Multiple MyelomaPhase 2NCT00779922
Pharmacokinetics of Lenalidomide (Revlimid®) in Patients With Multiple Myeloma and Impaired Renal Function
A Phase 2 study testing lenalidomide in people with Multiple Myeloma and Impaired Renal Function, run by Poitiers University Hospital at 1 site in France.
Trial summary
The purpose of this study is to determine the pharmacokinetic profile of Revlimid® in patients presenting with Multiple Myeloma and impaired renal function, the safety of Revlimid® in the enrolled patients population. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma, Impaired Renal Function
- What is being tested?
- lenalidomide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2008to Sep 2012
- Phase
- Phase 2
- 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
Who may be able to join
- Documented diagnosis of relapsed or refractory multiple myeloma (MM).
- Age > 18 years at the time of signing the informed consent form
- Stable renal function
Who cannot join
- Documented amyloidosis
- Any prior use of Revlimid ®
- Any contraindication to Revlimid ® and especially:
- Lack of acceptable method of birth control for female of childbearing potential (FCPB)
- Men who don't agree to use condom during the study and 4 weeks after the last study drug intake if their partner is a FCPB.
- Pregnant or breast feeding women
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine the pharmacokinetic profile of Revlimid® in patients presenting with Multiple Myeloma and impaired renal function, the safety of Revlimid® in the enrolled patients population.
and evaluate the efficacy of Revlimid®-Dexamethasone combination in patients presenting MM and impaired renal function at completion of 3 cycles of treatment.
- Conditions
- Multiple Myeloma, Impaired Renal Function
- Being tested
- lenalidomide
- Keywords
- Multiple Myeloma, impaired renal function
- Medical subject headings
- Multiple Myeloma, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lenalidomideDrug
| Study group | Role | What they receive |
|---|---|---|
| group 1 to 5 | Experimental | Not described Receives: Drug: lenalidomide |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2008 (estimated)
- Study startNov 2008
- Primary completionSep 2012
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 Poitiers University HospitalThe 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
- Interventional
- Phase
- Phase 2
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00779922
- Sponsor's protocol ID
- REVIR
- Status last verified
- Oct 2016
- First submitted
- 23 Oct 2008
- Last updated
- 11 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics of Lenalidomide (Revlimid®) in Patients With Multiple Myeloma and Impaired Renal Function
- ClinicalTrials.gov ID
- NCT00779922
- Acronym / sponsor ID
- REVIR
- Conditions
- Multiple Myeloma, Impaired Renal Function
- Keywords
- Multiple Myeloma, impaired renal function
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- Nov 2008
- Primary completion
- Sep 2012 (actual)
- First posted
- 24 Oct 2008 (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 purpose of this study is to determine the pharmacokinetic profile of Revlimid® in patients presenting with Multiple Myeloma and impaired renal function, the safety of Revlimid® in the enrolled patients population.
and evaluate the efficacy of Revlimid®-Dexamethasone combination in patients presenting MM and impaired renal function at completion of 3 cycles of treatment.
Study design
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| group 1 to 5 | Experimental | Drug: lenalidomide |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Documented diagnosis of relapsed or refractory multiple myeloma (MM).
- Age > 18 years at the time of signing the informed consent form
- Stable renal function
Key exclusion criteria (6 listed)
- Documented amyloidosis
- Any prior use of Revlimid ®
- Any contraindication to Revlimid ® and especially:
- Lack of acceptable method of birth control for female of childbearing potential (FCPB)
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 |
|---|---|---|
| lenalidomide | Drug | group 1 to 5 |
Primary outcome
Not reported in the source record.
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 11 Oct 2016.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing lenalidomide in people with Multiple Myeloma and Impaired Renal Function, run by Poitiers University Hospital at 1 site in France.
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 6 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 11 Oct 2016. 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 France. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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.
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 11 Oct 2016.