Aplidin - Dexamethasone in Relapsed/Refractory Myeloma (ADMYRE)

This study is currently recruiting participants.
Verified April 2014 by PharmaMar
Sponsor:
Information provided by (Responsible Party):
PharmaMar
ClinicalTrials.gov Identifier:
NCT01102426
First received: March 31, 2010
Last updated: April 15, 2014
Last verified: April 2014
  Purpose

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


Condition Intervention Phase
Relapsed/Refractory Multiple Myeloma
Drug: plitidepsin + dexamethasone
Drug: dexamethasone
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized, Multicenter, Open-label, Phase III Study of Plitidepsin in Combination With Dexamethasone vs. Dexamethasone Alone in Patients With Relapsed/Refractory Multiple Myeloma

Resource links provided by NLM:


Further study details as provided by PharmaMar:

Primary Outcome Measures:
  • Progression Free Survival (PFS) as per intention-to-treat (ITT) [ Time Frame: Estimated average: 5 months. From randomization to the first evidence of progressive disease or death due to any cause ] [ Designated as safety issue: No ]
    To compare the efficacy of plitidepsin in combination with dexamethasone vs. dexamethasone alone as measured by progression-free survival (PFS) in patients with relapsed/refractory multiple myeloma (MM).


Secondary Outcome Measures:
  • Response rate [ Time Frame: Every 4 weeks untill progression ] [ Designated as safety issue: No ]
  • Duration of Response [ Time Frame: Estimated average: 3 months. From the date of first documentation of response to the date of disease progression or death. ] [ Designated as safety issue: No ]
  • Overall Survival [ Time Frame: Estimated average: 9 months. From randomization to the first evidence of progressive disease or death due to any cause ] [ Designated as safety issue: No ]
    Overal Survival (OS) is defined as the time from the date of randomization to the date of death or last contact


Estimated Enrollment: 250
Study Start Date: June 2010
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm A
plitidepsin + dexamethasone combination
Drug: plitidepsin + dexamethasone
plitidepsin: powder and solvent for concentrate for solution for infusion. 2 mg vial + 4 ml ampoule. 5 mg/m2 intravenously (i.v.) over three hours on Day 1 and 15 every 4 weeks. dexamethasone: 4 mg tablet. 40 mg orally on Day 1, 8, 15 and 22 every four weeks at least one hour before plitidepsin infusion.
Other Name: APLIDIN (plitidepsin)
Active Comparator: Arm B
dexamethasone single agent
Drug: dexamethasone
4 mg tablet. 40 mg orally on Day 1, 8, 15 and 22 every four weeks.

Detailed 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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 at least three but not more than six prior therapeutic regimens for MM, including induction therapy and stem cell transplant in candidate patients, which will be considered as only one regimen.
  • Patients must have received previous bortezomib-containing and lenalidomide-containing regimens (or thalidomide where lenalidomide is not available)
  • Women must have a negative serum pregnancy test
  • Voluntarily signed and dated written informed consent

Exclusion Criteria:

  • Concomitant diseases/conditions
  • Women who are pregnant or breast feeding.
  • Concomitant medications that include corticosteroids, chemotherapy, or other therapy that is or may be active against MM
  • Known hypersensitivity to any involved study drug or any of its formulation components
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01102426

Contacts
Contact: José Rodríguez Diaz-Pavón, M.D. +34 91-846-6157 ext -- jrodriguez@pharmamar.com

  Hide Study Locations
Locations
United States, Alabama
Recruiting
Tuscaloosa, Alabama, United States
United States, California
Recruiting
Los Angeles, California, United States
United States, Florida
Recruiting
Jacksonville, Florida, United States
United States, New York
Terminated
New York, New York, United States
United States, Ohio
Recruiting
Canton, Ohio, United States
United States, Texas
Recruiting
Houston, Texas, United States
United States, West Virginia
Withdrawn
Huntington, West Virginia, United States
Australia
Recruiting
Adelaide, Australia
Recruiting
Canberra, Australia
Withdrawn
Darlinghurst, Australia
Recruiting
Geelong, Australia
Recruiting
Parkville, Australia
Recruiting
Perth, Australia
Recruiting
South Brisbane, Australia
Recruiting
Woodvillle, Australia
Austria
Recruiting
Graz, Austria
Recruiting
Innsbruck, Austria
Withdrawn
Linz, Austria
Recruiting
Salzburg, Austria
Recruiting
St Pölten, Austria
Recruiting
St. Pölten, Austria
Recruiting
Wien, Austria
Belgium
Recruiting
Brugge, Belgium
Recruiting
Brussels, Belgium
Recruiting
Bruxelles, Belgium
Recruiting
Gent, Belgium
Czech Republic
Recruiting
Hradec Kralove, Czech Republic
Recruiting
Ostrava-Poruba, Czech Republic
Recruiting
Praha, Czech Republic
France
Withdrawn
Chalon Sur Saone Cedex, France
Recruiting
Lille, France
Recruiting
Nantes, France
Withdrawn
Pierre-Benite, France
Recruiting
Rouen, France
Recruiting
Vandoeuvre, France
Germany
Recruiting
Düsseldorf, Germany
Terminated
Essen, Germany
Recruiting
Frankfurt, Germany
Recruiting
Freiburg, Germany
Contact: Monika Engelhardt         
Terminated
Heidelberg, Germany
Withdrawn
Leverkusen, Germany
Recruiting
Munchen, Germany
Recruiting
Würzburg, Germany
Greece
Recruiting
Athens, Greece
Recruiting
Patras, Greece
Recruiting
Thessaloniki, Greece
Ireland
Recruiting
Dublin, Ireland
Italy
Recruiting
Genova, Italy
Terminated
Molinette di Torino (Torino), Italy
Recruiting
Reggio Emilia, Italy
Recruiting
Rozzano, Italy
Recruiting
San Giovanni Rotondo, Italy
Principal Investigator: Nicola Cascavilla, MD         
Recruiting
San Giovanni Rotondo, Italy
Korea, Republic of
Recruiting
Anyang, Korea, Republic of
Recruiting
Daejeon, Korea, Republic of
Recruiting
Hwasun, Korea, Republic of
Recruiting
Incheon, Korea, Republic of
Recruiting
Jeonju, Korea, Republic of
Recruiting
Seongnam, Korea, Republic of
1503 Recruiting
Seoul, Korea, Republic of
1504 Recruiting
Seoul, Korea, Republic of
1509 Recruiting
Seoul, Korea, Republic of
Netherlands
Recruiting
Rotterdam, Netherlands
New Zealand
Recruiting
Christchurch, New Zealand
Recruiting
Takapuna, Auckland, New Zealand
Poland
Recruiting
Opole, Poland
Recruiting
Warszawa, Poland
Portugal
Recruiting
Braga, Portugal
Withdrawn
Coimbra, Portugal
Recruiting
Porto, Portugal
Puerto Rico
Recruiting
Hato Rey, Puerto Rico
Spain
1 Recruiting
Barcelona, Spain
2 Recruiting
Barcelona, Spain
Terminated
Barcelona, Spain
2 Recruiting
Madrid, Spain
1 Recruiting
Madrid, Spain
Recruiting
Murcia, Spain
Terminated
Palma de Mallorca, Spain
Recruiting
Salamanca, Spain
Recruiting
San Sebastián, Spain
Recruiting
Valencia, Spain
Taiwan
Recruiting
Putz city, Taiwan
1 Recruiting
Taipei, Taiwan
2 Recruiting
Taipei, Taiwan
United Kingdom
Recruiting
Bournemouth, United Kingdom
Recruiting
Bradford, United Kingdom
1 Recruiting
London, United Kingdom
2 Recruiting
London, United Kingdom
Recruiting
Nottingham, United Kingdom
Sponsors and Collaborators
PharmaMar
Investigators
Principal Investigator: Óscar F. Ballester, M.D. Edwards Comprehensive Cancer Center, Marshall University (Huntington)
Principal Investigator: Rubén Niesvizky, M.D. NY Presbyterian Hosp. - Cornell University - NY
  More Information

No publications provided

Responsible Party: PharmaMar
ClinicalTrials.gov Identifier: NCT01102426     History of Changes
Other Study ID Numbers: APL-C-001-09
Study First Received: March 31, 2010
Last Updated: April 15, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by PharmaMar:
Multiple Myeloma
Aplidin
plitidepsin
dexamethasone

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on April 17, 2014