Clinical Trial Results:
Carfilzomib and lenalidomide-based treatment for younger and elderly newly diagnosed primary plasma cell leukemia patients
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Summary
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EudraCT number |
2013-005157-75 |
Trial protocol |
NL BE NO DK GB IT |
Global end of trial date |
30 Jan 2025
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Results information
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Results version number |
v1(current) |
This version publication date |
23 Oct 2025
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First version publication date |
23 Oct 2025
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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 |
EMN12/HOVON_129_PCL
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Additional study identifiers
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ISRCTN number |
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US NCT number |
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WHO universal trial number (UTN) |
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Sponsors
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Sponsor organisation name |
HOVON
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Sponsor organisation address |
Dr. Molewaterplein 40, Rotterdam, Netherlands, 3015GD
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Public contact |
HOVON Data Center, HOVON, +31 0107041560, hdc@erasmusmc.nl
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Scientific contact |
HOVON Data Center, HOVON, +31 0107041560, hdc@erasmusmc.nl
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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 |
23 Jun 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 |
30 Jan 2025
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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 |
To evaluate progression-free survival in adult pPCL patients by incorporation of carfilzomib and lenalidomide in induction, consolidation, and maintenance therapy
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Protection of trial subjects |
Monitoring and Insurance
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Background therapy |
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Evidence for comparator |
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Actual start date of recruitment |
01 Oct 2014
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
Yes
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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 |
Netherlands: 33
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Country: Number of subjects enrolled |
Norway: 3
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Country: Number of subjects enrolled |
United Kingdom: 2
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Country: Number of subjects enrolled |
Belgium: 5
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Country: Number of subjects enrolled |
Czechia: 2
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Country: Number of subjects enrolled |
Denmark: 7
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Country: Number of subjects enrolled |
Italy: 9
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Worldwide total number of subjects |
61
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EEA total number of subjects |
59
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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) |
32
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From 65 to 84 years |
29
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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 |
All subjects gave written informed consent and were screened according to the inclusion- and exclusion criteria | ||||||||||||||||
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Period 1
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Period 1 title |
Overall period
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Is this the baseline period? |
Yes | ||||||||||||||||
Allocation method |
Non-randomised - controlled
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Blinding used |
Not blinded | ||||||||||||||||
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Arms
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Arm title
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Experimental | ||||||||||||||||
Arm description |
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Arm type |
Experimental | ||||||||||||||||
Investigational medicinal product name |
lenalidomide
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Investigational medicinal product code |
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Other name |
REVLIMID®
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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 |
The recommended starting dose of lenalidomide is 25 mg/day PO on Days 1 to 21 of repeated 28-day cycles for RRMM. The recommended dose of dexamethasone is 40 mg/day PO on Days 1 to 4, 9 to 12, and 17 to 20 of each 28-day cycle for the first 4 cycles of therapy and then 40 mg/day PO on Days 1 to 4 every 28 days.
The recommended starting dose of lenalidomide is 25 mg PO QD on Days 1 to 21 of repeated 28-day cycles for newly diagnosed transplant-noneligible MM. The recommended dose of low-dose dexamethasone is 40 mg PO QD on Days 1, 8, 15, and 22 of repeated 28-day cycles.
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Investigational medicinal product name |
Carfilzomib
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Powder for solution for injection
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Routes of administration |
Solution for injection
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Dosage and administration details |
Carfilzomib 20/36 mg/m^2 on days 1,2,8,9,15,16
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Baseline characteristics reporting groups
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Reporting group title |
Overall period
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Reporting group description |
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End points reporting groups
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Reporting group title |
Experimental
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Reporting group description |
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End point title |
Primary endpoint [1] | ||||||
End point description |
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End point type |
Primary
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End point timeframe |
See publication
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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: See attached chart/documents for results |
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Attachments |
Statistical data section from publication List of reported non-SAE's List of reported SAE's |
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| No statistical analyses for this end point | |||||||
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Adverse events information
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Timeframe for reporting adverse events |
Adverse events will be reported from signing of the informed consent form until 30 days following the last dose of any drug from the protocol treatment schedule or until the start of subsequent systemic therapy for the disease under study, if earlier.
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Adverse event reporting additional description |
Adverse events occurring after 30 days after the last dose of any study drug and after the start of subsequent systemic therapy for the disease under study should also be reported if considered at least possibly related to the investigational medicinal product by the investigator.
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
CTCAE | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
4
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Reporting groups
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Reporting group title |
Experimental group
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Reporting group description |
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| Frequency threshold for reporting non-serious adverse events: 0% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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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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28 Dec 2016 |
The reason for the amendment is:
Addition of an exclusion criterion in the protocol
Update/correction of the protocol
Correction of infusion duration of Carfilzomib in patient information |
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13 Jan 2017 |
The reason for the amendment is:
Update/correction of the protocol
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22 Sep 2017 |
The reason for the amendment is:
Change of distributor of Carfilzomib. |
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04 Jul 2018 |
The reason for the amendment is:
Change of the Carfilzomib maintenance schedule
Update of the protocol and patient information |
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02 May 2019 |
The reason for the amendment is:
Addition of Almac Ireland as importer due to the upcoming Brexit
A new version of the IMPD of Carfilzomib is available. This will be sent directly to you from the pharmaceutical company Amgen. |
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28 Jan 2020 |
Reason for amendment:
Change in the number of participants (from 116 to 61). Following this change, the protocol and ICF have been updated.
Protocol changes
New local investigator at UMCG
New Investigator’s Brochure (IB) for lenalidomide (v23, v24)
New Investigator’s Brochure (IB) for carfilzomib (v19) |
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19 Jun 2020 |
No consequence of IB change |
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30 Jul 2020 |
No consequences IB Carfilzomib and lenalidomide |
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01 Apr 2021 |
Reason for amendment:
New sIMPD
New QP declaration
Comparative table of changes |
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28 Jul 2021 |
Reason for amendment
The reason for the amendment is a change in the patient information form (PIF) for new patients, following the CCMO's note regarding the transfer of subject data to countries outside the European Economic Area.
We also wish to submit the "no update memo" for the Investigator’s Brochure of Lenalidomide for notification. |
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02 Feb 2022 |
Reason for amendment
The reason for the amendment is an addendum to the patient information form (PIF) for already participating patients, following the CCMO's note regarding the transfer of subject data to countries outside the European Economic Area (Schrems II ruling).
We also wish to submit the new Investigator’s Brochures of Carfilzomib v.21 and v21.1. |
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14 Mar 2024 |
Notification of Study Termination
Through this letter, we would like to inform you about the intended termination of the HOVON 129 study as of December 31, 2024.
In the HO129 study, Carfilzomib and Lenalidomide are being investigated in combination. Lenalidomide has now already been included in the treatment guidelines for Multiple Myeloma/primary PCL patients.
The primary endpoint analysis (progression-free survival) of this study was conducted in 2023, and a publication has been accepted (see attached article).
Currently, there are still 5 patients in the Netherlands receiving maintenance treatment with lenalidomide. Additionally, 1 patient in Italy is receiving maintenance treatment with lenalidomide and carfilzomib.
Patients currently receiving maintenance treatment with lenalidomide will not be adversely affected by the termination of the HO129 study, as the treatment will be continued outside the study. For the Italian patient, carfilzomib will be made available through a compassionate use program from Amgen. |
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28 Mar 2024 |
New ICF Addendum v03
To inform patients about the early termination of the aforementioned study as of December 31, 2024. |
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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 | |||
Online references |
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| http://www.ncbi.nlm.nih.gov/pubmed/37717583 |
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