Multiple MyelomaPhase 2IFM2018-01NCT03669445
Study Association of Lenalidomide, Ixazomib, Dexamethasone and Daratumumab in Newly Diagnosed Standard Risk Multiple Myeloma
A Phase 2 study testing Ixazomib, Lenalidomide and Dexamethasone in people with Multiple Myeloma, run by University Hospital, Toulouse at 12 sites in France.
Trial summary
The main objective of this study is to evaluate the minimal residual disease-negativity rate after administration of the combination of Lenalidomide, Ixazomib, Dexamethasone and Daratumumab as induction and consolidation therapy in an intensive program in newly diagnosed standard risk multiple myeloma patients. 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?
- Ixazomib, Lenalidomide and Dexamethasone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 12 sitesFrance
- Study dates
- 31 Dec 2018to Dec 2024
- 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
- De novo symptomatic myeloma on the International Myeloma Working Group Diagnostic Criteria for the Diagnosis of Multiple Myeloma
- Measurable disease requiring systemic therapy defined by serum M-component ≥ 10g/l or urine M-component ≥ 200 mg/24h or involved free light level ≥ 100 mg/l
- Eastern Cooperative Oncology Group performance status 0, 1 or 2
- Eligible to high dose therapy
Who cannot join
- Previously treated with any systemic therapy for multiple myeloma
- Clinical signs of central nervous system involvement
- Renal insufficiency defined as estimated Glomerular Filtration Rate lower or equal to 40 ml/min/1.73 m2
- Hepatic impairment defined as aspartate transminase or alanine transaminase greater or equal to 3 x upper limit of normal, or Total bilirubin greater or equal to 3 x upper limit of normal
- Platelet count < 75,000 per µL
- Absolute neutrophil count ≤ 1,000 cells/mm3
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- Evidence of current uncontrolled cardiovascular conditions
- Female patients who are both lactating and breastfeeding or have a positive serum pregnancy test during the screening
- Infection requiring systemic antibiotic therapy or other serious infection within 14 days before first dose of study drug
- Grade 3 or higher peripheral neuropathy, or grade 2 with pain, on clinical examination during the screening period
- Known or suspected chronic obstructive pulmonary disease with a Forced Expiratory Volume in 1 second < 50% of predicted normal
- Systemic treatment with strong CYP3A inducers (rifampin, rifapentine, rifabutin, carbamazepine, phenytoin, phenobarbital), or use of St. John's wort within 14 days before initiation of the study drug
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
France12 sites, 12 recruiting
- Not yet recruiting
CHU Bordeaux
Bordeaux
Cyrille HULIN
- Not yet recruiting
CHU de Caen
Caen
Margaret MACRO
- Not yet recruiting
CHU de Dijon
Dijon
Denis CAILLOT
- Not yet recruiting
CHU de Grenoble
Grenoble
Clara MARIETTE
- Not yet recruiting
CHRU de Lille
Lille
Thierry FACON
- Not yet recruiting
Hospices Civils de Lyon
Lyon
Lionel KARLIN
- Not yet recruiting
Institut Paoli Calmettes
Marseille
Anne-Marie STOPPA
- Not yet recruiting
CHRU de Nancy
Nancy
Aurore PERROT
- Not yet recruiting
CHU de Nantes
Nantes
Philippe MOREAU
- Not yet recruiting
CHU de Rennes
Rennes
Martine ESCOFFRE
- Recruiting
University Hosptial Toulouse
Toulouse, 31000
Michel Attal, MD PhD
- Not yet recruiting
CHU de Tours
Tours
Lotfi BENBOUBKER
About this study
Official title: Toward a Risk-adapted Strategy to Cure Myeloma : An Intensive Program With Lenalidomide, Ixazomib, and Dexamethasone Plus Daratumumab as Extended Induction and Consolidation Followed by Lenalidomide Maintenance in Newly Diagnosed Standard Risk Multiple Myeloma Patients Eligible for Autologous Stem Cell Transplant : a Phase II Study of the Intergroupe Francophone du Myélome (IFM)
The main objective of this study is to evaluate the minimal residual disease-negativity rate after administration of the combination of Lenalidomide, Ixazomib, Dexamethasone and Daratumumab as induction and consolidation therapy in an intensive program in newly diagnosed standard risk multiple myeloma patients.
For the induction therapy, each patient received 6 cycles of Lenalidomide, Ixazomib, Dexamethasone and Daratumumab, then peripheral blood stem cell harvest, intensification with autologous stem cell transplantation, consolidation therapy and maintenance.
Read the detailed description
This is a phase II, multicenter, non-randomized, open-label study to evaluate the safety and efficacy of Lenalidomide, Ixazomib, Dexamethasone, and Daratumumab in patients with newly diagnosed multiple myeloma.
The patient population will consist of adult men and women ≤ 65 years, who have a confirmed diagnosis of standard risk multiple myeloma, who meet eligibility criteria.
Treatment periods will be defined as 21-day cycles for induction, and 28-day cycles for consolidation, and maintenance. Patients will be seen at regular treatment cycle intervals while they are participating in the study.
Patients will be assessed for disease response and progression according to the International Myeloma Working Group criteria at each cycle during induction and consolidation and every other cycle during maintenance.
Eastern Cooperative Oncology Group performance status, adverse events, laboratory values, and vital sign measurements will be collected and assessed to evaluate the safety of therapy throughout the study.
Toxicity will be evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events. Patients will attend an End of Treatment visit after receiving their last dose of study drug and will continue to be followed for other follow-up assessments specified in the Schedule of events.
All patients will be followed for survival after progression.
- Conditions
- Multiple Myeloma
- Being tested
- Ixazomib, Lenalidomide, Dexamethasone, Daratumumab
- Keywords
- Newly Diagnosed Multiple myeloma, Daratumumab, Lenalidomide, Ixazomib, Dexamethasone
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IxazomibDrug
21-day cycles induction and 28-day cycles consolidation
LenalidomideDrug
21-day cycles induction and 28-day cycles consolidation and 28-day cycles maintenance therapy
DexamethasoneDrug
21-day cycles induction and 28-day cycles consolidation
DaratumumabDrug
21-day cycles induction and 28-day cycles consolidation
| Study group | Role | What they receive |
|---|---|---|
| four drugs combination | Experimental | 21-day cycles induction, then 28-day cycles consolidation and maintenance with Lenalidomide, Ixazomib, and Dexamethasone Plus Daratumumab Receives: Drug: Ixazomib; Drug: Lenalidomide; Drug: Dexamethasone; Drug: Daratumumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
minimal residual disease-negativity rate
after completion of the consolidation therapy and before maintenance
Measured: 22 months
Secondary outcomes (4)
Adverse events
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Measured: up to 54 Months
Response rates
Response rates according to the IMWG criteria after induction, high dose Melphalan, consolidation and maintenance therapy
Measured: 3 months, 5 months, 7 months, 13 months, 25 months
Progression free survival
Measured: 54 months
Overall survival
Measured: 54 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2018
- Study start31 Dec 2018
- Primary completionMar 2024 (estimated)
- Study completionDec 2024 (estimated)
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, 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
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michel ATTAL, MD, Study director, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03669445
- Sponsor's protocol ID
- RC31/18/0212
- Acronym
- IFM2018-01
- Status last verified
- Jul 2020
- First submitted
- 11 Sep 2018
- Last updated
- 30 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Toward a Risk-adapted Strategy to Cure Myeloma : An Intensive Program With Lenalidomide, Ixazomib, and Dexamethasone Plus Daratumumab as Extended Induction and Consolidation Followed by Lenalidomide Maintenance in Newly Diagnosed Standard Risk Multiple Myeloma Patients Eligible for Autologous Stem Cell Transplant : a Phase II Study of the Intergroupe Francophone du Myélome (IFM)
- ClinicalTrials.gov ID
- NCT03669445
- Acronym / sponsor ID
- IFM2018-01 / RC31/18/0212
- Conditions
- Multiple Myeloma
- Keywords
- Newly Diagnosed Multiple myeloma, Daratumumab, Lenalidomide, Ixazomib, Dexamethasone
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 31 Dec 2018 (actual)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 13 Sep 2018 (actual)
- 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 main objective of this study is to evaluate the minimal residual disease-negativity rate after administration of the combination of Lenalidomide, Ixazomib, Dexamethasone and Daratumumab as induction and consolidation therapy in an intensive program in newly diagnosed standard risk multiple myeloma patients.
For the induction therapy, each patient received 6 cycles of Lenalidomide, Ixazomib, Dexamethasone and Daratumumab, then peripheral blood stem cell harvest, intensification with autologous stem cell transplantation, consolidation therapy and maintenance.
Detailed description
This is a phase II, multicenter, non-randomized, open-label study to evaluate the safety and efficacy of Lenalidomide, Ixazomib, Dexamethasone, and Daratumumab in patients with newly diagnosed multiple myeloma.
The patient population will consist of adult men and women ≤ 65 years, who have a confirmed diagnosis of standard risk multiple myeloma, who meet eligibility criteria.
Treatment periods will be defined as 21-day cycles for induction, and 28-day cycles for consolidation, and maintenance. Patients will be seen at regular treatment cycle intervals while they are participating in the study.
Patients will be assessed for disease response and progression according to the International Myeloma Working Group criteria at each cycle during induction and consolidation and every other cycle during maintenance.
Eastern Cooperative Oncology Group performance status, adverse events, laboratory values, and vital sign measurements will be collected and assessed to evaluate the safety of therapy throughout the study.
Toxicity will be evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events. Patients will attend an End of Treatment visit after receiving their last dose of study drug and will continue to be followed for other follow-up assessments specified in the Schedule of events.
All patients will be followed for survival after progression.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| four drugs combination | Experimental | Drug: Ixazomib, Drug: Lenalidomide, Drug: Dexamethasone, Drug: Daratumumab21-day cycles induction, then 28-day cycles consolidation and maintenance with Lenalidomide, Ixazomib, and Dexamethasone Plus Daratumumab |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- De novo symptomatic myeloma on the International Myeloma Working Group Diagnostic Criteria for the Diagnosis of Multiple Myeloma
- Measurable disease requiring systemic therapy defined by serum M-component ≥ 10g/l or urine M-component ≥ 200 mg/24h or involved free light level ≥ 100 mg/l
- Eastern Cooperative Oncology Group performance status 0, 1 or 2
- Eligible to high dose therapy
Key exclusion criteria (12 listed)
- Previously treated with any systemic therapy for multiple myeloma
- Clinical signs of central nervous system involvement
- Renal insufficiency defined as estimated Glomerular Filtration Rate lower or equal to 40 ml/min/1.73 m2
- Hepatic impairment defined as aspartate transminase or alanine transaminase greater or equal to 3 x upper limit of normal, or Total bilirubin greater or equal to 3 x upper limit of normal
- Platelet count < 75,000 per µL
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 |
|---|---|---|
| Ixazomib21-day cycles induction and 28-day cycles consolidation | Drug | four drugs combination |
| Lenalidomide21-day cycles induction and 28-day cycles consolidation and 28-day cycles maintenance therapy | Drug | four drugs combination |
| Dexamethasone21-day cycles induction and 28-day cycles consolidation | Drug | four drugs combination |
| Daratumumab21-day cycles induction and 28-day cycles consolidation | Drug | four drugs combination |
Primary outcome
minimal residual disease-negativity rate
Time frame: 22 months
after completion of the consolidation therapy and before maintenance
4 secondary outcomes
Adverse events
Time frame: up to 54 Months
Response rates
Time frame: 3 months, 5 months, 7 months, 13 months, 25 months
Progression free survival
Time frame: 54 months
Overall survival
Time frame: 54 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2020.
- Individual participant dataSharing planned: Undecided
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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 study director
University Hospital, Toulouse
12 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 Ixazomib, Lenalidomide and Dexamethasone in people with Multiple Myeloma, run by University Hospital, Toulouse at 12 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 4 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 30 Jul 2020. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Laura BOGDANOVITCH, CRA (05 61 77 84 37 ext. +33, laura.bogdanovitch@chu-toulouse.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
minimal residual disease-negativity rate (time frame: 22 months). 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 30 Jul 2020.