Multiple MyelomaPhase 1REVALLONCT01421927
Lenalidomide After Reduced-intensity Allogeneic Stem Cell Transplantation for Relapsed Multiple Myeloma
A Phase 1 study testing Lenalidomide in people with Multiple Myeloma, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
Allogeneic stem cell transplantation (Allo-SCT) in multiple myeloma (MM) remains a controversial topic because of a high risk of relapse and a significant transplant-related mortality (TRM). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Lenalidomide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteFrance
- Study dates
- Aug 2011to Oct 2014
- Phase
- Phase 1
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18 to 65 years
- Multiple Myeloma in 2nd or 3rd complete or partial response*
- Disease never refractory to lenalidomide
- Lenalidomide treatment ≤ 9 months
- HLA related or unrelated donor (matched 10/10 or mismatched 9/10 HLA-C high resolution level or HLA-DQ high or low resolution level)
- Insured under Social Security
- Information and consent signed
Who cannot join
- Stable or progressive disease
- Hypersensitivity to lenalidomide or excipients
- Lenalidomide treatment > 9 months
- Absence of efficient contraception in women or men
- Cardiac insufficiency (ejection fraction < 50% by echocardiography)
- Pulmonary disease characterized by DLCO < 60%
Show all 13Show fewer
- Severe renal insufficiency (clearance of creatinin < 30 ml/min)
- Hepatic disease characterized by ASAT and/or ALAT and/or total bilirubin > 2 times the upper normal value except in case of Gilbert's disease
- Bacterial, Viral or Fungal uncontrolled infections
- No contraceptive method for Female subjects of childbearing potential
- No use of condoms for males subjects
- Pregnant or breast feeding woman
- History of previous cancer (other than myeloma) except if the patient is in complete remission for more than 5 years.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety of a Maintenance Therapy With Lenalidomide After Reduced-intensity Allogeneic Stem Cell Transplantation for Chemosensitive Relapsed Multiple Myeloma
Allogeneic stem cell transplantation (Allo-SCT) in multiple myeloma (MM) remains a controversial topic because of a high risk of relapse and a significant transplant-related mortality (TRM). In an effort to reduce the TRM, most allogeneic transplants in MM are now performed after reduced-intensity conditioning regimens. In these conditions, TRM usually range from 10 to 20%. However, reducing the intensity of the conditioning invariably increases the incidence of relapse to 45 to 60%. As a consequence, post-transplant strategies to reduce the incidence of relapse after reduced-intensity Allo-SCT should be considered and evaluated.
Read the detailed description
Lenalidomide has a significant clinical activity in patients with relapsed or refractory MM and in patients relapsing after Allo-SCT. The mechanisms of action involve immunomodulation, anti-angiogenesis activity, direct anti tumor activity and effects on microenvironment. So far, the experience with lenalidomide after Allo-SCT has been limited to patients with progressive disease. In such patients, some responses are observed but most of them are transient with median progression-free survivals of less than one year. Lenalidomide used as maintenance therapy in patients with persistent rather than progressive disease might be a better approach.
Lenalidomide is interesting in the Allo-SCT setting also because some recent studies focusing on its immunological properties have suggested that the molecule could stimulate the graft versus myeloma effect. First, it has been demonstrated in vitro that lenalidomide can inhibit the proliferation and the suppressor function of regulatory T cells. Secondly, a clinical study using lenalidomide as salvage therapy after Allo-SCT demonstrated an increase of activated T cells and NK cells. Finally, a case report described a patient's response to lenalidomide associated with the development of an acute graft versus host disease.
Taken together, these data suggest that patients with MM who have a persistent disease after a reduced-intensity Allo-SCT might benefit from a post-transplant maintenance strategy with lenalidomide by a direct anti-tumor effect and a stimulation of the graft versus myeloma effect. The primary objective of this study is to evaluate the safety of such a strategy.
- Conditions
- Multiple Myeloma
- Being tested
- Lenalidomide
- Keywords
- lenalidomide
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LenalidomideDrug
Start between Day+100 and Day+120 post-transplant
- Initial dose: 5 mg/day every day
In the absence of thrombocytopenia < 75000/mm3 or neutropenia < 1000/mm3 (with or without G-CSF), increase to the upper level than the ongoing one every third month up to the maximal dose of 15 mg/day every day.
- Duration
- until persistent stringent complete response for 3 months
- or progression defined by IMWG criteria12
- or unacceptable toxicity
- or one year after transplant
| Study group | Role | What they receive |
|---|---|---|
| lenalidomide | Experimental | Not described Receives: Drug: Lenalidomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of lenalidomide
The main judgement criteria will be the occurrence of adverse events (AE) requiring the definitive interruption of lenalidomide :
- Grade 3 or 4 adverse event according to the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 occurring at the lowest dose of lenalidomide or
- Steroid-refractory acute (Seattle criteria) or chronic (National Institutes of Health (NIH) criteria) graft versus host disease or
- Transplant-related death
Measured: 1 year
Secondary outcomes (8)
One-year Progression-Free Survival
Progression defined according to International Myeloma Working Group (IMWG) criteria
Measured: one year
One-year Overall Survival
all-cause death
Measured: one year
One-year Transplant Related Mortality
Measured: one year
One-year incidence of Relapse/Progression
Progression defined according to IMWG criteria
Measured: one year
Incidences of acute and chronic Graft versus Host Disease
Acute graft versus host disease according to Seattle criteria. Chronic graft versus host disease according to NIH criteria.
Measured: one year
Immunophenotypic analysis of blood B, T, NK and dendritic cells
Measured: one year
Chimerism analysis
Measured: one year
safety of lenalidomide
all adverse events, graded according to NCI-CTCAE v3
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2011 (estimated)
- Study startAug 2011
- Primary completionOct 2014
- Study completionOct 2014
Why it stopped: target number of inclusion not reached
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 University Hospital, BordeauxThe 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephane Vigouroux, Dr, Principal investigator, University Hospital, BordeauxAdélaïde DOUSSAU, Dr, Study chair, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01421927
- Sponsor's protocol ID
- CHUBX 2010/01
- Other IDs
- 2010-023203-98
- Acronym
- REVALLO
- Status last verified
- Jul 2015
- First submitted
- 22 Aug 2011
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety of a Maintenance Therapy With Lenalidomide After Reduced-intensity Allogeneic Stem Cell Transplantation for Chemosensitive Relapsed Multiple Myeloma
- ClinicalTrials.gov ID
- NCT01421927
- Acronym / sponsor ID
- REVALLO / CHUBX 2010/01
- Conditions
- Multiple Myeloma
- Keywords
- lenalidomide
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: target number of inclusion not reached
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 23 Aug 2011 (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.
Allogeneic stem cell transplantation (Allo-SCT) in multiple myeloma (MM) remains a controversial topic because of a high risk of relapse and a significant transplant-related mortality (TRM). In an effort to reduce the TRM, most allogeneic transplants in MM are now performed after reduced-intensity conditioning regimens. In these conditions, TRM usually range from 10 to 20%. However, reducing the intensity of the conditioning invariably increases the incidence of relapse to 45 to 60%. As a consequence, post-transplant strategies to reduce the incidence of relapse after reduced-intensity Allo-SCT should be considered and evaluated.
Detailed description
Lenalidomide has a significant clinical activity in patients with relapsed or refractory MM and in patients relapsing after Allo-SCT. The mechanisms of action involve immunomodulation, anti-angiogenesis activity, direct anti tumor activity and effects on microenvironment. So far, the experience with lenalidomide after Allo-SCT has been limited to patients with progressive disease. In such patients, some responses are observed but most of them are transient with median progression-free survivals of less than one year. Lenalidomide used as maintenance therapy in patients with persistent rather than progressive disease might be a better approach.
Lenalidomide is interesting in the Allo-SCT setting also because some recent studies focusing on its immunological properties have suggested that the molecule could stimulate the graft versus myeloma effect. First, it has been demonstrated in vitro that lenalidomide can inhibit the proliferation and the suppressor function of regulatory T cells. Secondly, a clinical study using lenalidomide as salvage therapy after Allo-SCT demonstrated an increase of activated T cells and NK cells. Finally, a case report described a patient's response to lenalidomide associated with the development of an acute graft versus host disease.
Taken together, these data suggest that patients with MM who have a persistent disease after a reduced-intensity Allo-SCT might benefit from a post-transplant maintenance strategy with lenalidomide by a direct anti-tumor effect and a stimulation of the graft versus myeloma effect. The primary objective of this study is to evaluate the safety of such a strategy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| lenalidomide | Experimental | Drug: Lenalidomide |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients aged 18 to 65 years
- Multiple Myeloma in 2nd or 3rd complete or partial response*
- Disease never refractory to lenalidomide
- Lenalidomide treatment ≤ 9 months
- HLA related or unrelated donor (matched 10/10 or mismatched 9/10 HLA-C high resolution level or HLA-DQ high or low resolution level)
Key exclusion criteria (13 listed)
- Stable or progressive disease
- Hypersensitivity to lenalidomide or excipients
- Lenalidomide treatment > 9 months
- Absence of efficient contraception in women or men
- Cardiac insufficiency (ejection fraction < 50% by echocardiography)
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 |
|---|---|---|
| LenalidomideStart between Day+100 and Day+120 post-transplant - Initial dose: 5 mg/day every day In the absence of thrombocytopenia < 75000/mm3 or neutropenia < 1000/mm3 (with or without G-CSF), increase to the upper level than the ongoing one every third month up to the maximal dose of 15 mg/day every day. - Duration * until persistent stringent complete response for 3 months * or progression defined by IMWG criteria12 * or unacceptable toxicity * or one year after transplant | Drug | lenalidomide |
Primary outcome
Safety of lenalidomide
Time frame: 1 year
The main judgement criteria will be the occurrence of adverse events (AE) requiring the definitive interruption of lenalidomide : * Grade 3 or 4 adverse event according to the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 occurring at the lowest dose of lenalidomide or * Steroid-refractory acute (Seattle criteria) or chronic (National Institutes of Health (NIH) criteria) graft versus host disease or * Transplant-related death
8 secondary outcomes
One-year Progression-Free Survival
Time frame: one year
One-year Overall Survival
Time frame: one year
One-year Transplant Related Mortality
Time frame: one year
One-year incidence of Relapse/Progression
Time frame: one year
Incidences of acute and chronic Graft versus Host Disease
Time frame: one year
Immunophenotypic analysis of blood B, T, NK and dendritic cells
Time frame: one year
Chimerism analysis
Time frame: one year
safety of lenalidomide
Time frame: one year
Results and safety
The study was stopped early (reason given: target number of inclusion not reached). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
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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.
Stephane Vigouroux, Dr principal investigator
University Hospital, Bordeaux
Adélaïde DOUSSAU, Dr study chair
University Hospital, Bordeaux
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Lenalidomide in people with Multiple Myeloma, run by University Hospital, Bordeaux 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 7 inclusion and 13 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: stopped early, as of the sponsor's last update on 22 May 2026. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 was stopped early (reason given: target number of inclusion not reached). Results are not available in the source record.
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?
Safety of lenalidomide (time frame: 1 year). 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 22 May 2026.