Clinical trial NCT02100657: Study of Plitidepsin (Aplidin®) in Combination With Bortezomib and Dexamethasone in Patients With Multiple Myeloma
Official title: Phase I Study of Plitidepsin (Aplidin®) in Combination With Bortezomib and Dexamethasone in Patients With Relapsed and/or Refractory Multiple Myeloma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Multiple Myeloma
Keywords: multiple myeloma
plitidepsin
APLIDIN
Lead sponsor: PharmaMar
Sponsor class: INDUSTRY
First posted: 2014-04-01
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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.

Eligibility 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

Primary outcomes:
measure: Recommended Dose of Plitidepsin in Combination With Bortezomib and Dexamethasone
timeFrame: After 28-day cycle
measure: Recommended Dose of Bortezomib in Combination With Plitidepsin and Dexamethasone
timeFrame: After 28-day cycle
measure: Recommended Dose of Dexamethasone in Combination With Plitidepsin and Bortezomib
timeFrame: After 28-day cycle
measure: Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs)
timeFrame: After 28-day cycle
Secondary outcomes:
measure: Response According to International Myeloma Working Group Criteria
timeFrame: Response or disease progression was assessed on Day 1 of each cycle, assessed up to 4 years
measure: Overall Response Rate
timeFrame: Response or disease progression was assessed on Day 1 of each cycle, assessed up to 4 years
measure: Duration of Response
timeFrame: From the date of the first documentation of response to the date of PD or further therapy or death, up to 4 years
measure: Time to Progression
timeFrame: From the date of the first infusion to the date of documented PD or death due to PD, up to 4 years
measure: Time to Progression Rates
timeFrame: From the date of the first infusion to the date of documented PD or death due to PD, up to 4 years
measure: Progression-free Survival
timeFrame: from the date of the first infusion to the date of documented PD or death, up to 4 years
measure: Progression-free Survival Rates
timeFrame: From the date of the first infusion to the date of documented PD or death, up to 4 years
measure: Event-free Survival
timeFrame: From the date of first infusion to the date of documented PD or death, up to 4 years
measure: Event-free Survival Rates
timeFrame: from the date of first infusion to the date of documented PD or death, up to 4 years
Other outcomes:
Locations:
city: Villejuif
country: France
facility: Institut Gustave Roussy
city: Badalona
country: Spain
facility: Hospital Universitario Germans Trias I Pujol
state: Barcelona
city: Pamplona
country: Spain
facility: Clínica Universidad de Navarra
state: Navarra
city: Madrid
country: Spain
facility: MD Anderson Cancer Center Madrid
city: Salamanca
country: Spain
facility: Hospital Universitario Salamanca
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocío
city: Valencia
country: Spain
facility: Hospital Universitari i Politècnic la Fe
Study officials:
References: