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Trial record 4 of 9 for:    aplidine

Study of Plitidepsin (Aplidin®) in Combination With Bortezomib and Dexamethasone in Patients With Multiple Myeloma

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2015 by PharmaMar
Sponsor:
Information provided by (Responsible Party):
PharmaMar
ClinicalTrials.gov Identifier:
NCT02100657
First received: March 21, 2014
Last updated: July 23, 2015
Last verified: July 2015
  Purpose
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.

Condition Intervention Phase
Multiple Myeloma
Drug: Plitidepsin
Drug: Bortezomib
Drug: Dexamethasone
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Phase I Study of Plitidepsin (Aplidin®) in Combination With Bortezomib and Dexamethasone in Patients With Relapsed and/or Refractory Multiple Myeloma

Resource links provided by NLM:


Further study details as provided by PharmaMar:

Primary Outcome Measures:
  • Recommended dose of plitidepsin in combinatio with bortezomib and dexamethasone [ Time Frame: After 28-day cycle ] [ Designated as safety issue: Yes ]

    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 define the RD, patients will be evaluated for DLTs during the first 28-day cycle. The RD will be the highest DL at which fewer than two out of six (33%) of evaluable patients experience a DLT during the first 28-day cycle.



Estimated Enrollment: 25
Study Start Date: June 2014
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: plitidepsin + bortezomib + dexamethasone

Plitidepsin will be administered as a 3-hour (h) intravenous (i.v.) infusion on Day (D) 1 and 15, every four weeks (q4wk).

Bortezomib will be administered as a subcutaneous (s.c.) injection on D1, 4, 8 and 11, q4wk, for a maximum of eight cycles.

Dexamethasone will be taken orally on D1, 8, 15 and 22, q4wk, for a maximum of eight cycles.

Drug: Plitidepsin Drug: Bortezomib Drug: Dexamethasone

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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  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: NCT02100657

Locations
France
Institut Gustave Roussy Recruiting
Paris, France
Contact: Dr. Vincent Ribrag         
Spain
Hospital Universitario Germans Trias I Pujol Recruiting
Badalona, Spain
Contact: Albert Oriol         
M.D. Anderson Recruiting
Madrid, Spain
Contact: Rebeca Iglesias         
Clínica Universitaria de Navarra Recruiting
Pamplona, Spain
Contact: Felipe Prosper         
Hospital Universitario Salamanca Recruiting
Salamanca, Spain
Contact: María V. Mateos         
Hospital Universitario Virgen del Rocío Recruiting
Sevilla, Spain
Contact: José Pérez         
Hospital Universitario La Fé Recruiting
Valencia, Spain
Contact: Javier De la Rubia         
Sponsors and Collaborators
PharmaMar
  More Information

Responsible Party: PharmaMar
ClinicalTrials.gov Identifier: NCT02100657     History of Changes
Other Study ID Numbers: APL-A-012-13 
Study First Received: March 21, 2014
Last Updated: July 23, 2015
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by PharmaMar:
multiple myeloma
plitidepsin
APLIDIN

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
Bortezomib
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents

ClinicalTrials.gov processed this record on December 02, 2016