Multiple MyelomaREVLIMID-NISNCT00911105
Non -Interventional Study-Palliative Therapy of Multiple Myeloma With a Combination of Lenalidomide and Dexamethasone
An observational study of Multiple Myeloma, run by iOMEDICO AG at 20 sites in Germany.
Trial summary
Purpose of this non-interventional study is the documentation of efficacy and safety data of multiple myeloma therapy with a combined treatment of Lenalidomide and Dexamethasone in daily routine practice. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- How many people
- 101 participants
- Where
- 20 sitesGermany
- Study dates
- May 2009to Nov 2015
- 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: Patients with mutiple myeloma receiving a combination therapy with Lenalidomide and Dexamethasone.
Who may be able to join
- Patients with multiple myeloma with at least one previous therapy.
- 18 years or older
- Signed, written informed consent
Who cannot join
- Pregnancy or nursing
- All other exclusion criteria listed in SmPC (summary of product characteristics)
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
Germany20 sites
Onkologische Schwerpunktpraxis
Bad Homburg, 61348
Onkologische Schwerpunktpraxis
Berlin, 10365
Onkologisches Versorgungszentrum Friedrichshain
Berlin, 10407
Onkologische Praxis
Berlin, 13439
Onkologische Gemeinschaftspraxis
Frankfurt am Main, 60389
Praxis für Innere Medizin
Germering, 82110
MedResearch - Medizinisches Studien- und Dokumentationszentrum Leipziger Land
Groitzsch, 04539
Internistische Gemeinschaftspraxis
Güstrow, 18273
Praxis für Innere Medizin, Haematologie und Internistische Onkologie
Hamburg, 22587
Tumorpraxis Heidenheim
Heidenheim, 89518
Onkol. Gem.praxis Dr. M. Neise & Dr. A. Lollert
Krefeld, 47805
Onkologisches Zentrum Lebach
Lebach, 66822
Onkologische Gemeinschaftspraxis
Lehrte, 31275
Gemeinschaftspraxis Dr. Aldaoud - Dr. Schwarzer
Leipzig, 04289
Praxis für Haematologie und Onkologie
Mühlheim, 45468
Praxis fuer Innere Medizin
Neumarkt I. D. O., 92318
Praxis fuer Onkologie und Haematologie
Neuss, 41462
Haematologisch-Onkologische Gemeinschaftspraxis
Nordhorn, 48527
Onkologische Praxis Oldenburg
Oldenburg, 26121
Onkologische Gemeinschaftspraxis
Würselen, 52146
About this study
Official title: Combined Application of Lenalidomide and Desamethasone in the Palliative Therapy of Patients With Multiple Myeloma
Purpose of this non-interventional study is the documentation of efficacy and safety data of multiple myeloma therapy with a combined treatment of Lenalidomide and Dexamethasone in daily routine practice.
- Conditions
- Multiple Myeloma
- Keywords
- Multiple Myeloma, Non-interventional study, Lenalidomide, Dexamethasone, Observational, Time to progression, Clinical routine, Germany, Plasmacytoma
- Medical subject headings
- Multiple Myeloma, Plasmacytoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with multiple myeloma | Patients with multiple myeloma receiving second line therapy or higher. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to progression (TTP)
Measured: maximum 3 years per Patient
Secondary outcomes (8)
Overall Response Rate
Measured: maximum 3 years per Patient
Time to Treatment Discontinuation (TTD)
Measured: maximum 3 years per Patient
Overall Survival (OS)
Measured: maximum 3 years per Patient
Safety Profile
Measured: maximum 3 years per Patient
Dosage of Lenalidomide and Dexamethasone
Measured: maximum 3 years per Patient
Kidney Function
Measured: maximum 3 years per Patient
Neutropenia / Infection (Concomitant Medication)
Measured: maximum 3 years per Patient
Thrombosis Prophylaxis
Measured: maximum 3 years per Patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2009 (estimated)
- Study startMay 2009
- Primary completionApr 2012
- Study completionNov 2015
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.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- iOMEDICO AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00911105
- Sponsor's protocol ID
- IOM-0810
- Acronym
- REVLIMID-NIS
- Status last verified
- Jun 2018
- First submitted
- 28 May 2009
- Last updated
- 6 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Application of Lenalidomide and Desamethasone in the Palliative Therapy of Patients With Multiple Myeloma
- ClinicalTrials.gov ID
- NCT00911105
- Acronym / sponsor ID
- REVLIMID-NIS / IOM-0810
- Conditions
- Multiple Myeloma
- Keywords
- Multiple Myeloma, Non-interventional study, Lenalidomide, Dexamethasone, Observational, Time to progression, Clinical routine, Germany
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- iOMEDICO AGIndustry (pharma, biotech, devices)
- Study start
- May 2009
- Primary completion
- Apr 2012 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 1 Jun 2009 (estimated)
- 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.
Purpose of this non-interventional study is the documentation of efficacy and safety data of multiple myeloma therapy with a combined treatment of Lenalidomide and Dexamethasone in daily routine practice.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with multiple myeloma | – | –Patients with multiple myeloma receiving second line therapy or higher. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with mutiple myeloma receiving a combination therapy with Lenalidomide and Dexamethasone.
Key inclusion criteria (3 listed)
- Patients with multiple myeloma with at least one previous therapy.
- 18 years or older
- Signed, written informed consent
Key exclusion criteria (2 listed)
- Pregnancy or nursing
- All other exclusion criteria listed in SmPC (summary of product characteristics)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Time to progression (TTP)
Time frame: maximum 3 years per Patient
8 secondary outcomes
Overall Response Rate
Time frame: maximum 3 years per Patient
Time to Treatment Discontinuation (TTD)
Time frame: maximum 3 years per Patient
Overall Survival (OS)
Time frame: maximum 3 years per Patient
Safety Profile
Time frame: maximum 3 years per Patient
Dosage of Lenalidomide and Dexamethasone
Time frame: maximum 3 years per Patient
Kidney Function
Time frame: maximum 3 years per Patient
Neutropenia / Infection (Concomitant Medication)
Time frame: maximum 3 years per Patient
Thrombosis Prophylaxis
Time frame: maximum 3 years per Patient
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 Jun 2018.
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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.
20 sites 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 iOMEDICO AG at 20 sites 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 3 inclusion and 2 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 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites 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?
Time to progression (TTP) (time frame: maximum 3 years per Patient). 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 Jun 2018.