Aplidin - Dexamethasone in Relapsed/Refractory Myeloma (ADMYRE)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by PharmaMar
Sponsor:
Information provided by (Responsible Party):
PharmaMar
ClinicalTrials.gov Identifier:
NCT01102426
First received: March 31, 2010
Last updated: September 8, 2014
Last verified: August 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: December 2014
Estimated Primary Completion Date: December 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
1107 Recruiting
Tuscaloosa, Alabama, United States
United States, California
1103 Recruiting
Los Angeles, California, United States
United States, Florida
1105 Recruiting
Jacksonville, Florida, United States
United States, New York
1102 Terminated
New York, New York, United States
United States, Ohio
1104 Recruiting
Canton, Ohio, United States
United States, Texas
1106 Withdrawn
Houston, Texas, United States
United States, West Virginia
1101 Withdrawn
Huntington, West Virginia, United States
Australia
108 Recruiting
Adelaide, Australia
102 Recruiting
Canberra, Australia
107 Withdrawn
Darlinghurst, Australia
101 Recruiting
Geelong, Australia
105 Recruiting
Parkville, Australia
106 Recruiting
Perth, Australia
104 Recruiting
South Brisbane, Australia
109 Recruiting
Woodvillle, Australia
Austria
202 Recruiting
Graz, Austria
204 Recruiting
Innsbruck, Austria
206 Withdrawn
Linz, Austria
203 Recruiting
Salzburg, Austria
207 Withdrawn
St Pölten, Austria
201 Recruiting
Wien, Austria
208 Recruiting
Wien, Austria
205 Recruiting
Wien, Austria
Belgium
304 Recruiting
Brugge, Belgium
301 Recruiting
Brussels, Belgium
303 Recruiting
Brussels, Belgium
302 Recruiting
Gent, Belgium
Czech Republic
502 Recruiting
Brno, Czech Republic
503 Recruiting
Hradec Kralove, Czech Republic
501 Recruiting
Praha, Czech Republic
France
603 Withdrawn
Chalon Sur Saone Cedex, France
601 Recruiting
Lille, France
602 Recruiting
Nantes, France
605 Withdrawn
Pierre-Benite, France
606 Recruiting
Rouen, France
604 Recruiting
Vandoeuvre, France
Germany
709 Recruiting
Düsseldorf, Germany
705 Terminated
Essen, Germany
706 Recruiting
Frankfurt, Germany
707 Recruiting
Frankfurt, Germany
708 Recruiting
Freiburg, Germany
Contact: Monika Engelhardt         
703 Terminated
Heidelberg, Germany
701 Withdrawn
Leverkusen, Germany
702 Recruiting
Munchen, Germany
704 Recruiting
Würzburg, Germany
Greece
1301 Recruiting
Athens, Greece
1303 Recruiting
Patras, Greece
1302 Recruiting
Thessaloniki, Greece
Ireland
1401 Recruiting
Dublin, Ireland
Italy
806 Recruiting
Bari, Italy
801 Recruiting
Genova, Italy
805 Recruiting
Reggio Emilia, Italy
803 Active, not recruiting
Rozzano, Italy
804 Recruiting
San Giovanni Rotondo, Italy
Principal Investigator: Nicola Cascavilla, MD         
802 Terminated
Torino, Italy
Korea, Republic of
1502 Recruiting
Anyang, Korea, Republic of
1501 Recruiting
Daejeon, Korea, Republic of
1507 Recruiting
Hwasun, Korea, Republic of
1506 Recruiting
Incheon, Korea, Republic of
1505 Recruiting
Jeonju, Korea, Republic of
1508 Recruiting
Seongnam, Korea, Republic of
1503 Recruiting
Seoul, Korea, Republic of
1504 Recruiting
Seoul, Korea, Republic of
1509 Recruiting
Seoul, Korea, Republic of
Netherlands
901 Recruiting
Rotterdam, Netherlands
902 Recruiting
Rotterdam, Netherlands
New Zealand
1601 Recruiting
Christchurch, New Zealand
1602 Recruiting
Takapuna, Auckland, New Zealand
Poland
1704 Recruiting
Opole, Poland
1703 Recruiting
Warszawa, Poland
Portugal
1802 Recruiting
Braga, Portugal
1803 Withdrawn
Coimbra, Portugal
1801 Recruiting
Porto, Portugal
Puerto Rico
2001 Recruiting
Hato Rey, Puerto Rico
Spain
1201 Recruiting
Barcelona, Spain
1203 Recruiting
Barcelona, Spain
1209 Terminated
Barcelona, Spain
1210 Recruiting
Madrid, Spain
1207 Recruiting
Madrid, Spain
1206 Recruiting
Murcia, Spain
1204 Terminated
Palma de Mallorca, Spain
1208 Recruiting
Salamanca, Spain
1202 Recruiting
San Sebastián, Spain
1205 Recruiting
Valencia, Spain
Taiwan
1901 Recruiting
Putz city, Taiwan
1902 Recruiting
Taipei, Taiwan
1903 Recruiting
Taipei, Taiwan
United Kingdom
1003 Recruiting
Bournemouth, United Kingdom
1004 Recruiting
Bradford, United Kingdom
1001 Recruiting
London, United Kingdom
1002 Recruiting
London, United Kingdom
1005 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: September 8, 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 September 16, 2014