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NCT01936532: IFM2013-06

Phase II Trial Studying the Efficacy of a Triplet Combination of MLN9708, Lenalidomide and Dexamethasone as Induction Prior to, and as Consolidation After High-dose Therapy With Peripheral Stem Cell Transplantation Followed by MLN9708 Maintenance in the Initial Management of Multiple Myeloma in Patients Younger Than 66 Years

Completed Phase 2 Last updated 2 August 2023
What this trial tests

Phase 2 trial testing MLN9708 in Newly Diagnosed Multiple Myeloma in 42 participants. Completed in 4 June 2020.

Timeline
12 November 2014
Primary endpoint
1 March 2019
4 June 2020

Quick facts

Lead sponsorNantes University Hospital
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment42
Start date12 November 2014
Primary completion1 March 2019
Estimated completion4 June 2020
Sites10 locations across France

Drugs / interventions tested

Conditions studied

Sponsor

Nantes University Hospital

Who can join

Adults 18 to 66, any sex, with Newly Diagnosed Multiple Myeloma. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Sponsor's own description

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.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Spotlight on ixazomib: potential in the treatment of multiple myeloma.
    Muz B, Ghazarian RN, Ou M, Luderer MJ, et al · · 2016 · cited 87× · PMID 26811670 · DOI 10.2147/dddt.s93602
  2. An evidence-based review of ixazomib citrate and its potential in the treatment of newly diagnosed multiple myeloma.
    Offidani M, Corvatta L, Caraffa P, Gentili S, et al · · 2014 · cited 40× · PMID 25302026 · DOI 10.2147/ott.s49187
  3. The role of high-dose melphalan with autologous stem-cell transplant in multiple myeloma: is it time for a paradigm shift?
    Kazandjian D, Mo CC, Landgren O, Richardson PG. · · 2020 · cited 25× · PMID 32501533 · DOI 10.1111/bjh.16764
  4. Posttransplant maintenance therapy in multiple myeloma: the changing landscape.
    Sengsayadeth S, Malard F, Savani BN, Garderet L, et al · · 2017 · cited 25× · PMID 28338672 · DOI 10.1038/bcj.2017.23
  5. Trial Watch: Proteasomal inhibitors for anticancer therapy.
    Obrist F, Manic G, Kroemer G, Vitale I, et al · · 2015 · cited 17× · PMID 27308423 · DOI 10.4161/23723556.2014.974463

Verify or expand the search:

Other trials of MLN9708

Trials testing the same drug.

Other recruiting trials for Newly Diagnosed Multiple Myeloma

Currently open trials in the same condition.

Other Nantes University Hospital trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing