeloma, Neoplasm, Residual
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment of MRDOther
Bone marrow aspirate for assessment of MRD will be performed at 2 years (+/- 3 month) after randomization in patients still under treatment and in complete response.
Thereafter, bone marrow aspirate for assessment of MRD will be repeated at 3 and 4 years in patients that maintain complete response, irrespective of the randomization arm and therefore of treatment administration.
| Study group | Role | What they receive |
|---|---|---|
| Adult patients who are included in the CONFIRM phase III trial | Not described Receives: Other: Assessment of MRD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of patients that maintain MRD negativity
Rate of patients that maintain MRD negativity at 3 and 4 years after inclusion in the current protocol in the continuous Dara-Len-Dex therapy group versus fixed duration Dara-Len-Dex therapy (2 years) group.
Measured: 3 and 4 years after inclusion
Secondary outcomes (1)
PFS at 2 years
PFS at 2 years after initial assessment of MRD negativity, which is defined as the duration from the date of MRD measurement to either progressive disease, according to the IMWG criteria, or death.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2022
- Study start22 Apr 2022
- Primary completionApr 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mohamad MOHTY, PUPH, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05203003
- Sponsor's protocol ID
- APHP210482
- Acronym
- MRD-CONFIRM
- Status last verified
- Dec 2024
- First submitted
- 10 Jan 2022
- Last updated
- 6 Dec 2024
- Results posted
- No
- Data monitoring committee
- 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 6 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of the Prognostic Impact of Measurable Residual Disease (MRD) Within a Phase III Study Comparing a Fixed Duration Therapy Versus Continuous Therapy With Daratumumab, Lenalidomide, and Dexamethasone for Relapsed Multiple Myeloma Requiring a First Salvage Treatment.
- ClinicalTrials.gov ID
- NCT05203003
- Acronym / sponsor ID
- MRD-CONFIRM / APHP210482
- Conditions
- Multiple Myeloma
- Keywords
- multiple myeloma, measurable residual disease, daratumumab, lenalidomide, dexamethasone
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 22 Apr 2022 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 24 Jan 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.
We propose to conduct an ancillary prospective evaluation of the impact of Dara-Len-Dex discontinuation after 2 years, on the persistence of MRD negativity in patients that were MRD negative at 2 years.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult patients who are included in the CONFIRM phase III trial | – | Other: Assessment of MRD |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients who are included in the CONFIRM phase III trial
Key inclusion criteria (5 listed)
- Adult patients (≥ 18 years old) who are included in the CONFIRM phase III trial (ClinicalTrials.gov Identifier: NCT03836014).
- Subject that are still under therapy at 2 years (+/- 3 month) after randomization, either in the fixed duration therapy group or in the continuous therapy group of the CONFIRM protocol
- Subject in complete response at 2 years (+/- 3 month) after randomization.
- Signed informed consent
- Affiliation to a social security system or equivalent
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Assessment of MRDBone marrow aspirate for assessment of MRD will be performed at 2 years (+/- 3 month) after randomization in patients still under treatment and in complete response. Thereafter, bone marrow aspirate for assessment of MRD will be repeated at 3 and 4 years in patients that maintain complete response, irrespective of the randomization arm and therefore of treatment administration. | Other | Adult patients who are included in the CONFIRM phase III trial |
Primary outcome
Rate of patients that maintain MRD negativity
Time frame: 3 and 4 years after inclusion
Rate of patients that maintain MRD negativity at 3 and 4 years after inclusion in the current protocol in the continuous Dara-Len-Dex therapy group versus fixed duration Dara-Len-Dex therapy (2 years) group.
1 secondary outcome
PFS at 2 years
Time frame: 2 years
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 6 Dec 2024.
- 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.
Mohamad MOHTY, PUPH principal investigator
Assistance Publique - Hôpitaux de Paris
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 Multiple Myeloma, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 5 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 6 Dec 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 France. 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 Mohamad MOHTY, PUPH (+ 33 149 28 26 20, mohamad.mohty@inserm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of patients that maintain MRD negativity (time frame: 3 and 4 years after inclusion). 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 6 Dec 2024.