Multiple MyelomaNCT03001804
Use Lenalidomide (Revlimid®) in Combination With Dexamethasone in Clinical Practice for the Treatment of Newly Diagnosed Multiple Myeloma (MM) Transplant Ineligible Patients
An observational study of Multiple Myeloma, run by Celgene at 12 sites in Austria.
Trial summary
The aim of this non-interventional study is to collect primarily the percentage of patients who receive the full dose of dexamethasone (20 or 40 mg orally once daily on days 1, 8, 15 and 22 of the repetitive 28-day cycles, 20 mg in >75 year old patients) in the registered indication under practice conditions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- Type of treatment
- Pill or oral medicine
- How many people
- 29 participants
- Where
- 12 sitesAustria
- Study dates
- 30 Jun 2017to 16 Dec 2022
- 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 scheduled for therapy of untreated multiple myeloma, where stem cell transplantation cannot be performed
Who may be able to join
- Signed Informed Consent
- Age ≥ 18 years
- Newly diagnosed Multiple Myeloma
- Not suitable for stem cell transplantation
- Appropriate methods of contraception according to the Risk Minimization Program (RMP)
- Adequate thrombosis prophylaxis
Who cannot join
- Pregnant and lactating females
- No other formal exclusion criteria according to most recent European Summary of Product Characteristics (SmPC)
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
Austria12 sites
Landeskrankenhaus Kirchdorf
Kirchdorf, 4560
Klinikum Klagenfurt am Wörthersee
Klagenfurt, 9020
Kepleruniversitätsklinikum GmbH, Hämatologie und Internistische Onkologie
Linz, 4020
Ordensklinikum Linz GmbH Elisabethinen
Linz, 4020
Krankenhaus der Barmherzigen Schwestern Ried Innere Medizin 1
Ried, 4910
Landeskrankenhaus Steyr - Innere Medizin
Steyr, 4400
AKH, Innere Medizin I, Klinische Abteilung für Hämatologie und Hämostaseologie
Vienna, 1090
Klinische Abteilung für Hämatologie und Hämostaseologie
Vienna, 1090
St. Josef Krankenhaus
Vienna, 1130
Wilhelminenspital, 1. Med.Abteilung, Zentrum für Onkologie
Vienna, 1160
Salzkammergut-Klinikum Vöcklabruck Abteilung Innere Medizin
Vöcklabruck, 4840
LKH Wiener Neustadt, Innere Medizin
Wiener Neustadt, 2700
About this study
Official title: Use of Lenalidomide (Revlimid®) in Combination With Dexamethasone in Untreated Non-transplantable Multiple Myeloma in Practice
The aim of this non-interventional study is to collect primarily the percentage of patients who receive the full dose of dexamethasone (20 or 40 mg orally once daily on days 1, 8, 15 and 22 of the repetitive 28-day cycles, 20 mg in >75 year old patients) in the registered indication under practice conditions.
Read the detailed description
Multiple myeloma is still a persistent and life-threatening blood cancer that is characterised by tumour proliferation and suppression of the immune system. It is a rare but incurable disease. On average, multiple myeloma is diagnosed in people 65-74 years of age, and the majority of newly diagnosed patients may not be eligible for more aggressive treatment options such as high-dose chemotherapy with stem cell transplant. In February 2015 REVLIMID® (lenalidomide) was approved in combination with dexamethasone for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for transplant. Furthermore, in May 2019 REVLIMID® was approved in combination with bortezomib and dexamethasone for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for transplant.
Looking in more detail at the combination of lenalidomide and dexamethasone, the role and especially the most adequate and effective dosage of dexamethasone in long term use with lenalidomide is not clearly defined or well characterised It is therefore of great relevance to gain insights into the clinical practice and the routine of dexamethasone management and dosing in long term use with Revlimid.
- Conditions
- Multiple Myeloma
- Keywords
- Multiple Myeloma, Revlimid, Lenalidomide, Non-transplantable
- Medical subject headings
- Multiple Myeloma
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 |
|---|---|---|
| Cohort A | Lenalidomide 25mg or 10mg (reduced renal function 30 ≤ ClCr < 50mg/min) capsules by mouth (PO) on days 1 through 21 of a 28 day cycle and Dexamethasone 40mg PO (≤75 years) or 20mg (>75years) on Days 1, 8, 15, 22 of a 28 day cycle until progression or unacceptable toxicity | |
| Cohort B | Initial treatment (up to 8 cycles): Lenalidomide 25mg or 10mg (reduced renal function 30 ≤ ClCr < 50mg/min) capsule by mouth (PO) on day 1 through 14 of a 21 day cycle, Bortezomib 1.3mg/m2 s.c. on day 1, 4, 8, and 11 of a 21 day cycle, and Dexamethasone 20mg PO on days 1,2,4,5,8,9,11,12 of a 21 day cycle; Successive Treatment: Lenalidomide 25mg or 10mg (reduced renal function 30 ≤ ClCr < 50mg/min) capsules by mouth (PO) on days 1 through 21 of a 28 day cycle and Dexamethasone 40mg PO (≤75 years) or 20mg (>75years) on Days 1, 8, 15, 22 of a 28 day cycle until progression or unacceptable toxicity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients receiving dexamethasone after 6 months of treatment
Number of patients receiving 20mg or 40mg dexamethasone on day 1, 8, 15, 22 of a 28 day cycle after 6 months of treatment
Measured: up to 2 years
Secondary outcomes (3)
Number of patients with Deep Venous Thrombosis (VTE) prophylaxis
Number of patients that receive VTE prophylaxis
Measured: up to 2 years
Over all response rate (ORR)
Number of patients that achieve a response
Measured: up to 2 years
Adverse Events (AEs)
Number of patients with an adverse events
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2016 (estimated)
- Study start30 Jun 2017
- Primary completion16 Dec 2022
- Study completion16 Dec 2022
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 CelgeneThe 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
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celgene
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03001804
- Sponsor's protocol ID
- CC-5013-MM-037
- Status last verified
- Jun 2023
- First submitted
- 19 Dec 2016
- Last updated
- 9 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Lenalidomide (Revlimid®) in Combination With Dexamethasone in Untreated Non-transplantable Multiple Myeloma in Practice
- ClinicalTrials.gov ID
- NCT03001804
- Acronym / sponsor ID
- CC-5013-MM-037
- Conditions
- Multiple Myeloma
- Keywords
- Multiple Myeloma, Revlimid, Lenalidomide, Non-transplantable
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- CelgeneIndustry (pharma, biotech, devices)
- Study start
- 30 Jun 2017 (actual)
- Primary completion
- 16 Dec 2022 (actual)
- Study completion
- 16 Dec 2022 (actual)
- First posted
- 23 Dec 2016 (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.
The aim of this non-interventional study is to collect primarily the percentage of patients who receive the full dose of dexamethasone (20 or 40 mg orally once daily on days 1, 8, 15 and 22 of the repetitive 28-day cycles, 20 mg in >75 year old patients) in the registered indication under practice conditions.
Detailed description
Multiple myeloma is still a persistent and life-threatening blood cancer that is characterised by tumour proliferation and suppression of the immune system. It is a rare but incurable disease. On average, multiple myeloma is diagnosed in people 65-74 years of age, and the majority of newly diagnosed patients may not be eligible for more aggressive treatment options such as high-dose chemotherapy with stem cell transplant. In February 2015 REVLIMID® (lenalidomide) was approved in combination with dexamethasone for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for transplant. Furthermore, in May 2019 REVLIMID® was approved in combination with bortezomib and dexamethasone for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for transplant.
Looking in more detail at the combination of lenalidomide and dexamethasone, the role and especially the most adequate and effective dosage of dexamethasone in long term use with lenalidomide is not clearly defined or well characterised It is therefore of great relevance to gain insights into the clinical practice and the routine of dexamethasone management and dosing in long term use with Revlimid.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort A | – | –Lenalidomide 25mg or 10mg (reduced renal function 30 ≤ ClCr < 50mg/min) capsules by mouth (PO) on days 1 through 21 of a 28 day cycle and Dexamethasone 40mg PO (≤75 years) or 20mg (>75years) on Days 1, 8, 15, 22 of a 28 day cycle until progression or unacceptable toxicity |
| Cohort B | – | –Initial treatment (up to 8 cycles): Lenalidomide 25mg or 10mg (reduced renal function 30 ≤ ClCr < 50mg/min) capsule by mouth (PO) on day 1 through 14 of a 21 day cycle, Bortezomib 1.3mg/m2 s.c. on day 1, 4, 8, and 11 of a 21 day cycle, and Dexamethasone 20mg PO on days 1,2,4,5,8,9,11,12 of a 21 day cycle; Successive Treatment: Lenalidomide 25mg or 10mg (reduced renal function 30 ≤ ClCr < 50mg/min) capsules by mouth (PO) on days 1 through 21 of a 28 day cycle and Dexamethasone 40mg PO (≤75 years) or 20mg (>75years) on Days 1, 8, 15, 22 of a 28 day cycle until progression or unacceptable toxicity |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled for therapy of untreated multiple myeloma, where stem cell transplantation cannot be performed
Key inclusion criteria (6 listed)
- Signed Informed Consent
- Age ≥ 18 years
- Newly diagnosed Multiple Myeloma
- Not suitable for stem cell transplantation
- Appropriate methods of contraception according to the Risk Minimization Program (RMP)
Key exclusion criteria (2 listed)
- Pregnant and lactating females
- No other formal exclusion criteria according to most recent European Summary of Product Characteristics (SmPC)
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
Number of patients receiving dexamethasone after 6 months of treatment
Time frame: up to 2 years
Number of patients receiving 20mg or 40mg dexamethasone on day 1, 8, 15, 22 of a 28 day cycle after 6 months of treatment
3 secondary outcomes
Number of patients with Deep Venous Thrombosis (VTE) prophylaxis
Time frame: up to 2 years
Over all response rate (ORR)
Time frame: up to 2 years
Adverse Events (AEs)
Time frame: up to 2 years
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 9 Jun 2023.
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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.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
12 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 Celgene at 12 sites in Austria.
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 6 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 9 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Austria. 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?
Number of patients receiving dexamethasone after 6 months of treatment (time frame: up to 2 years). 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 9 Jun 2023.