Multiple MyelomaMRDNCT03433365
Monitoring of Deep of Response During Lenalidomide Maintenance in MM Patients Achieving at Least Very Good Partial Response (MRD)
An observational study of Multiple Myeloma, run by Fondazione EMN Italy Onlus at 1 site in Italy.
Trial summary
This is an italian multicenter study to determine whether maintenance treatment with Lenalidomide-based regimen significantly increases the rate of molecular remission in patients achieving at least a VGPR after therapy with new drugs combination. 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?
- MRD analysis
- How many people
- 70 participants
- Where
- 1 siteItaly
- Study dates
- Mar 2013to Aug 2017
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Potential study subjects will sign an informed consent prior undergoing any study related procedure. Patients enrolled in this study will receive Lenalidomide-based regimen as maintenance therapy according to their previous decided therapeutic schedule.
Who may be able to join
- Patient is, in the investigator(s) opinion, willing and able to comply with the protocol requirements.
- Patient has given voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care.
- Patient has achieved at least a Very Good Partial Response (VGPR) before starting maintenance therapy
- Availability of a bone marrow sample at diagnosis stored in the Institution tissue bank to create patient-specific probes derived from IgH rearrangement
- Patients must receive Lenalidomide-based regimen as maintenance after a first line therapeutic approach
- Patient is 18 years old at the time of signing the informed consent
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- Patient has a Karnofsky performance status ≥ 60%.
- Patient has a life-expectancy > 6 months
- Patient has HBV, HCV and HIV negative test.
- Patients must have normal ECG and NYHA ≤ 2; an evaluation of ejection fraction by ECHO or MUGA is optional
- Patients must be informed on acute and late toxicity of Lenalidomide treatment and must sign an informed consent.
Who cannot join
- Any serious medical condition, including the presence of laboratory abnormalities, which places the subject at an unacceptable risk if he or she participates in this study or confounds the experimental ability to interpret data from the study.
- Achieving of a PR or less before starting maintenance therapy
- Pregnant or lactating women. A serum β-hCG pregnancy test must be performed at the Screening visit, for female patients of child-bearing potential. If the test is positive, the patient must be excluded from the study. Confirmation that the patient is not pregnant must be established by a negative serum or urinary pregnancy test with the result obtained 1 day prior to the Baseline visit (or the day of the visit if results are available before drug delivery). A pregnancy test is not required for naturally post-menopausal women (who have not had menses at any time in the preceding 24 consecutive months) or surgically sterilised women (hysterectomy, bilateral ovariectomy, bilateral salpingectomy).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Lenalidomide Maintenance in Multiple Myeloma Patients Achieving at Least VGPR After Induction Therapy: Minimal Residual Disease Monitoring
This is an italian multicenter study to determine whether maintenance treatment with Lenalidomide-based regimen significantly increases the rate of molecular remission in patients achieving at least a VGPR after therapy with new drugs combination. No changing in the planned therapy will be made according to MRD results. A total of 70 patients with newly diagnosed MM who are 18 years of age or older and who meet all of the eligibility criteria may be enrolled in this study.
Potential study subjects will sign an informed consent prior undergoing any study related procedure. Patients enrolled in this study will receive Lenalidomide-based regimen as maintenance therapy according to their previous decided therapeutic schedule. All consecutive patients treated with Lenalidomide-based regimen as maintenance therapy and with inclusion criteria will be asked to participate to this study.
No additional drugs will be administrated for this study whose aim is to monitor the MRD on bone marrow aspirate and peripheral blood of patients during maintenance therapy with Lenalidomide-based regimen.
Read the detailed description
Patients entering the study will signed an informed consent and will undergo bone marrow aspiration and peripheral blood examination. On both these two tissues the MRD analysis reaching for myeloma cells.
During the treatment period, all patients will attend study center visits every 4 weeks, until development of confirmed Progressive Disease (PD). During this visits the patients will undergo physical evaluation and routine blood control will be performed to monitor response to therapy and side effects.
When a patient develops a PD requiring the beginning of a new treatment, the patient interrupts the MRD monitoring but will be followed for survival every 2 months via telephone or office visit.
- Conditions
- Multiple Myeloma
- Being tested
- MRD analysis
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRD analysisOther
Also called No intervention_Observational study
To collect 2 samples for MRD analysis in patients treated with Lenalidomide
| Study group | Role | What they receive |
|---|---|---|
| 1 | Potential study subjects will sign an informed consent prior undergoing any study related procedure. Patients enrolled in this study will receive Lenalidomide-based regimen as maintenance therapy according to their previous decided therapeutic schedule. All consecutive patients treated with Lenalidomide-based regimen as maintenance therapy and with inclusion criteria will be asked to participate to this study. Receives: Other: MRD analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
MRD conversion
Rate of conversion from MRD positive to MRD negative during maintenance therapy (qualitative PCR approach)
Measured: 2 years
Tumour load
Rate of patients with a reducing or increasing tumour load during therapy (quantitative real time PCR approach)
Measured: 2 years
Molecular relapse
Rate of molecular relapse
Measured: 2 years
Secondary outcomes (4)
MRD negativity
MRD negativity duration during lenalidomide maintenance treatment
Measured: 2 years
Molecular relapse
Time from diagnosis to molecular relapse. Evaluate if molecular relapse can be considered an early biomarker of relapse
Measured: 2 years
Peripheral blood compared with bone marrow
Evaluate MRD negativity on peripheral blood samples and compare it with MRD analysis conducted on bone marrow samples
Measured: 2 years
Overall Survival
Time from diagnosis to death in patients who achieved a molecular remission. Compare these results with the overall population
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 posted14 Feb 2018
- Study startMar 2013
- Primary completionMar 2016
- Study completionAug 2017
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
- Other
- Time perspective
- Prospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione EMN Italy Onlus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03433365
- Sponsor's protocol ID
- RV-MM-PI-0694
- Acronym
- MRD
- Status last verified
- Nov 2018
- First submitted
- 8 Feb 2018
- Last updated
- 6 Nov 2018
- 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 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lenalidomide Maintenance in Multiple Myeloma Patients Achieving at Least VGPR After Induction Therapy: Minimal Residual Disease Monitoring
- ClinicalTrials.gov ID
- NCT03433365
- Acronym / sponsor ID
- MRD / RV-MM-PI-0694
- Conditions
- Multiple Myeloma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Fondazione EMN Italy OnlusUniversity, hospital or other
- Study start
- Mar 2013 (actual)
- Primary completion
- Mar 2016 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 14 Feb 2018 (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 is an italian multicenter study to determine whether maintenance treatment with Lenalidomide-based regimen significantly increases the rate of molecular remission in patients achieving at least a VGPR after therapy with new drugs combination. No changing in the planned therapy will be made according to MRD results. A total of 70 patients with newly diagnosed MM who are 18 years of age or older and who meet all of the eligibility criteria may be enrolled in this study.
Potential study subjects will sign an informed consent prior undergoing any study related procedure. Patients enrolled in this study will receive Lenalidomide-based regimen as maintenance therapy according to their previous decided therapeutic schedule. All consecutive patients treated with Lenalidomide-based regimen as maintenance therapy and with inclusion criteria will be asked to participate to this study.
No additional drugs will be administrated for this study whose aim is to monitor the MRD on bone marrow aspirate and peripheral blood of patients during maintenance therapy with Lenalidomide-based regimen.
Detailed description
Patients entering the study will signed an informed consent and will undergo bone marrow aspiration and peripheral blood examination. On both these two tissues the MRD analysis reaching for myeloma cells.
During the treatment period, all patients will attend study center visits every 4 weeks, until development of confirmed Progressive Disease (PD). During this visits the patients will undergo physical evaluation and routine blood control will be performed to monitor response to therapy and side effects.
When a patient develops a PD requiring the beginning of a new treatment, the patient interrupts the MRD monitoring but will be followed for survival every 2 months via telephone or office visit.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Other: MRD analysisPotential study subjects will sign an informed consent prior undergoing any study related procedure. Patients enrolled in this study will receive Lenalidomide-based regimen as maintenance therapy according to their previous decided therapeutic schedule. All consecutive patients treated with Lenalidomide-based regimen as maintenance therapy and with inclusion criteria will be asked to participate to this study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Potential study subjects will sign an informed consent prior undergoing any study related procedure. Patients enrolled in this study will receive Lenalidomide-based regimen as maintenance therapy according to their previous decided therapeutic schedule.
Key inclusion criteria (11 listed)
- Patient is, in the investigator(s) opinion, willing and able to comply with the protocol requirements.
- Patient has given voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care.
- Patient has achieved at least a Very Good Partial Response (VGPR) before starting maintenance therapy
- Availability of a bone marrow sample at diagnosis stored in the Institution tissue bank to create patient-specific probes derived from IgH rearrangement
- Patients must receive Lenalidomide-based regimen as maintenance after a first line therapeutic approach
Key exclusion criteria (3 listed)
- Any serious medical condition, including the presence of laboratory abnormalities, which places the subject at an unacceptable risk if he or she participates in this study or confounds the experimental ability to interpret data from the study.
- Achieving of a PR or less before starting maintenance therapy
- Pregnant or lactating women. A serum β-hCG pregnancy test must be performed at the Screening visit, for female patients of child-bearing potential. If the test is positive, the patient must be excluded from the study. Confirmation that the patient is not pregnant must be established by a negative serum or urinary pregnancy test with the result obtained 1 day prior to the Baseline visit (or the day of the visit if results are available before drug delivery). A pregnancy test is not required for naturally post-menopausal women (who have not had menses at any time in the preceding 24 consecutive months) or surgically sterilised women (hysterectomy, bilateral ovariectomy, bilateral salpingectomy).
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 |
|---|---|---|
| MRD analysisAlso: No intervention_Observational studyTo collect 2 samples for MRD analysis in patients treated with Lenalidomide | Other | 1 |
Primary outcome
MRD conversion
Time frame: 2 years
Rate of conversion from MRD positive to MRD negative during maintenance therapy (qualitative PCR approach)
Tumour load
Time frame: 2 years
Rate of patients with a reducing or increasing tumour load during therapy (quantitative real time PCR approach)
Molecular relapse
Time frame: 2 years
Rate of molecular relapse
4 secondary outcomes
MRD negativity
Time frame: 2 years
Molecular relapse
Time frame: 2 years
Peripheral blood compared with bone marrow
Time frame: 2 years
Overall Survival
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2018.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 EMN Italy Onlus 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 11 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: finished, as of the sponsor's last update on 6 Nov 2018. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MRD conversion (time frame: 2 years). The study lists 3 primary outcomes in all. 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 Nov 2018.