Clinical Trial Results:
Magnolia Study
Prolonged Protection from Bone Disease in Multiple Myeloma.
An open label phase 4 multicenter international randomised trial
Summary
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EudraCT number |
2014-002494-12 |
Trial protocol |
DK SE NO |
Global end of trial date |
15 Mar 2023
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Results information
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Results version number |
v1(current) |
This version publication date |
30 Nov 2024
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First version publication date |
30 Nov 2024
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Other versions |
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Summary report(s) |
summary magnolia |
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 |
NMSG22/14
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT02286830 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
OdenseOUH
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Sponsor organisation address |
J. B. Winsløws Vej 4, Odense, Denmark, 5000
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Public contact |
Thomas Lund, Odense University Hospital, +45 21450256, Thomas.lund2@rsyd.dk
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Scientific contact |
Thomas Lund, Odense University Hospital, +45 21450256, Thomas.lund2@rsyd.dk
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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 |
13 Nov 2024
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
15 Mar 2023
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Global end of trial reached? |
Yes
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Global end of trial date |
15 Mar 2023
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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 compare the time to PBD from year 2 to year 4 in patients treated with monthly zoledronic acid in two consecutive years compared to patients treated with monthly zoledronic acid in four consecutive years.
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Protection of trial subjects |
done according to the ethical committee approval
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
01 Dec 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 |
Norway: 82
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Country: Number of subjects enrolled |
Denmark: 111
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Worldwide total number of subjects |
193
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EEA total number of subjects |
193
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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) |
81
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From 65 to 84 years |
112
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85 years and over |
0
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Recruitment
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Recruitment details |
recruited either at diagnosis or after 2 years of zoledronic acid treatment | |||||||||
Pre-assignment
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Screening details |
Patients with MM in recruiting hospitals | |||||||||
Period 1
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Period 1 title |
overall trial (overall period)
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Is this the baseline period? |
Yes | |||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Not blinded | |||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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2 years treatment | |||||||||
Arm description |
2 years of treatment | |||||||||
Arm type |
No intervention | |||||||||
Investigational medicinal product name |
No investigational medicinal product assigned in this arm
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Arm title
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4 years treatment | |||||||||
Arm description |
4 years of treatment | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
zoledronic acid
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Concentrate and solvent for solution for injection
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Routes of administration |
Injection
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Dosage and administration details |
4-3 mg ever fouth week
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Baseline characteristics reporting groups
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Reporting group title |
2 years treatment
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Reporting group description |
2 years of treatment | ||||||||||||||||||||||||||||||||||||||||
Reporting group title |
4 years treatment
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Reporting group description |
4 years of treatment | ||||||||||||||||||||||||||||||||||||||||
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Subject analysis sets
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Subject analysis set title |
number of osteolysis in each group
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Subject analysis set type |
Full analysis | ||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
9 in the intervention arm 21 in the control arm
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End points reporting groups
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Reporting group title |
2 years treatment
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Reporting group description |
2 years of treatment | ||
Reporting group title |
4 years treatment
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Reporting group description |
4 years of treatment | ||
Subject analysis set title |
number of osteolysis in each group
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Subject analysis set type |
Full analysis | ||
Subject analysis set description |
9 in the intervention arm 21 in the control arm
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End point title |
Bone disease | ||||||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
LPLV
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Statistical analysis title |
Cox regression analysis of PBD | ||||||||||||||||
Comparison groups |
4 years treatment v 2 years treatment
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Number of subjects included in analysis |
193
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||||||
P-value |
< 0.05 | ||||||||||||||||
Method |
Regression, Cox | ||||||||||||||||
Confidence interval |
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Adverse events information
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Timeframe for reporting adverse events |
from start of trial til end of trial
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Assessment type |
Non-systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
23
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Reporting groups
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Reporting group title |
2 years treatment
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Reporting group description |
2 years of treatment | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
4 years treatment
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Reporting group description |
4 years of treatment | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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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? No | |||
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 |