Multiple MyelomaPhase 2IFM2014-03NCT02897830
Ixazomib, Lenalidomide, Dexamethasone Induction and Extended Consolidation Plus Lenalidomide Maintenance in Multiple Myeloma
A Phase 2 study testing Ixazomib, Lenalidomide and Dexamethasone in people with Multiple Myeloma, run by University Hospital, Toulouse at 1 site in France.
Trial summary
Open-label study to evaluate the safety and efficacy of Ixazomib in combination with Lenalidomide and Dexamethasone in patients with newly diagnosed multiple myeloma (MM). The patient population will consist of adult men and women up to 65 years, who have a confirmed diagnosis of MM who meet eligibility criteria. 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
- 46 participants
- Where
- 1 siteFrance
- Study dates
- 5 Aug 2016to 31 Aug 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Multiple myeloma based on the new IMWG Diagnostic Criteria for plasma cells disorders
- Symptomatic myeloma with CRAB criteria
- Measurable disease requiring systemic therapy defined by serum M-component ≥ 5g/l or 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.
- Eligibility for high dose therapy.
- Life expectancy ≥ 3 months
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- ECOG performance status 0, 1 or 2
- Patients must meet the following clinical laboratory criteria:
- Adequate hepatic function,
- 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
- Platelet count ≥ 75 × 109/L eRenal eGFR ≥ 50 mL/minute within 7 days
Who cannot join
- Female patients who are both lactating and breastfeeding or have a positive serum pregnancy test during the screening
- 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.
- Corticosteroids if exceed the equivalent of 160 mg of dexamethasone within 14 days before first dose of study drug
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- Central nervous system involvement
- Growth factors within 7 days of screening
- Transfusion within 7 days of screening
- Uncontrolled hypertension or uncontrolled diabetes within 14 days prior to first dose of study drug
- Infection .
- Evidence of current uncontrolled cardiovascular conditions,
- Systemic treatment, within 14 days before first dose of study drug, with strong inhibitors of CYP1A2 , strong inhibitors of CYP3A or use of Ginkgo biloba or St. John's wort.
- Ongoing or active systemic infection, known human immunodeficiency virus (HIV) positive, known active hepatitis B virus hepatitis, or known active hepatitis C virus hepatitis and history of hepatitis B or C virus hepatitis.
- 15. 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,
- Contraindication to any of the required concomitant drugs
- Diagnosed or treated for another malignancy within 5 years before study enrollment or previously diagnosed with another malignancy and have any evidence of residual disease.
- Patient has significant neuropathy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Ixazomib, Lenalidomide, Dexamethasone Induction and Extended Consolidation Followed by Lenalidomide Maintenance in Newly Diagnosed Multiple Myeloma Patients ≤65 Years Eligible for High Dose Therapy
Open-label study to evaluate the safety and efficacy of Ixazomib in combination with Lenalidomide and Dexamethasone in patients with newly diagnosed multiple myeloma (MM). The patient population will consist of adult men and women up to 65 years, who have a confirmed diagnosis of MM who meet eligibility criteria.
Read the detailed description
Patients will receive induction therapy, comprising three cycles with Ixazomib, plus Lenalidomide and Dexamethasone.
Peripheral Blood Stem Cells (PBSC) will be mobilized within 2 weeks (+/- 1 week) after the last dose of Lenalidomide, with Cyclophosphamide plus G-CSF or Granulocyte-CSF(Colony Stimulating Factor).
Intensification: High Dose Melphalan (HDM) will be performed within 3 weeks +/- 1 week following stem cell harvest.
After Peripheral Blood Stem Cell Transplantation, patient will enter in the consolidation phase:
Early consolidation (consolidation part 1) will start 2 months after transplantation and will comprise 2 cycles of MLN - Rd (MLN R identical to induction therapy but low dose of Dexamethasone).
Late consolidation (consolidation part 2) will consist in 6 additional cycles of Ixazomib plus Lenalidomide. No Dexamethasone.
Maintenance therapy will start within 28 days after the last dose of Lenalidomide in last cycle of Late Consolidation for thirteen 28-day cycles (approximately 12 months duration) Patients will be seen at regular treatment cycle intervals while they are participating in the study.
Response will be assessed according to the International Myeloma Working Group (IMWG) criteria until disease progression. All patients will be followed for survival after progression.
- Conditions
- Multiple Myeloma
- Being tested
- Ixazomib, Lenalidomide, 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
Also called MLN 9708
induction therapy: comprising three 28-day cycles with Ixazomib (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.
Early consolidation : (consolidation part 1) will start 2 months (-/+ 14 days) after transplantation and will comprise 2 cycles of MLN - Rd (MLN R identical to induction therapy but low dose of Dexamethasone 20mg/d once a week).
Late consolidation (consolidation part 2) will consist in 6 additional 28-day cycles of Ixazomib (4 mg on Days 1, 8 and 15) plus Lenalidomide (25 mg on Days 1 through 21).
LenalidomideDrug
Also called Revlimid
induction therapy: comprising three 28-day cycles with Ixazomib (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.
Early consolidation : (consolidation part 1) will start 2 months (-/+ 14 days) after transplantation and will comprise 2 cycles of MLN - Rd (MLN R identical to induction therapy but low dose of Dexamethasone 20mg/d once a week).
Late consolidation (consolidation part 2) will consist in 6 additional 28-day cycles of Ixazomib (4 mg on Days 1, 8 and 15) plus Lenalidomide (25 mg on Days 1 through 21).
Maintenance therapy will start within 28 days after the last dose of Lenalidomide in last cycle of Late Consolidation: Lenalidomide 10 mg/d taken on Days 1 through 21 for thirteen 28-day cycles
DexamethasoneDrug
induction therapy: comprising three 28-day cycles with Ixazomib (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.
Early consolidation : (consolidation part 1) will start 2 months (-/+ 14 days) after transplantation and will comprise 2 cycles of MLN - Rd (MLN R identical to induction therapy but low dose of Dexamethasone 20mg/d once a week).
| Study group | Role | What they receive |
|---|---|---|
| Study treatment | Experimental | Ixazomib, Lenalidomide, Dexamethasone Induction and extended Consolidation followed by Lenalidomide Maintenance Receives: Drug: Ixazomib; Drug: Lenalidomide; Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of stringent complete response
after consolidation and before maintenance therapy
Measured: 13 months
Secondary outcomes (7)
Adverse events
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Measured: up 60 Months
response rates
response rates according to the IMWG criteria after induction, high dose Melphalan, early consolidation, late consolidation and maintenance therapy
Measured: 3 months, 5 months, 7 months, 13 months, 25 months
Progression free survival
Measured: 60 months
overall survival
Measured: 60 months
Percentage of patients for whom more than 5X106 CD34 cells will be collected.
At stem cell harvest
Measured: 3 months
Correlation between presence of deletion 17p and response rate
biological prognostic factors assessed at D1 influencing outcome and response rates assessed at 60th month
Measured: 60 months
Correlation between presence of translocation4-14 and response rate
biological prognostic factors assessed at D1 influencing outcome and response rates assessed at 60th month
Measured: 60 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 2016 (estimated)
- Study start5 Aug 2016
- Primary completionNov 2018
- Study completion31 Aug 2020
Why it stopped: negatives results
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
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michel ATTAL, MD, Principal investigator, University Hospital, ToulouseMurielle ROUSSEL, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02897830
- Sponsor's protocol ID
- 14 7261 03
- Acronym
- IFM2014-03
- Status last verified
- Nov 2020
- First submitted
- 17 Jul 2015
- Last updated
- 12 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Ixazomib, Lenalidomide, Dexamethasone Induction and Extended Consolidation Followed by Lenalidomide Maintenance in Newly Diagnosed Multiple Myeloma Patients ≤65 Years Eligible for High Dose Therapy
- ClinicalTrials.gov ID
- NCT02897830
- Acronym / sponsor ID
- IFM2014-03 / 14 7261 03
- Conditions
- Multiple Myeloma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: negatives results
- Enrolment
- 46 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Collaborators
- Takeda, Celgene
- Study start
- 5 Aug 2016 (actual)
- Primary completion
- Nov 2018 (actual)
- Study completion
- 31 Aug 2020 (actual)
- First posted
- 13 Sep 2016 (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.
Open-label study to evaluate the safety and efficacy of Ixazomib in combination with Lenalidomide and Dexamethasone in patients with newly diagnosed multiple myeloma (MM). The patient population will consist of adult men and women up to 65 years, who have a confirmed diagnosis of MM who meet eligibility criteria.
Detailed description
Patients will receive induction therapy, comprising three cycles with Ixazomib, plus Lenalidomide and Dexamethasone.
Peripheral Blood Stem Cells (PBSC) will be mobilized within 2 weeks (+/- 1 week) after the last dose of Lenalidomide, with Cyclophosphamide plus G-CSF or Granulocyte-CSF(Colony Stimulating Factor).
Intensification: High Dose Melphalan (HDM) will be performed within 3 weeks +/- 1 week following stem cell harvest.
After Peripheral Blood Stem Cell Transplantation, patient will enter in the consolidation phase:
Early consolidation (consolidation part 1) will start 2 months after transplantation and will comprise 2 cycles of MLN - Rd (MLN R identical to induction therapy but low dose of Dexamethasone).
Late consolidation (consolidation part 2) will consist in 6 additional cycles of Ixazomib plus Lenalidomide. No Dexamethasone.
Maintenance therapy will start within 28 days after the last dose of Lenalidomide in last cycle of Late Consolidation for thirteen 28-day cycles (approximately 12 months duration) Patients will be seen at regular treatment cycle intervals while they are participating in the study.
Response will be assessed according to the International Myeloma Working Group (IMWG) criteria until disease progression. 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 |
|---|---|---|
| Study treatment | Experimental | Drug: Ixazomib, Drug: Lenalidomide, Drug: DexamethasoneIxazomib, Lenalidomide, Dexamethasone Induction and extended Consolidation followed by Lenalidomide Maintenance |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Multiple myeloma based on the new IMWG Diagnostic Criteria for plasma cells disorders
- Symptomatic myeloma with CRAB criteria
- Measurable disease requiring systemic therapy defined by serum M-component ≥ 5g/l or 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.
- Eligibility for high dose therapy.
Key exclusion criteria (20 listed)
- Female patients who are both lactating and breastfeeding or have a positive serum pregnancy test during the screening
- 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.
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 |
|---|---|---|
| IxazomibAlso: MLN 9708induction therapy: comprising three 28-day cycles with Ixazomib (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. Early consolidation : (consolidation part 1) will start 2 months (-/+ 14 days) after transplantation and will comprise 2 cycles of MLN - Rd (MLN R identical to induction therapy but low dose of Dexamethasone 20mg/d once a week). Late consolidation (consolidation part 2) will consist in 6 additional 28-day cycles of Ixazomib (4 mg on Days 1, 8 and 15) plus Lenalidomide (25 mg on Days 1 through 21). | Drug | Study treatment |
| LenalidomideAlso: Revlimidinduction therapy: comprising three 28-day cycles with Ixazomib (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. Early consolidation : (consolidation part 1) will start 2 months (-/+ 14 days) after transplantation and will comprise 2 cycles of MLN - Rd (MLN R identical to induction therapy but low dose of Dexamethasone 20mg/d once a week). Late consolidation (consolidation part 2) will consist in 6 additional 28-day cycles of Ixazomib (4 mg on Days 1, 8 and 15) plus Lenalidomide (25 mg on Days 1 through 21). Maintenance therapy will start within 28 days after the last dose of Lenalidomide in last cycle of Late Consolidation: Lenalidomide 10 mg/d taken on Days 1 through 21 for thirteen 28-day cycles | Drug | Study treatment |
| Dexamethasoneinduction therapy: comprising three 28-day cycles with Ixazomib (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. Early consolidation : (consolidation part 1) will start 2 months (-/+ 14 days) after transplantation and will comprise 2 cycles of MLN - Rd (MLN R identical to induction therapy but low dose of Dexamethasone 20mg/d once a week). | Drug | Study treatment |
Primary outcome
rate of stringent complete response
Time frame: 13 months
after consolidation and before maintenance therapy
7 secondary outcomes
Adverse events
Time frame: up 60 Months
response rates
Time frame: 3 months, 5 months, 7 months, 13 months, 25 months
Progression free survival
Time frame: 60 months
overall survival
Time frame: 60 months
Percentage of patients for whom more than 5X106 CD34 cells will be collected.
Time frame: 3 months
Correlation between presence of deletion 17p and response rate
Time frame: 60 months
Correlation between presence of translocation4-14 and response rate
Time frame: 60 months
Results and safety
The study was stopped early (reason given: negatives results). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2020.
- 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, Toulouse
Murielle ROUSSEL, MD principal investigator
University Hospital, Toulouse
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 Ixazomib, Lenalidomide and Dexamethasone in people with Multiple Myeloma, run by University Hospital, Toulouse 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 12 inclusion and 20 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 12 Nov 2020. 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 was stopped early (reason given: negatives results). 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?
rate of stringent complete response (time frame: 13 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 12 Nov 2020.