Clinical Trial Results:
LENALIDOMIDE MAINTENANCE IN MULTIPLE MYELOMA PATIENTS ACHIEVING AT LEAST VGPR AFTER INDUCTION THERAPY: MINIMAL RESIDUAL DISEASE MONITORING
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Summary
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EudraCT number |
2012-004063-52 |
Trial protocol |
IT |
Global end of trial date |
31 Aug 2017
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Results information
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Results version number |
v1(current) |
This version publication date |
21 Jan 2023
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First version publication date |
21 Jan 2023
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Other versions |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
RV-MM-PI-0694
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT03433365 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
FONDAZIONE EMN ITALY ONLUS
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Sponsor organisation address |
Via Saluzzo 1/A, Torino, Italy, 10125
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Public contact |
Data Center, Fondazione EMN Italy ONLUS, 011 0243236, clinicaltrialoffice@emn.org
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Scientific contact |
Data Center, Fondazione EMN Italy ONLUS, 011 0243236, clinicaltrialoffice@emn.org
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
02 Dec 2022
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
31 Aug 2017
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
1.To evaluate the activity of Lenalidomide on tumour load during maintenance phase analysing; 2.To verify whether molecular remissions obtained during maintenance therapy with Lenalidomide-based regimen are associated with a prolonged PFS.
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Protection of trial subjects |
Under approval of Local Etical Commitee
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
01 Dec 2012
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Italy: 73
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Worldwide total number of subjects |
73
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EEA total number of subjects |
73
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
73
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
- | ||||||
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Pre-assignment
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Screening details |
NA | ||||||
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Period 1
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Period 1 title |
Pre-maintenance (overall period)
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Is this the baseline period? |
Yes | ||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||
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Arms
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Arm title
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MRD analysis | ||||||
Arm description |
MRD analysis | ||||||
Arm type |
NOT APPLICABLE | ||||||
Investigational medicinal product name |
No intervention_Observational study
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Investigational medicinal product code |
O
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Other name |
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Pharmaceutical forms |
Capsule, hard
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Routes of administration |
Oral use
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Dosage and administration details |
No intervention_Observational 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.
To collect 2 samples for MRD analysis in patients treated with Lenalidomide
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Baseline characteristics reporting groups
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Reporting group title |
Pre-maintenance
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Reporting group description |
- | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Subject analysis sets
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Subject analysis set title |
Pre-maintenance
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Subject analysis set type |
Per protocol | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
The MRD population was defined as patients who had an available MRD sample before and/or after starting maintenance.
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End points reporting groups
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Reporting group title |
MRD analysis
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Reporting group description |
MRD analysis | ||
Subject analysis set title |
Pre-maintenance
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Subject analysis set type |
Per protocol | ||
Subject analysis set description |
The MRD population was defined as patients who had an available MRD sample before and/or after starting maintenance.
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End point title |
MRD conversion ASO-RQ-PCR [1] | ||||||||||||
End point description |
PFS analysis among patients with persistent MRD negativity and patients who turned to MRD positive by ASO-RQ-PCR
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End point type |
Primary
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End point timeframe |
40 months
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| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Statistical analysis and P value are not reported since the system give me an error that I'm not able to understand and fix. All p values are reported in the publication |
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End point title |
Progression Free Survival ASO-RQ-PCR | ||||||||||||
End point description |
PFS was calculated from the date of BM sampling before maintenance to the date of progression or death or the date the patient was last known to be in remission.
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End point type |
Secondary
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End point timeframe |
40 Months
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Progression Free Survival MFC | ||||||||||||
End point description |
PFS was calculated from the date of BM sampling before maintenance to the date of progression or death or the date the patient was last known to be in remission.
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End point type |
Secondary
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End point timeframe |
40 months
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Comparison of MFC and ASO-RQ-PCR Analyses | ||||||||
End point description |
The Pearson correlation coefficient (r) was used to compare methods of MRD analysis (ASORQ-PCR and MFC)
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End point type |
Secondary
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End point timeframe |
40 monts
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| No statistical analyses for this end point | |||||||||
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End point title |
Overall Survival ASO-RQ-PCR | ||||||||||||
End point description |
OS was calculated from the date of BM sampling before maintenance to the date of death or the date the patient was last known to be alive.
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End point type |
Secondary
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End point timeframe |
40 months
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Overall Survival MFC | ||||||||||||
End point description |
OS was calculated from the date of BM sampling before maintenance to the date of death or the date the patient was last known to be alive.
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End point type |
Secondary
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End point timeframe |
40 months
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| No statistical analyses for this end point | |||||||||||||
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End point title |
MRD conversion MFC | ||||||||||||
End point description |
PFS analysis among patients with persistent MRD negativity and patients who turned to MRD positive by MFC
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End point type |
Secondary
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End point timeframe |
40 monhts
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| No statistical analyses for this end point | |||||||||||||
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Adverse events information [1]
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Timeframe for reporting adverse events |
Not applicable for this study
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Adverse event reporting additional description |
Not applicable for this study.
Assessment type, Dictioanry are mandatory, but filled in only to save page. AE is not collected
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Assessment type |
Non-systematic | ||
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Dictionary used for adverse event reporting
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Dictionary name |
NO AE | ||
Dictionary version |
0
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| Frequency threshold for reporting non-serious adverse events: 5% | |||
| Notes [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported. Justification: AE is not collected and so analyzed for this study |
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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04 Apr 2017 |
- Updated Sponsor Name and Contact
- Added "study Commitees"
A steering committee that includes a subset of investigators in this study and representatives from Sponsor will be formed to provide advice on the conduct of the study and publications.”
- Added “If the serum and urine M-protein are unmeasurabled a > 90% decrease in the difference between involved and uninvolved FLC levels is required in place of the M-protein criteria.”
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Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
