Multiple MyelomaNCT06541860
DAratumumab and REvlimid REfractory MM
An observational study of Multiple Myeloma, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.
Trial summary
Retrospective and prospective multicenter observational study on patients with relapsed and refractory multiple myeloma after anti-CD38 MoAb therapy and IMIDS treated with onlabel regimens. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 21 Aug 2023to 21 Aug 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: Patients with relapsed and refractory multiple myeloma after anti-CD38 MoAb therapy and IMIDS treated with onlabel regimens.
Who may be able to join
- Phase I
- Patients with RRMM after therapy with anti-CD38 MoAb plus IMIDS started on therapy with PVD scheme
- Patients aged ≥ 18 years
- Patients able to understand and voluntarily sign an informed consent and be willing to consent to the review of clinical data
- Phase II
- Patients with RRMM after first-line therapy with anti-CD38 MoAb plus IMIDS started on therapy with on-label schemes
- Patients aged ≥ 18 years
- Patients able to understand and voluntarily sign an informed consent and be willing to consent to the review of clinical data
Who cannot join
- Patients not willing to consent to review of clinical data
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Irccs San Matteo Pavia
Pavia, PV, 27100
Alessandra Ferrari, 0382.503689, alessandra.ferrari@smatteo.pv.it
Silvia Mangiacavalli
About this study
Official title: Salvage Regimens in Multiple Myeloma Patients Double Refractory to Lenalidomide and MoAbs: Evidence From Real World Experience
Retrospective and prospective multicenter observational study on patients with relapsed and refractory multiple myeloma after anti-CD38 MoAb therapy and IMIDS treated with onlabel regimens.
- Conditions
- Multiple Myeloma
- Medical subject headings
- Multiple Myeloma
What is being measured
The primary outcome is the main question the study is designed to answer.
To explore the efficacy and tolerability of different combinations, particularly the PVD regimen, in the emerging context of RRMM after anti-CD38 MoAb plus IMIDS therapy.
Phase I - Retrospective study The primary objective is to estimate 2-year progression-free survival (PFS) of PVd when used in RRMM after anti-CD38 MoAb and IMIDS
Phase II - Prospective study The primary objective is to estimate the 2-year progression-free survival (PFS) of the on-label combinations in patients with relapsed RRMM after first-line therapy with anti-CD38 MoAb plus IMIDS
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 posted7 Aug 2024
- Study start21 Aug 2023
- Primary completion21 Feb 2028 (estimated)
- Study completion21 Aug 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.
- 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
- Other
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06541860
- Sponsor's protocol ID
- DARE-MM
- Status last verified
- Aug 2024
- First submitted
- 9 Apr 2024
- Last updated
- 7 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Salvage Regimens in Multiple Myeloma Patients Double Refractory to Lenalidomide and MoAbs: Evidence From Real World Experience
- ClinicalTrials.gov ID
- NCT06541860
- Acronym / sponsor ID
- DARE-MM
- Conditions
- Multiple Myeloma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di PaviaUniversity, hospital or other
- Study start
- 21 Aug 2023 (actual)
- Primary completion
- 21 Feb 2028 (estimated)
- Study completion
- 21 Aug 2028 (estimated)
- First posted
- 7 Aug 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.
Retrospective and prospective multicenter observational study on patients with relapsed and refractory multiple myeloma after anti-CD38 MoAb therapy and IMIDS treated with onlabel regimens.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with relapsed and refractory multiple myeloma after anti-CD38 MoAb therapy and IMIDS treated with onlabel regimens.
Key inclusion criteria (8 listed)
- Phase I
- Patients with RRMM after therapy with anti-CD38 MoAb plus IMIDS started on therapy with PVD scheme
- Patients aged ≥ 18 years
- Patients able to understand and voluntarily sign an informed consent and be willing to consent to the review of clinical data
- Phase II
Key exclusion criteria (1 listed)
- Patients not willing to consent to review of clinical data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To explore the efficacy and tolerability of different combinations, particularly the PVD regimen, in the emerging context of RRMM after anti-CD38 MoAb plus IMIDS therapy.
Time frame: 2 years
Phase I - Retrospective study The primary objective is to estimate 2-year progression-free survival (PFS) of PVd when used in RRMM after anti-CD38 MoAb and IMIDS Phase II - Prospective study The primary objective is to estimate the 2-year progression-free survival (PFS) of the on-label combinations in patients with relapsed RRMM after first-line therapy with anti-CD38 MoAb plus IMIDS
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 7 Aug 2024.
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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.
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 Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.
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 8 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 7 Aug 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 Italy. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To explore the efficacy and tolerability of different combinations, particularly the PVD regimen, in the emerging context of RRMM after anti-CD38 MoAb plus IMIDS therapy. (time frame: 2 years). 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 7 Aug 2024.