Newly Diagnosed Multiple MyelomaPhase 2IFM2013-06NCT01936532
Safety and Efficacy Study of a Triplet Combination of MLN9708, Lenalidomide and Dexamethasone in the Initial Management of Multiple Myeloma (IFM2013-06)
A Phase 2 study testing MLN9708, Lenalidomide and Dexamethasone in people with Newly Diagnosed Multiple Myeloma, run by Nantes University Hospital at 10 sites in France.
Trial summary
This is a phase II, multicenter, open-label study to evaluate the safety and efficacy of MLN9708 in combination with Lenalidomide and Dexamethasone in patients with newly diagnosed multiple myeloma. Read more about this study
- Who is it for?
- Ages 18 to 66 years
- Conditions the study is for
- Newly Diagnosed Multiple Myeloma
- What is being tested?
- MLN9708, Lenalidomide and Dexamethasone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 10 sitesFrance
- Study dates
- 12 Nov 2014to 4 Jun 2020
- 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 to 66 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients ≥ 18 years and ≤ 65 years at the time
- Voluntary written consent must be given before performance of any study related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care.
- Patients diagnosed with multiple myeloma
- Subjects must have symptomatic myeloma with CRAB criteria.
- Subjects must have measurable disease requiring systemic therapy defined by serum M-component ≥ 5g/l, urine M-component ≥ 200 mg/24h or serum FLC ≥ 100 mg/l.
- Subjects must not have been treated previously with any systemic therapy for multiple myeloma. 7.Subjects must be eligible for high dose therapy.
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- 8.Life expectancy ≥ 3 months.9.ECOG performance status 0, 1 or 2. 10.Patients must meet the following clinical laboratory criteria
- Adequate hepatic function, with serum ALT and AST ≤ 3 times the upper limit of normal and serum direct bilirubin ≤ 1.5 times the upper limit of normal within 14 days prior to enrolment.
- Absolute neutrophil count (ANC) ≥ 1.0 × 109/L within 14 days prior to enrollment.
- Hemoglobin ≥ 8 g/dL (80 g/L) within 14 days prior to enrollment (subjects may be receiving red blood cell [RBC] transfusions in accordance with institutional guidelines with a wash-out period of 7 days).
- Platelet count ≥ 75 × 109/L (≥ 30 × 109/L if myeloma involvement in the bone marrow is > 50%) within 14 days prior to enrollment. Platelet transfusions to help patients meet eligibility criteria are not allowed within 3 days before study enrollment.
- Calculated creatinine clearance ≥ 30 mL/minute (MDRD formula should be used for calculating creatinine clearance values: http://mdrd.com/).
- 11.Female of childbearing potential:must have two negative pregnancy tests : one serum pregnancy test within 10 to 14 days prior to therapy and one urine pregnancy test within 24 hours before starting study drug.
- must agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent through 3 months after the last dose of study drug, or agree to completely abstain from heterosexual intercourse.
- 12.Male patients, even if surgically sterilized, must agree to not father a child and agree to use a latex condom during therapy and for 3 months after the last dose of study drug, even if they have had a successful vasectomy, if their partner is of childbearing potential.
- 13.Affiliation number to National Health Care System.
Who cannot join
- Female patients who are both lactating and breastfeeding or have a positive serum pregnancy test during the screening period or a positive urine pregnancy test within 24 hours before first dose of study drug.
- Evidence of mucosal or internal bleeding and/or platelet refractory.
- Prior myeloma systemic therapy.
- Major surgery within 14 days before first dose of study drug.
- Radiotherapy within 14 days before first dose of study drug. If the involved field is small, 7 days will be considered a sufficient interval between treatment and administration of the MLN9708.
- Treatment by corticosteroids if exceed the equivalent of 160 mg of dexamethasone within 14 days before first dose of study drug.
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- Subjects not eligible for high dose therapy.
- Growth factors within 7 days prior to enrolment.
- Transfusion within 3 days prior to enrolment.
- Uncontrolled hypertension or uncontrolled diabetes within 14 days prior to first dose of study drug.
- Infection requiring systemic antibiotic therapy or other serious infection within 14 days before first dose of study drug.
- Evidence of current uncontrolled cardiovascular conditions, including uncontrolled hypertension, uncontrolled cardiac arrhythmias, symptomatic congestive heart failure, unstable angina, or myocardial infarction within 6 months.
- Systemic treatment, within 14 days before first dose of study drug, with strong inhibitors of CYP1A2, strong inhibitors of CYP3A or strong CYP3A inducers, or use of Ginkgo biloba or St. John's wort.
- Ongoing or active systemic infection, known human immunodeficiency virus positive, known active hepatitis B virus hepatitis, or known active hepatitis C virus hepatitis.
- Co-morbid systemic illnesses or other severe concurrent disease that, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens.
- Psychiatric illness/social situation that would limit compliance with study requirements.
- Known allergy to any of the study medications, their analogues, or excipients in the various formulations of any agent.
- Contraindication to any of the required concomitant drugs or supportive treatments, including hypersensitivity to all anticoagulation and antiplatelet options, antiviral drugs, or intolerance to hydration due to preexisting pulmonary or cardiac impairment.
- Inability to swallow oral medication, inability or unwillingness to comply with the drug administration requirements, or GI procedure that could interfere with the oral absorption or tolerance of treatment.
- Diagnosed or treated for another malignancy within 2 years before study enrollment or previously diagnosed with another malignancy and have any evidence of residual disease. Patients with nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection.
- Patient has significant neuropathy within 14 days prior to enrolment.
- Subjects with pleural effusions requiring thoracentesis or ascites requiring paracentesis within 14 days prior to enrolment.
- Any other clinically significant medical disease or condition that, in the Investigator's opinion, may interfere with protocol adherence or a subject's ability to give informed consent.
- Participation in clinical trials with other investigational agents not included in this trial, within 21days of the start of this trial and throughout the duration of this trial.
- Failure to have fully recovered from the reversible effects of prior chemotherapy.
- Central nervous system involvement
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
France10 sites
CHRU - Hôpital du Haut Lévêque
Bordeaux, 33604
CHRU Dijon
Dijon, 21000
Centre hospitalier départemental Vendée
La Roche-sur-Yon, 85925
CHRU - Hôpital Claude Huriez
Lille, 59037
Nantes University Hospital
Nantes, 44093
Hôpital Saint-Antoine
Paris, 75 571
Centre Hospitalier Lyon sud
Pierre-Bénite, 69495
Pole IUC Oncopole CHU
Toulouse, 31059
CHRU - Hôpital Bretonneau
Tours, 37044
CHRU - Hôpitaux de Brabois
Vandœuvre-lès-Nancy, 54511
About this study
Official title: Phase II Trial Studying the Efficacy of a Triplet Combination of MLN9708, Lenalidomide and Dexamethasone as Induction Prior to, and as Consolidation After High-dose Therapy With Peripheral Stem Cell Transplantation Followed by MLN9708 Maintenance in the Initial Management of Multiple Myeloma in Patients Younger Than 66 Years
This is a phase II, multicenter, open-label study to evaluate the safety and efficacy of MLN9708 in combination with Lenalidomide and Dexamethasone in patients with newly diagnosed multiple myeloma. The patient population will consist of adult men and women younger than 66 years, who have a confirmed diagnosis of MM who meet eligibility criteria.
Following the screening period, patients will be enrolled and treated then, they will receive induction therapy (3 cycles), a systematic Peripheral Blood Stem Cell harvest. After Peripheral Blood Stem Cell Transplantation, patient will enter in the consolidation phase (early and late one) 2 months after transplantation. Finally, patients follow a Maintenance therapy (start 1 month after the last cycle of consolidation) during 12 months.
- Conditions
- Newly Diagnosed Multiple Myeloma
- Being tested
- MLN9708, Lenalidomide, Dexamethasone
- Keywords
- multiple myeloma
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MLN9708Drug
Induction therapy Patients will receive 3 cycles of induction therapy with MLN9708 (4 mg) on Days 1, 8 and 15, plus Lenalidomide (25 mg) on Days 1 through 21 and Dexamethasone (40 mg) on Days 1, 8, 15 and 22 of a 28-day cycle.
Consolidation therapy
- Early consolidation (consolidation part 1) will comprise 2 cycles of MRD identical to induction therapy.
- Late consolidation (consolidation part 2) will consist in 6 additional cycles of MLN9708 (4 mg on Days 1, 8 and 15) plus lenalidomide (25 mg on Days 1 through 21) of a 28-day cycle.
Maintenance therapy MLN9708 monotherapy (4 mg/day), will be given on days 1, 8 and 15 of a 28 day cycle, during 12 months.
LenalidomideDrug
DexamethasoneDrug
| Study group | Role | What they receive |
|---|---|---|
| assessment of treatment lenalidomide, dexamethasone,MLN9708 | Experimental | Not described Receives: Drug: MLN9708; Drug: Lenalidomide; Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the stringent Complete Response (sCR) rate of the combination of MLN9708, Lenalidomide and Dexamethasone in newly diagnosed multiple myeloma (MM) patients after extended consolidation therapy
Measured: sixteen months
Secondary outcomes (7)
To evaluate the overall response rate after induction therapy
Measured: after 63 days
To evaluate the safety Evaluate the safety
Descriptive statistics of treatment duration cumulative dose, dose intensity and relative dose intensity will be presented.
Treatment emergent adverse events will be summarized by period (induction, consolidation and maintenance) and overall.
Overall adverse events will be summarized by system organ class and preferred term and by severity (worst toxicity grade owing to the NCI CTCAE v4.0).
Measured: after 63 days
To evaluate the quality of stem cell harvest
according to institutional practice, participants must collect a minimum CD34 count of > 5x106 cells/kg. In case of insufficient collection, collection of a minimum CD34 count of > 2x106 cells/kg will be allowed.
Thus the number of cells collected will be evaluated
Measured: after 84 days
To evaluate the overall response rate after high-dose therapy (prior to consolidation)
Measured: after 84 days
To evaluate the overall response rate after consolidation therapy
Measured: after 270 days
To evaluate the feasibility of maintenance with MLN9708
number of dose
Measured: after 270 days
To evaluate duration of response, progression-free and overall survival
Measured: five years and a half
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2013 (estimated)
- Study start12 Nov 2014
- Primary completionMar 2019
- Study completion4 Jun 2020
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 Newly Diagnosed Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by Nantes 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philippe MOREAU, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01936532
- Sponsor's protocol ID
- RC12_0447
- Other IDs
- 2013-001443-31
- Acronym
- IFM2013-06
- Status last verified
- Aug 2023
- First submitted
- 29 Jul 2013
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Touzeau C, Perrot A, Roussel M, Karlin L, Benboubker L, Jacquet C, Mohty M, Facon T, Manier S, Chretien ML, Tiab M, Hulin C, Leleu X, Loiseau HA, Dejoie T, Planche L, Attal M, Moreau P. All-oral triplet combination of ixazomib, lenalidomide, and dexamethasone in newly diagnosed transplant-eligible multiple myeloma patients: final results of the phase II IFM 2013-06 study. Haematologica. 2022 Jul 1;107(7):1693-1697. doi: 10.3324/haematol.2021.280394. No abstract available.
PubMed 35172566
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial Studying the Efficacy of a Triplet Combination of MLN9708, Lenalidomide and Dexamethasone as Induction Prior to, and as Consolidation After High-dose Therapy With Peripheral Stem Cell Transplantation Followed by MLN9708 Maintenance in the Initial Management of Multiple Myeloma in Patients Younger Than 66 Years
- ClinicalTrials.gov ID
- NCT01936532
- Acronym / sponsor ID
- IFM2013-06 / RC12_0447
- Conditions
- Newly Diagnosed Multiple Myeloma
- Keywords
- multiple myeloma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 12 Nov 2014 (actual)
- Primary completion
- Mar 2019 (actual)
- Study completion
- 4 Jun 2020 (actual)
- First posted
- 6 Sep 2013 (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.
This is a phase II, multicenter, open-label study to evaluate the safety and efficacy of MLN9708 in combination with Lenalidomide and Dexamethasone in patients with newly diagnosed multiple myeloma. The patient population will consist of adult men and women younger than 66 years, who have a confirmed diagnosis of MM who meet eligibility criteria.
Following the screening period, patients will be enrolled and treated then, they will receive induction therapy (3 cycles), a systematic Peripheral Blood Stem Cell harvest. After Peripheral Blood Stem Cell Transplantation, patient will enter in the consolidation phase (early and late one) 2 months after transplantation. Finally, patients follow a Maintenance therapy (start 1 month after the last cycle of consolidation) during 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| assessment of treatment lenalidomide, dexamethasone,MLN9708 | Experimental | Drug: MLN9708, Drug: Lenalidomide, Drug: Dexamethasone |
Who may qualify
- Ages
- 18 to 66 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Male or female patients ≥ 18 years and ≤ 65 years at the time
- Voluntary written consent must be given before performance of any study related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care.
- Patients diagnosed with multiple myeloma
- Subjects must have symptomatic myeloma with CRAB criteria.
- Subjects must have measurable disease requiring systemic therapy defined by serum M-component ≥ 5g/l, urine M-component ≥ 200 mg/24h or serum FLC ≥ 100 mg/l.
Key exclusion criteria (26 listed)
- Female patients who are both lactating and breastfeeding or have a positive serum pregnancy test during the screening period or a positive urine pregnancy test within 24 hours before first dose of study drug.
- Evidence of mucosal or internal bleeding and/or platelet refractory.
- Prior myeloma systemic therapy.
- Major surgery within 14 days before first dose of study drug.
- Radiotherapy within 14 days before first dose of study drug. If the involved field is small, 7 days will be considered a sufficient interval between treatment and administration of the MLN9708.
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 |
|---|---|---|
| MLN9708Induction therapy Patients will receive 3 cycles of induction therapy with MLN9708 (4 mg) on Days 1, 8 and 15, plus Lenalidomide (25 mg) on Days 1 through 21 and Dexamethasone (40 mg) on Days 1, 8, 15 and 22 of a 28-day cycle. Consolidation therapy * Early consolidation (consolidation part 1) will comprise 2 cycles of MRD identical to induction therapy. * Late consolidation (consolidation part 2) will consist in 6 additional cycles of MLN9708 (4 mg on Days 1, 8 and 15) plus lenalidomide (25 mg on Days 1 through 21) of a 28-day cycle. Maintenance therapy MLN9708 monotherapy (4 mg/day), will be given on days 1, 8 and 15 of a 28 day cycle, during 12 months. | Drug | assessment of treatment lenalidomide, dexamethasone,MLN9708 |
| Lenalidomide | Drug | assessment of treatment lenalidomide, dexamethasone,MLN9708 |
| Dexamethasone | Drug | assessment of treatment lenalidomide, dexamethasone,MLN9708 |
Primary outcome
To evaluate the stringent Complete Response (sCR) rate of the combination of MLN9708, Lenalidomide and Dexamethasone in newly diagnosed multiple myeloma (MM) patients after extended consolidation therapy
Time frame: sixteen months
7 secondary outcomes
To evaluate the overall response rate after induction therapy
Time frame: after 63 days
To evaluate the safety Evaluate the safety
Time frame: after 63 days
To evaluate the quality of stem cell harvest
Time frame: after 84 days
To evaluate the overall response rate after high-dose therapy (prior to consolidation)
Time frame: after 84 days
To evaluate the overall response rate after consolidation therapy
Time frame: after 270 days
To evaluate the feasibility of maintenance with MLN9708
Time frame: after 270 days
To evaluate duration of response, progression-free and overall survival
Time frame: five years and a half
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 14 Sep 2026.
- Results publication: PubMed 35172566Touzeau C, Perrot A, Roussel M, Karlin L, Benboubker L, Jacquet C, Mohty M, Facon T, Manier S, Chretien ML, Tiab M, Hulin C, Leleu X, Loiseau HA, Dejoie T, Planche L, Attal M, Moreau P. All-oral triplet combination of ixazomib, lenalidomide, and dexamethasone in newly diagnosed transplant-eligible multiple myeloma patients: final results of the phase II IFM 2013-06 study. Haematologica. 2022 Jul 1;107(7):1693-1697. doi: 10.3324/haematol.2021.280394. No abstract available.
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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.
Philippe MOREAU principal investigator
Nantes University Hospital
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MLN9708, Lenalidomide and Dexamethasone in people with Newly Diagnosed Multiple Myeloma, run by Nantes University Hospital at 10 sites 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 16 inclusion and 26 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 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites 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.
What does the primary outcome measure?
To evaluate the stringent Complete Response (sCR) rate of the combination of MLN9708, Lenalidomide and Dexamethasone in newly diagnosed multiple myeloma (MM) patients after extended consolidation therapy (time frame: sixteen months). 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 NCT01936532, 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 14 Sep 2026.