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Safety and Efficacy Study of a Triplet Combination of MLN9708, Lenalidomide and Dexamethasone in the Initial Management of Multiple Myeloma (IFM2013-06)

NCT01936532 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2023-08-03

No results posted yet for this study

Summary

This is a phase II, multicenter, open-label study to evaluate the safety and efficacy of MLN9708 in combination with Lenalidomide and Dexamethasone in patients with newly diagnosed multiple myeloma. The patient population will consist of adult men and women younger than 66 years, who have a confirmed diagnosis of MM who meet eligibility criteria.

Following the screening period, patients will be enrolled and treated then, they will receive induction therapy (3 cycles), a systematic Peripheral Blood Stem Cell harvest. After Peripheral Blood Stem Cell Transplantation, patient will enter in the consolidation phase (early and late one) 2 months after transplantation. Finally, patients follow a Maintenance therapy (start 1 month after the last cycle of consolidation) during 12 months.

Conditions

  • Newly Diagnosed Multiple Myeloma

Interventions

DRUG

MLN9708

Induction therapy Patients will receive 3 cycles of induction therapy with MLN9708 (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 of a 28-day cycle. Consolidation therapy * Early consolidation (consolidation part 1) will comprise 2 cycles of MRD identical to induction therapy. * Late consolidation (consolidation part 2) will consist in 6 additional cycles of MLN9708 (4 mg on Days 1, 8 and 15) plus lenalidomide (25 mg on Days 1 through 21) of a 28-day cycle. Maintenance therapy MLN9708 monotherapy (4 mg/day), will be given on days 1, 8 and 15 of a 28 day cycle, during 12 months.

DRUG

Lenalidomide

DRUG

Dexamethasone

Sponsors & Collaborators

  • Nantes University Hospital

    lead OTHER

Principal Investigators

  • Philippe MOREAU · Nantes University Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
66 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-11-12
Primary Completion
2019-03-31
Completion
2020-06-04

Countries

  • France

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01936532 on ClinicalTrials.gov