Aplidin - Dexamethasone in Relapsed/Refractory Myeloma

Last updated: October 21, 2020
Sponsor: PharmaMar
Overall Status: Completed

Phase

3

Condition

Multiple Myeloma

Red Blood Cell Disorders

Leukemia

Treatment

N/A

Clinical Study ID

NCT01102426
APL-C-001-09
  • Ages > 18
  • All Genders

Study Summary

Study of Plitidepsin in combination with dexamethasone versus dexamethasone alone in patients with relapsed/refractory multiple myeloma.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age ≥ 18 years.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≤ 2
  • Life expectancy ≥ 3 months.
  • Patients previously diagnosed with multiple myeloma
  • Patients must have relapsed or relapsed and refractory multiple myeloma (MM) after atleast three but not more than six prior therapeutic regimens for MM, includinginduction therapy and stem cell transplant in candidate patients, which will beconsidered as only one regimen.
  • Patients must have received previous bortezomib-containing and lenalidomide-containingregimens (or thalidomide where lenalidomide is not available)
  • Women must have a negative serum pregnancy test
  • Voluntarily signed and dated written informed consent

Exclusion

Exclusion Criteria:

  • Concomitant diseases/conditions
  • Women who are pregnant or breast feeding.
  • Concomitant medications that include corticosteroids, chemotherapy, or other therapythat is or may be active against MM
  • Known hypersensitivity to any involved study drug or any of its formulation components

Study Design

Total Participants: 255
Study Start date:
June 01, 2010
Estimated Completion Date:
November 30, 2017

Study Description

Phase III Study in Patients with Relapsed/Refractory Multiple Myeloma to compare the efficacy of plitidepsin in combination with dexamethasone vs. dexamethasone alone measured by progression-free survival (PFS) and to evaluate tumor response, duration of response (DR), overall survival (OS) and to rule out any effect of plitidepsin on the duration of the QT/QTc interval (time corresponding to the beginning of depolarization to re-polarization of the ventricles).

Connect with a study center

  • 108

    Adelaide,
    Australia

    Site Not Available

  • Mater Adult Hospital

    Brisbane, 4101
    Australia

    Site Not Available

  • 102

    Canberra,
    Australia

    Site Not Available

  • 107

    Darlinghurst,
    Australia

    Site Not Available

  • 101

    Geelong,
    Australia

    Site Not Available

  • 105

    Parkville,
    Australia

    Site Not Available

  • 106

    Perth,
    Australia

    Site Not Available

  • 104

    South Brisbane,
    Australia

    Site Not Available

  • 109

    Woodville,
    Australia

    Site Not Available

  • 109

    Woodvillle,
    Australia

    Site Not Available

  • 202

    Graz,
    Austria

    Site Not Available

  • 204

    Innsbruck,
    Austria

    Site Not Available

  • 206

    Linz,
    Austria

    Site Not Available

  • 203

    Salzburg,
    Austria

    Site Not Available

  • 207

    St Pölten,
    Austria

    Site Not Available

  • empty

    St. Pölten,
    Austria

    Site Not Available

  • 201

    Wien,
    Austria

    Site Not Available

  • 205

    Wien,
    Austria

    Site Not Available

  • 208

    Wien,
    Austria

    Site Not Available

  • 304

    Brugge,
    Belgium

    Site Not Available

  • 301

    Brussels,
    Belgium

    Site Not Available

  • 303

    Brussels,
    Belgium

    Site Not Available

  • empty

    Bruxelles,
    Belgium

    Site Not Available

  • 302

    Gent,
    Belgium

    Site Not Available

  • empty

    Ostrava-Poruba,
    Czech Republic

    Site Not Available

  • 502

    Brno,
    Czechia

    Site Not Available

  • 503

    Hradec Kralove,
    Czechia

    Site Not Available

  • 501

    Praha,
    Czechia

    Site Not Available

  • 603

    Chalon Sur Saone Cedex,
    France

    Site Not Available

  • 601

    Lille,
    France

    Site Not Available

  • 602

    Nantes,
    France

    Site Not Available

  • 605

    Pierre-Benite,
    France

    Site Not Available

  • 606

    Rouen,
    France

    Site Not Available

  • 604

    Vandoeuvre,
    France

    Site Not Available

  • 604

    Vandœuvre-lès-Nancy,
    France

    Site Not Available

  • 709

    Düsseldorf,
    Germany

    Site Not Available

  • 705

    Essen,
    Germany

    Site Not Available

  • 706

    Frankfurt,
    Germany

    Site Not Available

  • 707

    Frankfurt,
    Germany

    Site Not Available

  • 708

    Freiburg,
    Germany

    Site Not Available

  • 703

    Heidelberg,
    Germany

    Site Not Available

  • 701

    Leverkusen,
    Germany

    Site Not Available

  • 702

    Munchen,
    Germany

    Site Not Available

  • Universitätsklinikum Würzburg - Med. Klinik und Poliklinik II

    Würzburg, 97080
    Germany

    Site Not Available

  • 704

    Würzburg,
    Germany

    Site Not Available

  • 1301

    Athens,
    Greece

    Site Not Available

  • 1303

    Patras,
    Greece

    Site Not Available

  • 1302

    Thessaloniki,
    Greece

    Site Not Available

  • 1401

    Dublin,
    Ireland

    Site Not Available

  • 806

    Bari,
    Italy

    Site Not Available

  • 801

    Genova,
    Italy

    Site Not Available

  • empty

    Molinette di Torino (Torino),
    Italy

    Site Not Available

  • 805

    Reggio Emilia,
    Italy

    Site Not Available

  • 803

    Rozzano,
    Italy

    Site Not Available

  • 804

    San Giovanni Rotondo,
    Italy

    Site Not Available

  • 802

    Torino,
    Italy

    Site Not Available

  • 1502

    Anyang,
    Korea, Republic of

    Site Not Available

  • empty

    Bundang,
    Korea, Republic of

    Site Not Available

  • 1501

    Daejeon,
    Korea, Republic of

    Site Not Available

  • 1507

    Hwasun,
    Korea, Republic of

    Site Not Available

  • 1506

    Incheon,
    Korea, Republic of

    Site Not Available

  • 1505

    Jeonju,
    Korea, Republic of

    Site Not Available

  • 1508

    Seongnam,
    Korea, Republic of

    Site Not Available

  • 1503

    Seoul,
    Korea, Republic of

    Site Not Available

  • 1504

    Seoul,
    Korea, Republic of

    Site Not Available

  • 1509

    Seoul,
    Korea, Republic of

    Site Not Available

  • 901

    Rotterdam,
    Netherlands

    Site Not Available

  • 902

    Rotterdam,
    Netherlands

    Site Not Available

  • 1601

    Christchurch,
    New Zealand

    Site Not Available

  • 1602

    Takapuna,
    New Zealand

    Site Not Available

  • 1602

    Takapuna, Auckland,
    New Zealand

    Site Not Available

  • 1704

    Opole,
    Poland

    Site Not Available

  • 1703

    Warszawa,
    Poland

    Site Not Available

  • 1802

    Braga,
    Portugal

    Site Not Available

  • 1803

    Coimbra,
    Portugal

    Site Not Available

  • 1801

    Porto,
    Portugal

    Site Not Available

  • 2001

    Hato Rey,
    Puerto Rico

    Site Not Available

  • 2001

    San Juan,
    Puerto Rico

    Site Not Available

  • 1201

    Barcelona,
    Spain

    Site Not Available

  • 1203

    Barcelona,
    Spain

    Site Not Available

  • 1209

    Barcelona,
    Spain

    Site Not Available

  • 1207

    Madrid,
    Spain

    Site Not Available

  • 1210

    Madrid,
    Spain

    Site Not Available

  • 1206

    Murcia,
    Spain

    Site Not Available

  • 1204

    Palma de Mallorca,
    Spain

    Site Not Available

  • 1208

    Salamanca,
    Spain

    Site Not Available

  • Hospital Donostia

    San Sebastián, 20014
    Spain

    Site Not Available

  • 1202

    San Sebastián,
    Spain

    Site Not Available

  • 1205

    Valencia,
    Spain

    Site Not Available

  • 1901

    Putz city,
    Taiwan

    Site Not Available

  • 1901

    Taipei,
    Taiwan

    Site Not Available

  • 1902

    Taipei,
    Taiwan

    Site Not Available

  • 1903

    Taipei,
    Taiwan

    Site Not Available

  • empty

    Taiwan,
    Taiwan

    Site Not Available

  • 1003

    Bournemouth,
    United Kingdom

    Site Not Available

  • 1004

    Bradford,
    United Kingdom

    Site Not Available

  • 1001

    London,
    United Kingdom

    Site Not Available

  • 1005

    Nottingham,
    United Kingdom

    Site Not Available

  • 1107

    Tuscaloosa, Alabama
    United States

    Site Not Available

  • 1103

    Los Angeles, California
    United States

    Site Not Available

  • 1105

    Jacksonville, Florida
    United States

    Site Not Available

  • 1102

    New York, New York
    United States

    Site Not Available

  • 1104

    Canton, Ohio
    United States

    Site Not Available

  • San Antonio Military Medical Center (SAMMC)

    Fort Sam Houston, Texas 78234
    United States

    Site Not Available

  • 1106

    Houston, Texas
    United States

    Site Not Available

  • 1101

    Huntington, West Virginia
    United States

    Site Not Available

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