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NCT01568294

Japanese Phase 1 Study to Evaluate Tolerated Dose, Safety, and Efficacy of Pomalidomide in Patients With Refractory or Relapsed and Refractory Multiple Myeloma

Completed Phase 1 Last updated 12 November 2019
What this trial tests

Phase 1 trial testing pomalidomide in Multiple Myeloma in 12 participants. Completed in 8 July 2015.

Timeline
1 April 2012
Primary endpoint
8 July 2015
8 July 2015

Quick facts

Lead sponsorCelgene
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment12
Start date1 April 2012
Primary completion8 July 2015
Estimated completion8 July 2015
Sites8 locations across Japan

Drugs / interventions tested

Conditions studied

Sponsor

Celgene — full company profile →

Who can join

20 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 determine the tolerated dose of pomalidomide and also to evaluate the pharmacokinetics, safety and efficacy of pomalidomide in patients with refractory or relapsed and refractory multiple myeloma.

Publications & conference data

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

  1. Pomalidomide: the new immunomodulatory agent for the treatment of multiple myeloma.
    Chanan-Khan AA, Swaika A, Paulus A, Kumar SK, et al · · 2013 · cited 94× · PMID 24013664 · DOI 10.1038/bcj.2013.38
  2. Pomalidomide alone or in combination with dexamethasone in Japanese patients with refractory or relapsed and refractory multiple myeloma.
    Matsue K, Iwasaki H, Chou T, Tobinai K, et al · · 2015 · cited 11× · PMID 26292221 · DOI 10.1111/cas.12772

Verify or expand the search:

Other trials of pomalidomide

Trials testing the same drug.

Other recruiting trials for Multiple Myeloma

Currently open trials in the same condition.

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/NCT01568294.

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