Multiple MyelomaPhase 2IFM-CRdNCT02405364
Front-line Therapy With Carfilzomib, Lenalidomide, and Dexamethasone Induction
A Phase 2 study testing Carfilzomib/Lenalidomide/Dexamethasone in people with Multiple Myeloma, run by University Hospital, Toulouse at 11 sites in France.
Trial summary
The purpose is to determine whether induction and consolidation treatment with Carfilzomib, Lenalidomide and Dexamethasone (CRd), within an intensive program, warrant further investigation in clinical trials. 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?
- Carfilzomib/Lenalidomide/Dexamethasone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 11 sitesFrance
- Study dates
- Feb 2014to 25 Nov 2019
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with multiple myeloma based on the new International Myeloma Working Group
- Subjects must have symptomatic myeloma with at least one CRAB criteria
- Subjects must not have been treated previously with any systemic therapy for multiple myeloma
Who cannot join
- Pregnant or lactating females
- Evidence of mucosal or internal bleeding and/or platelet refractory
- Acute active infection requiring treatment
- Treatment by localized radiotherapy if the interval between the end of radiotherapy and initiation of protocol therapy lower than 2 weeks
- Treatment by corticosteroids if exceed the equivalent of 160 mg of dexamethasone in a 2-week period before initiation therapy
- Subjects not eligible for high dose therapy
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
France11 sites
CHU Henri Mondor
Créteil
CHRU Dijon
Dijon
CHU Grenoble
Grenoble
Hôpital Claude Huriez
Lille
CHRU Hôtel Dieu
Nantes
Hôpital Saint-Antoine
Paris
Hôpital de Pontchaillou
Rennes
Hôpital de Hautepierre
Strasbourg
CHU de Toulouse
Toulouse, 31000
University hospital of Toulouse
Toulouse, 31000
Hôpital Bretonneau
Tours
About this study
Official title: Front-line Therapy With Carfilzomib, Lenalidomide, and Dexamethasone (CRd) Induction Followed by Autologous Stem Cell Transplantation, CRd Consolidation and Lenalidomide Maintenance in Newly Diagnosed Multiple Myeloma Patients ≤65 Years Old
The purpose is to determine whether induction and consolidation treatment with Carfilzomib, Lenalidomide and Dexamethasone (CRd), within an intensive program, warrant further investigation in clinical trials.
Read the detailed description
The primary objective is to evaluate the sCR rate of the combination of carfilzomib, lenalidomide and dexamethasone in newly diagnosed multiple myeloma patients at the completion of consolidation therapy.
It's a multicenter, open label, non randomized, phase II study. 46 patients will be enrolled.
Induction: 4 cycles of 28 Days with Carfilzomib/Lenalidomide and dexamethasone Stem Cell Harvest: High dose Cyclophosphamide with intensification consolidation: 4 cycles of 28 Days with Carfilzomib/Lenalidomide and dexamethasone Maintenance : Lenalidomide 13 cycles of 28 days
- Conditions
- Multiple Myeloma
- Being tested
- Carfilzomib/Lenalidomide/Dexamethasone
- Keywords
- Multiple Myeloma, Carfilzomib, Lenalidomide, Dexamethasone, Patient up to 65 years, initial management
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carfilzomib/Lenalidomide/DexamethasoneDrug
Also called New drug combination
Induction:Carfilzomib/Lenalidomide/Dexamethasone (4 cycles every 28 days) Stem Cell harvest: HD Cyclophosphamide Intensification: HD Melphalan Consolidation:Carfilzomib/Lenalidomide/Dexamethasone (4 cycles every 28 days) Maintenance: Lenalidomide (13 cycles)
| Study group | Role | What they receive |
|---|---|---|
| Front line therapy | Experimental | Induction: 4 cycles of 28 days of Carfilzomib/Lenalidomide/Dexamethasone Stem Cell Harvest+Intensification Consolidation 4 cycles of 28 days of Carfilzomib/ Lenalidomide/Dexamethasone Maintenance: Lenalidomide 13 cycles of 28 days Receives: Drug: Carfilzomib/Lenalidomide/Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of stringent complete response
completion of consolidation
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2015 (estimated)
- Study startFeb 2014
- Primary completion25 Nov 2019
- Study completion25 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe 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
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Collaborators
- Onyx Therapeutics, Inc., Celgene
- Responsible party
- Sponsor
- Investigators
- Michel ATTAL, MD, Principal investigator, University Hospital of ToulouseMurielle ROUSSEL, MD, Principal investigator, University Hospital of Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02405364
- Sponsor's protocol ID
- 12 568 03
- Acronym
- IFM-CRd
- Status last verified
- Apr 2026
- First submitted
- 16 Oct 2013
- Last updated
- 8 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Roussel M, Lauwers-Cances V, Wuilleme S, Belhadj K, Manier S, Garderet L, Escoffre-Barbe M, Mariette C, Benboubker L, Caillot D, Sonntag C, Touzeau C, Dupuis J, Moreau P, Leleu X, Facon T, Hebraud B, Corre J, Attal M. Up-front carfilzomib, lenalidomide, and dexamethasone with transplant for patients with multiple myeloma: the IFM KRd final results. Blood. 2021 Jul 15;138(2):113-121. doi: 10.1182/blood.2021010744.
PubMed 33827114Landgren O, Kazandjian D, Roussel M, Jasielec J, Dytfeld D, Anderson A, Kervin TA, Iskander K, McFadden I, Jakubowiak AJ. Efficacy and safety of carfilzomib-lenalidomide-dexamethasone in newly diagnosed multiple myeloma: pooled analysis of four single-arm studies. Leuk Lymphoma. 2022 Oct;63(10):2413-2421. doi: 10.1080/10428194.2022.2068001. Epub 2022 May 12.
PubMed 35549810
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Front-line Therapy With Carfilzomib, Lenalidomide, and Dexamethasone (CRd) Induction Followed by Autologous Stem Cell Transplantation, CRd Consolidation and Lenalidomide Maintenance in Newly Diagnosed Multiple Myeloma Patients ≤65 Years Old
- ClinicalTrials.gov ID
- NCT02405364
- Acronym / sponsor ID
- IFM-CRd / 12 568 03
- Conditions
- Multiple Myeloma
- Keywords
- Multiple Myeloma, Carfilzomib, Lenalidomide, Dexamethasone, Patient up to 65 years, initial management
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Collaborators
- Onyx Therapeutics, Inc., Celgene
- Study start
- Feb 2014 (actual)
- Primary completion
- 25 Nov 2019 (actual)
- Study completion
- 25 Nov 2019 (actual)
- First posted
- 1 Apr 2015 (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 is to determine whether induction and consolidation treatment with Carfilzomib, Lenalidomide and Dexamethasone (CRd), within an intensive program, warrant further investigation in clinical trials.
Detailed description
The primary objective is to evaluate the sCR rate of the combination of carfilzomib, lenalidomide and dexamethasone in newly diagnosed multiple myeloma patients at the completion of consolidation therapy.
It's a multicenter, open label, non randomized, phase II study. 46 patients will be enrolled.
Induction: 4 cycles of 28 Days with Carfilzomib/Lenalidomide and dexamethasone Stem Cell Harvest: High dose Cyclophosphamide with intensification consolidation: 4 cycles of 28 Days with Carfilzomib/Lenalidomide and dexamethasone Maintenance : Lenalidomide 13 cycles of 28 days
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Front line therapy | Experimental | Drug: Carfilzomib/Lenalidomide/DexamethasoneInduction: 4 cycles of 28 days of Carfilzomib/Lenalidomide/Dexamethasone Stem Cell Harvest+Intensification Consolidation 4 cycles of 28 days of Carfilzomib/ Lenalidomide/Dexamethasone Maintenance: Lenalidomide 13 cycles of 28 days |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients diagnosed with multiple myeloma based on the new International Myeloma Working Group
- Subjects must have symptomatic myeloma with at least one CRAB criteria
- Subjects must not have been treated previously with any systemic therapy for multiple myeloma
Key exclusion criteria (6 listed)
- Pregnant or lactating females
- Evidence of mucosal or internal bleeding and/or platelet refractory
- Acute active infection requiring treatment
- Treatment by localized radiotherapy if the interval between the end of radiotherapy and initiation of protocol therapy lower than 2 weeks
- Treatment by corticosteroids if exceed the equivalent of 160 mg of dexamethasone in a 2-week period before initiation therapy
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 |
|---|---|---|
| Carfilzomib/Lenalidomide/DexamethasoneAlso: New drug combinationInduction:Carfilzomib/Lenalidomide/Dexamethasone (4 cycles every 28 days) Stem Cell harvest: HD Cyclophosphamide Intensification: HD Melphalan Consolidation:Carfilzomib/Lenalidomide/Dexamethasone (4 cycles every 28 days) Maintenance: Lenalidomide (13 cycles) | Drug | Front line therapy |
Primary outcome
rate of stringent complete response
Time frame: 12 months
completion of consolidation
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 8 Apr 2026.
- Results publication: PubMed 33827114Roussel M, Lauwers-Cances V, Wuilleme S, Belhadj K, Manier S, Garderet L, Escoffre-Barbe M, Mariette C, Benboubker L, Caillot D, Sonntag C, Touzeau C, Dupuis J, Moreau P, Leleu X, Facon T, Hebraud B, Corre J, Attal M. Up-front carfilzomib, lenalidomide, and dexamethasone with transplant for patients with multiple myeloma: the IFM KRd final results. Blood. 2021 Jul 15;138(2):113-121. doi: 10.1182/blood.2021010744.
- Derived from this study: PubMed 35549810Landgren O, Kazandjian D, Roussel M, Jasielec J, Dytfeld D, Anderson A, Kervin TA, Iskander K, McFadden I, Jakubowiak AJ. Efficacy and safety of carfilzomib-lenalidomide-dexamethasone in newly diagnosed multiple myeloma: pooled analysis of four single-arm studies. Leuk Lymphoma. 2022 Oct;63(10):2413-2421. doi: 10.1080/10428194.2022.2068001. Epub 2022 May 12.
- Individual participant dataSharing planned: No
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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.
Michel ATTAL, MD principal investigator
University Hospital of Toulouse
Murielle ROUSSEL, MD principal investigator
University Hospital of Toulouse
11 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 Carfilzomib/Lenalidomide/Dexamethasone in people with Multiple Myeloma, run by University Hospital, Toulouse at 11 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 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 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 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?
rate of stringent complete response (time frame: 12 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 NCT02405364, which also lists 2 linked publications.
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 8 Apr 2026.