Study Association of Lenalidomide, Ixazomib, Dexamethasone and Daratumumab in Newly Diagnosed Standard Risk Multiple Myeloma

NCT03669445 | Unknown Phase 2 DMC

• 1 other identifier: RC31/18/0212
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 12

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.

Conditions

Multiple Myeloma

Keywords

Newly Diagnosed Multiple myeloma; Daratumumab; Lenalidomide; Ixazomib; Dexamethasone

Outcome Measures

Primary Outcomes (1)

• minimal residual disease-negativity rate

  after completion of the consolidation therapy and before maintenance

  22 months

Secondary Outcomes (4)

• Adverse events

  up to 54 Months

• Response rates

  3 months, 5 months, 7 months, 13 months, 25 months

• Progression free survival

  54 months

• Overall survival

  54 months

Study Arms (1)

four drugs combination

EXPERIMENTAL

21-day cycles induction, then 28-day cycles consolidation and maintenance with Lenalidomide, Ixazomib, and Dexamethasone Plus Daratumumab

Drug: Ixazomib; Drug: Lenalidomide; Drug: Dexamethasone; Drug: Daratumumab

Interventions

Ixazomib DRUG

21-day cycles induction and 28-day cycles consolidation

four drugs combination

Lenalidomide DRUG

21-day cycles induction and 28-day cycles consolidation and 28-day cycles maintenance therapy

four drugs combination

Dexamethasone DRUG

21-day cycles induction and 28-day cycles consolidation

four drugs combination

Daratumumab DRUG

21-day cycles induction and 28-day cycles consolidation

four drugs combination

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (12)

CHU Bordeaux

Bordeaux, France

NOT YET RECRUITING

CHU de Caen

Caen, France

NOT YET RECRUITING

CHU de Dijon

Dijon, France

NOT YET RECRUITING

CHU de Grenoble

Grenoble, France

NOT YET RECRUITING

CHRU de Lille

Lille, France

NOT YET RECRUITING

Hospices Civils de Lyon

Lyon, France

NOT YET RECRUITING

Institut Paoli Calmettes

Marseille, France

NOT YET RECRUITING

CHRU de Nancy

Nancy, France

NOT YET RECRUITING

CHU de Nantes

Nantes, France

NOT YET RECRUITING

CHU de Rennes

Rennes, France

NOT YET RECRUITING

University Hosptial Toulouse

Toulouse, 31000, France

RECRUITING

CHU de Tours

Tours, France

NOT YET RECRUITING

MeSH Terms

Conditions

Multiple Myeloma

Interventions

ixazomib; Lenalidomide; Dexamethasone; daratumumab

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Michel ATTAL, MD

  University Hospital, Toulouse

  STUDY DIRECTOR

Central Study Contacts

Laura BOGDANOVITCH, CRA

CONTACT

05 61 77 84 37; laura.bogdanovitch@chu-toulouse.fr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2018
• First Posted: September 13, 2018
• Study Start: December 31, 2018
• Primary Completion: March 1, 2024
• Study Completion: December 1, 2024
• Last Updated: July 30, 2020

Record last verified: 2020-07

Locations

FR (12)