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Study Association of Lenalidomide, Ixazomib, Dexamethasone and Daratumumab in Newly Diagnosed Standard Risk Multiple Myeloma (IFM2018-01)

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ClinicalTrials.gov Identifier: NCT03669445
Recruitment Status : Recruiting
First Posted : September 13, 2018
Last Update Posted : February 4, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse

Brief 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.

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.


Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: Ixazomib Drug: Lenalidomide Drug: Dexamethasone Drug: Daratumumab Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : December 31, 2018
Estimated Primary Completion Date : March 2024
Estimated Study Completion Date : December 2024


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
Drug: Ixazomib
21-day cycles induction and 28-day cycles consolidation

Drug: Lenalidomide
21-day cycles induction and 28-day cycles consolidation and 28-day cycles maintenance therapy

Drug: Dexamethasone
21-day cycles induction and 28-day cycles consolidation

Drug: Daratumumab
21-day cycles induction and 28-day cycles consolidation




Primary Outcome Measures :
  1. minimal residual disease-negativity rate [ Time Frame: 22 months ]
    after completion of the consolidation therapy and before maintenance


Secondary Outcome Measures :
  1. Adverse events [ Time Frame: up to 54 Months ]
    Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

  2. 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. Progression free survival [ Time Frame: 54 months ]
  4. Overall survival [ Time Frame: 54 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03669445


Contacts
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Contact: Laura BOGDANOVITCH, CRA 05 61 77 84 37 ext +33 laura.bogdanovitch@chu-toulouse.fr

Locations
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France
CHU Bordeaux Not yet recruiting
Bordeaux, France
Contact: Cyrille HULIN         
CHU de Caen Not yet recruiting
Caen, France
Contact: Margaret MACRO         
CHU de Dijon Not yet recruiting
Dijon, France
Contact: Denis CAILLOT         
CHU de Grenoble Not yet recruiting
Grenoble, France
Contact: Clara MARIETTE         
CHRU de Lille Not yet recruiting
Lille, France
Contact: Thierry FACON         
Hospices Civils de Lyon Not yet recruiting
Lyon, France
Contact: Lionel KARLIN         
Institut Paoli Calmettes Not yet recruiting
Marseille, France
Contact: Anne-Marie STOPPA         
CHRU de Nancy Not yet recruiting
Nancy, France
Contact: Aurore PERROT         
CHU de Nantes Not yet recruiting
Nantes, France
Contact: Philippe MOREAU         
CHU de Rennes Not yet recruiting
Rennes, France
Contact: Martine ESCOFFRE         
University Hosptial Toulouse Recruiting
Toulouse, France, 31000
Contact: Michel Attal, MD PhD         
CHU de Tours Not yet recruiting
Tours, France
Contact: Lotfi BENBOUBKER         
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
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Study Director: Michel ATTAL, MD University Hospital, Toulouse

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Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT03669445     History of Changes
Other Study ID Numbers: RC31/18/0212
First Posted: September 13, 2018    Key Record Dates
Last Update Posted: February 4, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Toulouse:
Newly Diagnosed Multiple myeloma
Daratumumab
Lenalidomide
Ixazomib
Dexamethasone
Additional relevant MeSH terms:
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Multiple Myeloma
Daratumumab
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone
Dexamethasone acetate
Lenalidomide
Ixazomib
BB 1101
Antibodies, Monoclonal
Glycine
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones