Multiple MyelomaMYLENENCT05284591
Non-interventional Study to Evaluate Patient and Healthcare Provider Satisfaction of Daratumumab Use in the Treatment of First-line Daratumumab, Lenalidomide, Dexamethasone (DRd) Multiple Myeloma Patients in Germany Depending on Application Route (sc or iv)
An observational study of Multiple Myeloma and Newly Diagnosed, run by iOMEDICO AG at 1 site in Germany.
Trial summary
MYLENE is a prospective, multicenter, NIS to evaluate the patient and HCP satisfaction of sc and iv application of daratumumab in routine clinical practice in Germany. Patients observed in this study will be transplant ineligible NDMM patients for which the physician foresees an anti-myeloma therapy using DRd regimen… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma, Newly Diagnosed, Transplant Ineligible
- What is being tested?
- Daratumumab
- Type of treatment
- Injection or infusion
- How many people
- 96 participants
- Where
- 1 siteGermany
- Study dates
- 6 Jul 2022to 20 Sep 2024
- 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: MYLENE is focusing on the satisfaction of all involved stakeholders (i.e., patients and HCPs) mainly in private practices, since this patient collective is treated preferentially in these institutions, allowing to receive direct feedback about the use of daratumumab sc application and its potential hurdles or/and limitations.
Who may be able to join
- Patients aged 18 years or older
- Newly diagnosed multiple myeloma (NDMM) and decision for first-line treatment with daratumumab/lenalidomide/dexamethasone (DRd) according to SmPCs of daratumumab
- Each patient must sign an informed consent form (ICF) indicating that he or she understands the purpose of the study and is willing to participate in the study
- Willingness and ability to read, understand and complete patients' questionnaires due to the primary objective of the NIS (i.e., patient satisfaction using the Patient Satisfaction and Time Questionnaire (PatSTQ)).
Who cannot join
- Participation in an interventional clinical trial (participation in another non-Janssen sponsored NIS or registry is allowed)
- Prior anti-myeloma therapy, with the exception of local radiation therapy or an emergency use of a short course of corticosteroids before treatment
- Any restrictions/limitations preventing to be treated with DRd as per SmPCs of daratumumab
Trial locations and contacts
1 site in 1 country.
Germany1 site
Centrum für Hämatologie und Onkologie Bethanien
Frankfurt am Main, Hesse, 60389
About this study
Official title: Prospective, Multicenter, Non-interventional Study to Evaluate Patient and Healthcare Provider Satisfaction of Daratumumab Use in the Treatment of First-line Daratumumab, Lenalidomide, Dexamethasone (DRd) Multiple Myeloma Patients as Per Routine Clinical Practice in Germany Depending on Application Route (sc or iv)
MYLENE is a prospective, multicenter, NIS to evaluate the patient and HCP satisfaction of sc and iv application of daratumumab in routine clinical practice in Germany. Patients observed in this study will be transplant ineligible NDMM patients for which the physician foresees an anti-myeloma therapy using DRd regimen as per local label.
250 NDMM patients treated with DRd will be enrolled (excluding screening failures, i.e., enrolled patients not fulfilling selection criteria identified before treatment start will be replaced) within 12 months in a proportion of approximately 1/3 patients receiving daratumumab sc and 2/3 patients receiving daratumumab iv as per physician's decision.
Read the detailed description
Therapy options for MM are mainly dependent on the age and fitness of the patients. NDMM patients up to the age of 65-70 years in whom autologous stem cell transplantation is not indicated, anti-myeloma treatment traditionally consists of systemic chemotherapy, with adjunctive use of radiation or surgery in selected cases associated with extramedullary disease. However, the therapeutic landscape of multiple myeloma progressed in the past decade with the introduction of immunomodulatory agents, proteasome inhibitors and anti-CD38 antibodies, like Daratumumab.
After approval of daratumumab iv in May 2016, the sc daratumumab application route was approved in June 2020 in Germany. Real-world evidence data, however, are not yet available neither related to daily experience nor to satisfaction with daratumumab sc application nor to the proportion of patients potentially switching from daratumumab iv to sc application.
MYLENE aims to close these gaps with focus on NDMM patients who are ineligible for autologous stem cell transplantation and who will be treated with DRd; this is to guarantee a homogenous patient population.
All aspects of treatment and clinical management of patients will be in accordance with local clinical practice and applicable local regulations, and at the discretion of the healthcare provider (or treating physician where different). Only data available per clinical practice will be collected within this study. Additionally, where permitted in accordance with local regulations, healthcare providers will be asked to obtain patient-reported outcome (PRO) data from patients within this study. Despite use of PROs and HCP as well as physician questionnaires, the design is non-interventional due to the fact that the questionnaires are structured documentation aids to document questions that are routinely part of the dialog between patient and physician or HCP during the patient visit and/or drug administration or that are considered by the HCP when evaluate treatment for the patient but are not documented in the medical record.
MYLENE is unique as it is focusing on the satisfaction of all involved stakeholders (i.e., patients and HCPs) under real-word conditions and mainly in private practices, since this patient collective is treated preferentially in these institutions, allowing to receive direct feedback about the use of daratumumab sc application and its potential hurdles or/and limitations. Furthermore, this study will provide insights on how the sc/iv application is managed in clinical routine as well as how it is perceived by medical professionals over time.
This NIS will be analyzed exploratively and is hence not designed to confirm or refute a predefined hypothesis.
- Conditions
- Multiple Myeloma, Newly Diagnosed, Transplant Ineligible, Patient Satisfaction, Patient Preference, Personal Satisfaction
- Being tested
- Daratumumab
- Keywords
- Daratumumab, DARZALEX, Lenalidomide, Dexamethasone
- Medical subject headings
- Multiple Myeloma, Patient Satisfaction, Patient Preference, Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DaratumumabBiological
Also called Darzalex
intravenous or subcutaneous
| Study group | Role | What they receive |
|---|---|---|
| DRd with daratumumab iv de novo | Patients either continue DRd with daratumumab iv, switch to daratumumab sc or switch multiple times iv/sc Receives: Biological: Daratumumab | |
| DRd with daratumumab sc de novo | Patients either continue DRd with daratumumab sc, switch to daratumumab iv or switch multiple times sc/iv Receives: Biological: Daratumumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Satisfaction and Time with the application route of daratumumab (iv/sc)
The primary objective of this NIS is to exploratively analyze patients' satisfaction of sc and iv application of daratumumab over time as measured by the "Patient Satisfaction and Time Questionnaire" (PatSTQ).
Overall patients´ satisfaction with daratumumab administration will be displayed as the result of one defined question in the PatSTQ, with descriptive statistics and boxplots.
Results of PatSTQ will be displayed with frequencies per group and by time point. Additionally, stacked bar plots with questionnaire results (including missings) per item and time point will be presented
Measured: For patients with continuous application route the time frame will be 12 months. For patients with switch of application route, at least 4 daratumumab applications after the first switch should be documented.
Secondary outcomes (9)
HCP satisfaction and time with the application route of daratumumab (iv/sc)
The secondary objective of this NIS is to assess HCPs' satisfaction of sc and iv application over time as measured by the "HCP Satisfaction and Time Questionnaire - patient specific" (HSTQ-ps).
HCPs' application route satisfaction will be displayed by questionnaire time point as result of the HSTQ - ps questionnaire with frequencies for questions and with descriptive statistics.
Measured: Time frame will be approx. 12 months depending on switch of application route.
Proportion of HCP active time spent on activities
The proportion of HCP active time spent on activities (drug preparation, drug administration, patient care/patient monitoring) over time
Measured: Time frame will be approx. 12 months depending on switch of application route.
Patients' chair time over time
Patients' chair time over time
Measured: Time frame will be approx. 12 months depending on switch of application route.
Patients' overall time spent at doctor's office
Patients' overall time spent at doctor's office
Measured: Time frame will be approx. 12 months depending on switch of application route.
Switch rate (proportion of patients) of daratumumab application routes
The switch rate (proportion of patients) of daratumumab application routes during 12 months of study participation under real-word conditions
Measured: Time frame will be approx. 12 months depending on switch of application route.
Median switch time
Median switch time
Measured: Time frame will be approx. 12 months depending on switch of application route.
Main reasons for sc or iv application selection
The main reasons for sc or iv application selection evaluated by both, the "Physician Therapy Decision Questionnaire - general" (PTDQ-g) at study start and at the end of study (i.e., study close-out) and by the "Physician Therapy Decision Questionnaire - patient specific" (PTDQ-ps) at baseline and at switch of the application route
Measured: Time frame will be from date of site activation (start of potential enrolment at site) to site close-out (up to 14 months after last patient in)..
Impact of different factors on therapy decision and application route selection (PTDQ-ps)
The impact of different factors on therapy decision and application route selection will be displayed as parameter estimates for selected fixed covariates (age, cytogenetics (high vs standard) and relevant comorbidities) in a mixed effects logistic regression model with the result of PTDQ-ps as outcome.
The treating physician selects up to two main reasons why the (new) application route (sc or iv) of daratumumab for a patient is chosen.
Measured: Time frame will be approx. 12 months depending on switch of application route.
Patients' preference of the application route
Patients' preference of the application route (only for patients switching from one application route to another) as measured by the "Patient Preference Questionnaire" (PatPQ).
The patient selects which method of daratumumab administration (iv or sc) is preferred and up to two reasons for the preference.
Measured: Time frame will be approx. 12 months depending on switch of application route.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2022
- Study start6 Jul 2022
- Primary completion20 Sep 2024
- Study completion20 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by iOMEDICO AGThe sponsor's other registered studies.
- 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
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- iOMEDICO AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Wolfgang Knauf, Prof. Dr., Principal investigator, Centrum für Hämatologie und Onkologie Bethanien, Frankfurt/ Main
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05284591
- Sponsor's protocol ID
- 54767414MMY4047
- Acronym
- MYLENE
- Status last verified
- Sep 2024
- First submitted
- 17 Feb 2022
- Last updated
- 1 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
von der Heyde E, Reiser M, Baumgartner V, Englisch C, Frank O, Buchholz S, Kreimendahl F, Uhlig J, Burkle D, Knauf W. Patient and Healthcare Provider Satisfaction With Subcutaneous Versus Intravenous Administration of Daratumumab in Combination With Lenalidomide and Dexamethasone as First-Line Treatment in Patients With Newly Diagnosed Non-Transplant Eligible Multiple Myeloma: Final Results of the MYLENE Study. Eur J Haematol. 2026 Oct 1. doi: 10.1111/ejh.70333. Online ahead of print.
PubMed 42820722
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multicenter, Non-interventional Study to Evaluate Patient and Healthcare Provider Satisfaction of Daratumumab Use in the Treatment of First-line Daratumumab, Lenalidomide, Dexamethasone (DRd) Multiple Myeloma Patients as Per Routine Clinical Practice in Germany Depending on Application Route (sc or iv)
- ClinicalTrials.gov ID
- NCT05284591
- Acronym / sponsor ID
- MYLENE / 54767414MMY4047
- Conditions
- Multiple Myeloma, Newly Diagnosed, Transplant Ineligible, Patient Satisfaction, Patient Preference, Personal Satisfaction
- Keywords
- Daratumumab, DARZALEX, Lenalidomide, Dexamethasone
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- iOMEDICO AGIndustry (pharma, biotech, devices)
- Study start
- 6 Jul 2022 (actual)
- Primary completion
- 20 Sep 2024 (actual)
- Study completion
- 20 Sep 2024 (actual)
- First posted
- 17 Mar 2022 (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.
MYLENE is a prospective, multicenter, NIS to evaluate the patient and HCP satisfaction of sc and iv application of daratumumab in routine clinical practice in Germany. Patients observed in this study will be transplant ineligible NDMM patients for which the physician foresees an anti-myeloma therapy using DRd regimen as per local label.
250 NDMM patients treated with DRd will be enrolled (excluding screening failures, i.e., enrolled patients not fulfilling selection criteria identified before treatment start will be replaced) within 12 months in a proportion of approximately 1/3 patients receiving daratumumab sc and 2/3 patients receiving daratumumab iv as per physician's decision.
Detailed description
Therapy options for MM are mainly dependent on the age and fitness of the patients. NDMM patients up to the age of 65-70 years in whom autologous stem cell transplantation is not indicated, anti-myeloma treatment traditionally consists of systemic chemotherapy, with adjunctive use of radiation or surgery in selected cases associated with extramedullary disease. However, the therapeutic landscape of multiple myeloma progressed in the past decade with the introduction of immunomodulatory agents, proteasome inhibitors and anti-CD38 antibodies, like Daratumumab.
After approval of daratumumab iv in May 2016, the sc daratumumab application route was approved in June 2020 in Germany. Real-world evidence data, however, are not yet available neither related to daily experience nor to satisfaction with daratumumab sc application nor to the proportion of patients potentially switching from daratumumab iv to sc application.
MYLENE aims to close these gaps with focus on NDMM patients who are ineligible for autologous stem cell transplantation and who will be treated with DRd; this is to guarantee a homogenous patient population.
All aspects of treatment and clinical management of patients will be in accordance with local clinical practice and applicable local regulations, and at the discretion of the healthcare provider (or treating physician where different). Only data available per clinical practice will be collected within this study. Additionally, where permitted in accordance with local regulations, healthcare providers will be asked to obtain patient-reported outcome (PRO) data from patients within this study. Despite use of PROs and HCP as well as physician questionnaires, the design is non-interventional due to the fact that the questionnaires are structured documentation aids to document questions that are routinely part of the dialog between patient and physician or HCP during the patient visit and/or drug administration or that are considered by the HCP when evaluate treatment for the patient but are not documented in the medical record.
MYLENE is unique as it is focusing on the satisfaction of all involved stakeholders (i.e., patients and HCPs) under real-word conditions and mainly in private practices, since this patient collective is treated preferentially in these institutions, allowing to receive direct feedback about the use of daratumumab sc application and its potential hurdles or/and limitations. Furthermore, this study will provide insights on how the sc/iv application is managed in clinical routine as well as how it is perceived by medical professionals over time.
This NIS will be analyzed exploratively and is hence not designed to confirm or refute a predefined hypothesis.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DRd with daratumumab iv de novo | – | Biological: DaratumumabPatients either continue DRd with daratumumab iv, switch to daratumumab sc or switch multiple times iv/sc |
| DRd with daratumumab sc de novo | – | Biological: DaratumumabPatients either continue DRd with daratumumab sc, switch to daratumumab iv or switch multiple times sc/iv |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- MYLENE is focusing on the satisfaction of all involved stakeholders (i.e., patients and HCPs) mainly in private practices, since this patient collective is treated preferentially in these institutions, allowing to receive direct feedback about the use of daratumumab sc application and its potential hurdles or/and limitations.
Key inclusion criteria (4 listed)
- Patients aged 18 years or older
- Newly diagnosed multiple myeloma (NDMM) and decision for first-line treatment with daratumumab/lenalidomide/dexamethasone (DRd) according to SmPCs of daratumumab
- Each patient must sign an informed consent form (ICF) indicating that he or she understands the purpose of the study and is willing to participate in the study
- Willingness and ability to read, understand and complete patients' questionnaires due to the primary objective of the NIS (i.e., patient satisfaction using the Patient Satisfaction and Time Questionnaire (PatSTQ)).
Key exclusion criteria (3 listed)
- Participation in an interventional clinical trial (participation in another non-Janssen sponsored NIS or registry is allowed)
- Prior anti-myeloma therapy, with the exception of local radiation therapy or an emergency use of a short course of corticosteroids before treatment
- Any restrictions/limitations preventing to be treated with DRd as per SmPCs of daratumumab
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 |
|---|---|---|
| DaratumumabAlso: Darzalexintravenous or subcutaneous | Biological | DRd with daratumumab iv de novo, DRd with daratumumab sc de novo |
Primary outcome
Patient Satisfaction and Time with the application route of daratumumab (iv/sc)
Time frame: For patients with continuous application route the time frame will be 12 months. For patients with switch of application route, at least 4 daratumumab applications after the first switch should be documented.
The primary objective of this NIS is to exploratively analyze patients' satisfaction of sc and iv application of daratumumab over time as measured by the "Patient Satisfaction and Time Questionnaire" (PatSTQ). Overall patients´ satisfaction with daratumumab administration will be displayed as the result of one defined question in the PatSTQ, with descriptive statistics and boxplots. Results of PatSTQ will be displayed with frequencies per group and by time point. Additionally, stacked bar plots with questionnaire results (including missings) per item and time point will be presented
9 secondary outcomes
HCP satisfaction and time with the application route of daratumumab (iv/sc)
Time frame: Time frame will be approx. 12 months depending on switch of application route.
Proportion of HCP active time spent on activities
Time frame: Time frame will be approx. 12 months depending on switch of application route.
Patients' chair time over time
Time frame: Time frame will be approx. 12 months depending on switch of application route.
Patients' overall time spent at doctor's office
Time frame: Time frame will be approx. 12 months depending on switch of application route.
Switch rate (proportion of patients) of daratumumab application routes
Time frame: Time frame will be approx. 12 months depending on switch of application route.
Median switch time
Time frame: Time frame will be approx. 12 months depending on switch of application route.
Main reasons for sc or iv application selection
Time frame: Time frame will be from date of site activation (start of potential enrolment at site) to site close-out (up to 14 months after last patient in)..
Impact of different factors on therapy decision and application route selection (PTDQ-ps)
Time frame: Time frame will be approx. 12 months depending on switch of application route.
Patients' preference of the application route
Time frame: Time frame will be approx. 12 months depending on switch of application route.
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 1 Oct 2024.
- Derived from this study: PubMed 42820722von der Heyde E, Reiser M, Baumgartner V, Englisch C, Frank O, Buchholz S, Kreimendahl F, Uhlig J, Burkle D, Knauf W. Patient and Healthcare Provider Satisfaction With Subcutaneous Versus Intravenous Administration of Daratumumab in Combination With Lenalidomide and Dexamethasone as First-Line Treatment in Patients With Newly Diagnosed Non-Transplant Eligible Multiple Myeloma: Final Results of the MYLENE Study. Eur J Haematol. 2026 Oct 1. doi: 10.1111/ejh.70333. Online ahead of print.
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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.
Wolfgang Knauf, Prof. Dr. principal investigator
Centrum für Hämatologie und Onkologie Bethanien, Frankfurt/ Main
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 and Newly Diagnosed, run by iOMEDICO AG at 1 site in Germany.
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 4 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 1 Oct 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 Germany. 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?
Patient Satisfaction and Time with the application route of daratumumab (iv/sc) (time frame: For patients with continuous application route the time frame will be 12 months. For patients with switch of application route, at least 4 daratumumab applications after the first switch should be documented.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05284591, which also lists 1 linked publication.
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 1 Oct 2024.