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NCT02112175: ARUMM

Lenalidomide vs Placebo Maintenance Therapy Following Melphalan Prednisone Velcade® Induction Therapy in NDMM

Completed Phase 3 Last updated 14 April 2021
What this trial tests

Phase 3 trial testing Lenalidomide in Multiple Myeloma in 46 participants. Completed in 12 October 2020.

Timeline
30 April 2014
Primary endpoint
12 October 2020
12 October 2020

Quick facts

Lead sponsorCelgene
PhasePhase 3
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment46
Start date30 April 2014
Primary completion12 October 2020
Estimated completion12 October 2020
Sites73 locations across France, Italy, Greece, Belgium, Spain

Drugs / interventions tested

Conditions studied

Sponsor

Celgene — full company profile →

Who can join

18 and older, any sex, with Multiple Myeloma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of this study is to compare the safety and efficacy of Lenalidomide versus Placebo maintenance following melphalan, prednisone and velcade induction therapy in newly diagnosed multiple myeloma. After the study is unblinded, subjects in treatment Arm A (Len 10 mg) will remain on study therapy at the Investigator's discretion and subjects in treatment Arm B (placebo), will be discontinued from study treatment. Subjects who discontinued from study treatment for any reason will enter the LTFU Phase.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Myeloma: management of the newly diagnosed high-risk patient.
    Dispenzieri A. · · 2016 · cited 16× · PMID 27913520 · DOI 10.1182/asheducation-2016.1.485

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Other trials of Lenalidomide

Trials testing the same drug.

Other recruiting trials for Multiple Myeloma

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Other Celgene trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02112175.

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