- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03669445
Study Association of Lenalidomide, Ixazomib, Dexamethasone and Daratumumab in Newly Diagnosed Standard Risk Multiple Myeloma (IFM2018-01)
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Laura BOGDANOVITCH, CRA
- Phone Number: +33 05 61 77 84 37
- Email: laura.bogdanovitch@chu-toulouse.fr
Study Locations
-
-
-
Bordeaux, France
- Not yet recruiting
- CHU Bordeaux
-
Contact:
- Cyrille HULIN
-
Caen, France
- Not yet recruiting
- CHU de Caen
-
Contact:
- Margaret MACRO
-
Dijon, France
- Not yet recruiting
- CHU de Dijon
-
Grenoble, France
- Not yet recruiting
- CHU de Grenoble
-
Contact:
- Clara MARIETTE
-
Lille, France
- Not yet recruiting
- CHRU de Lille
-
Contact:
- Thierry FACON
-
Lyon, France
- Not yet recruiting
- Hospices Civils de Lyon
-
Contact:
- Lionel KARLIN
-
Marseille, France
- Not yet recruiting
- Institut Paoli Calmettes
-
Contact:
- Anne-Marie STOPPA
-
Nancy, France
- Not yet recruiting
- CHRU de Nancy
-
Nantes, France
- Not yet recruiting
- CHU de Nantes
-
Contact:
- Philippe MOREAU
-
Rennes, France
- Not yet recruiting
- CHU de Rennes
-
Contact:
- Martine ESCOFFRE
-
Toulouse, France, 31000
- Recruiting
- University Hosptial toulouse
-
Contact:
- Michel Attal, MD PhD
-
Tours, France
- Not yet recruiting
- CHU de Tours
-
Contact:
- Lotfi BENBOUBKER
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: four drugs combination
21-day cycles induction, then 28-day cycles consolidation and maintenance with Lenalidomide, Ixazomib, and Dexamethasone Plus Daratumumab
|
21-day cycles induction and 28-day cycles consolidation
21-day cycles induction and 28-day cycles consolidation and 28-day cycles maintenance therapy
21-day cycles induction and 28-day cycles consolidation
21-day cycles induction and 28-day cycles consolidation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
minimal residual disease-negativity rate
Time Frame: 22 months
|
after completion of the consolidation therapy and before maintenance
|
22 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall survival
Time Frame: 54 months
|
54 months
|
|
Adverse events
Time Frame: up to 54 Months
|
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
|
up to 54 Months
|
Response rates
Time Frame: 3 months, 5 months, 7 months, 13 months, 25 months
|
Response rates according to the IMWG criteria after induction, high dose Melphalan, consolidation and maintenance therapy
|
3 months, 5 months, 7 months, 13 months, 25 months
|
Progression free survival
Time Frame: 54 months
|
54 months
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Michel ATTAL, MD, University Hospital, Toulouse
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Immunoproliferative Disorders
- Hematologic Diseases
- Hemorrhagic Disorders
- Hemostatic Disorders
- Paraproteinemias
- Blood Protein Disorders
- Multiple Myeloma
- Neoplasms, Plasma Cell
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Anti-Inflammatory Agents
- Antineoplastic Agents
- Immunologic Factors
- Antiemetics
- Gastrointestinal Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Protease Inhibitors
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Dexamethasone
- Lenalidomide
- Daratumumab
- Ixazomib
Other Study ID Numbers
- RC31/18/0212
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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