Study of Plitidepsin (Aplidin®) in Combination With Bortezomib and Dexamethasone in Patients With Multiple Myeloma
Conditions
Multiple Myeloma
Conditions: official terms
Multiple Myeloma - Neoplasms, Plasma Cell
Conditions: Keywords
multiple myeloma, plitidepsin, APLIDIN
Study Type
Interventional
Study Phase
Phase 1
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label
Intervention
Name: Plitidepsin Type: Drug
Name: Bortezomib Type: Drug
Name: Dexamethasone Type: Drug
Overall Status
Recruiting
Summary
Study of Plitidepsin (Aplidin®) to determine the recommended dose (RD) of plitidepsin in Combination with Bortezomib and Dexamethasone in Patients with Relapsed and/or Refractory Multiple Myeloma.
Detailed Description
Phase I Multicenter, Open-label, Dose-escalating Clinical and Pharmacokinetic Trial of Plitidepsin (Aplidin®) to determine the recommended dose (RD) of plitidepsin in combination with bortezomib and dexamethasone in patients with relapsed and/or refractory multiple myeloma (MM), to determine the efficacy of the combination plitidepsin/bortezomib/dexamethasone, to evaluate the safety and tolerability of the combination in patients with relapsing and/or refractory MM and to study the pharmacokinetics (PK) and pharmacodynamics (PDy) of plitidepsin in combination with bortezomib and dexamethasone.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- Age ≥ 18 years.

- Prior autologous transplantation (HSCT) patients are allowed.

- Patients must have received at least one previous treatment line of induction, chemotherapy, chemotherapy and transplantation or previous treatment with bortezomib or another proteasome drug

Exclusion Criteria:

- Previous treatment with plitidepsin.

- Active or metastatic primary malignancy other than MM.

- Serious concomitant systemic disorders

- History of hypersensitivity reactions to bortezomib, polyoxyl 35 castor oil or mannitol

- Neuropathy

- Pregnant and/or lactating women

- HIV infection

- Active hepatitis B or C virus infection.

- Treatment with any Investigational Medicinal Product (IMP) in the 30 days before inclusion in the study

- Plasma cell leukemia at the time of study entry

- Contraindication for the use of steroids
Locations
Institut Gustave Roussy
Paris, France
Status: Recruiting
Contact: Dr. Vincent Ribrag - - - -
Hospital Universitario Germans Trias I Pujol
Badalona, Spain
Status: Recruiting
Contact: Albert Oriol - --
M.D. Anderson
Madrid, Spain
Status: Recruiting
Contact: Rebeca Iglesias - --
Clínica Universitaria de Navarra
Pamplona, Spain
Status: Recruiting
Contact: Felipe Prosper - --
Hospital Universitario Salamanca
Salamanca, Spain
Status: Recruiting
Contact: María V. Mateos - --
Hospital Universitario Virgen del Rocío
Sevilla, Spain
Status: Recruiting
Contact: José Pérez - --
Hospital Universitario La Fé
Valencia, Spain
Status: Recruiting
Contact: Javier De la Rubia - --
Start Date
June 2014
Completion Date
March 2016
Sponsors
PharmaMar
Source
PharmaMar
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page