Aplidin - Dexamethasone in Relapsed/Refractory Myeloma

NCT01102426 | Completed Phase 3 Results DMC

• 1 other identifier: APL-C-001-09
• Study Type: interventional
• Target: 255
• Locations: 18 countries
• Sites: 76

Brief Summary

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

Conditions

Relapsed/Refractory Multiple Myeloma

Keywords

Multiple Myeloma; Aplidin; plitidepsin; dexamethasone

Outcome Measures

Primary Outcomes (2)

• Progression Free Survival (PFS) as Per Intention-to-treat (ITT)

  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). Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions

  From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years

• Percentage of Participants With Progression Free Survival (PFS) as Per Intention-to-treat (ITT) at 6 Months

  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). Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions

  From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months

Secondary Outcomes (15)

• Progression-free Survival (Investigator Assessment)

  From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years

• Percentage of Participants With Progression-free Survival (Investigator Assessment) at 6 Months

  From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months

• Overall Survival

  From randomization to the death due to any cause,assessed up to 5 years

• Percentage of Participants With Overall Survival at 12 Months

  From randomization to the death due to any cause,assessed up to 12 months

• Percentage of Participants With Overall Survival at 24 Months

  From randomization to the death due to any cause,assessed up to 24 months

Study Arms (2)

Plitidepsin+Dexamethasone

EXPERIMENTAL

plitidepsin + dexamethasone combination

Drug: Plitidepsin; Drug: Dexamethasone

Dexamethasone

ACTIVE COMPARATOR

dexamethasone single agent

Drug: Dexamethasone

Interventions

Plitidepsin DRUG

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.

Also known as: APLIDIN (plitidepsin)

Plitidepsin+Dexamethasone

Dexamethasone DRUG

4 mg tablet. 40 mg orally on Day 1, 8, 15 and 22 every four weeks.

Also known as: DXN

Dexamethasone; Plitidepsin+Dexamethasone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• PharmaMar: lead

Study Sites (82)

1107

Tuscaloosa, Alabama, United States

Location

1103

Los Angeles, California, United States

Location

1105

Jacksonville, Florida, United States

Location

1102

New York, New York, United States

Location

1104

Canton, Ohio, United States

Location

108

Adelaide, Australia

Location

102

Canberra, Australia

Location

101

Geelong, Australia

Location

105

Parkville, Australia

Location

106

Perth, Australia

Location

104

South Brisbane, Australia

Location

109

Woodville, Australia

Location

202

Graz, Austria

Location

204

Innsbruck, Austria

Location

203

Salzburg, Austria

Location

201

Vienna, Austria

Location

205

Vienna, Austria

Location

208

Vienna, Austria

Location

304

Bruges, Belgium

Location

301

Brussels, Belgium

Location

303

Brussels, Belgium

Location

302

Ghent, Belgium

Location

502

Brno, Czechia

Location

503

Hradec Králové, Czechia

Location

501

Prague, Czechia

Location

601

Lille, France

Location

602

Nantes, France

Location

606

Rouen, France

Location

604

Vandœuvre-lès-Nancy, France

Location

709

Düsseldorf, Germany

Location

705

Essen, Germany

Location

706

Frankfurt, Germany

Location

707

Frankfurt, Germany

Location

708

Freiburg im Breisgau, Germany

Location

703

Heidelberg, Germany

Location

702

München, Germany

Location

704

Würzburg, Germany

Location

1301

Athens, Greece

Location

1303

Pátrai, Greece

Location

1302

Thessaloniki, Greece

Location

1401

Dublin, Ireland

Location

806

Bari, Italy

Location

801

Genova, Italy

Location

805

Reggio Emilia, Italy

Location

803

Rozzano, Italy

Location

804

San Giovanni Rotondo, Italy

Location

802

Torino, Italy

Location

901

Rotterdam, Netherlands

Location

902

Rotterdam, Netherlands

Location

1601

Christchurch, New Zealand

Location

1602

Takapuna, New Zealand

Location

1704

Opole, Poland

Location

1703

Warsaw, Poland

Location

1802

Braga, Portugal

Location

1801

Porto, Portugal

Location

2001

San Juan, Puerto Rico

Location

1502

Anyang, South Korea

Location

1501

Daejeon, South Korea

Location

1507

Hwasun, South Korea

Location

1506

Incheon, South Korea

Location

1505

Jeonju, South Korea

Location

1508

Seongnam, South Korea

Location

1503

Seoul, South Korea

Location

1504

Seoul, South Korea

Location

1509

Seoul, South Korea

Location

1201

Barcelona, Spain

Location

1203

Barcelona, Spain

Location

1209

Barcelona, Spain

Location

1207

Madrid, Spain

Location

1210

Madrid, Spain

Location

1206

Murcia, Spain

Location

1204

Palma de Mallorca, Spain

Location

1208

Salamanca, Spain

Location

1202

San Sebastián, Spain

Location

1205

Valencia, Spain

Location

1901

Taipei, Taiwan

Location

1902

Taipei, Taiwan

Location

1903

Taipei, Taiwan

Location

1003

Bournemouth, United Kingdom

Location

1004

Bradford, United Kingdom

Location

1001

London, United Kingdom

Location

1005

Nottingham, United Kingdom

Location

MeSH Terms

Conditions

Multiple Myeloma

Interventions

plitidepsin; Dexamethasone

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Results Point of Contact

• Title: Pharma Mar, S.A.
• Organization: Pharma Mar, S.A.

clinicaltrials@pharmamar.com

0034918466000

Study Officials

• Óscar F. Ballester, M.D.

  Edwards Comprehensive Cancer Center, Marshall University (Huntington)

  PRINCIPAL INVESTIGATOR

• Rubén Niesvizky, M.D.

  NY Presbyterian Hosp. - Cornell University - NY

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2010
• First Posted: April 13, 2010
• Study Start: June 1, 2010
• Primary Completion: November 1, 2017
• Study Completion: November 1, 2017
• Last Updated: November 10, 2020
• Results First Posted: October 22, 2020

Record last verified: 2020-10

Locations

IE (1); TW (3); BE (4); AU (7); GB (4); PR (1); DE (8); PT (2); US (5); FR (4); IT (6); GR (3); NL (2); KR (9); CZ (3); PL (2); ES (10); NZ (2)