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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2018-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Multiple Myeloma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Plitidepsin

Intervention Type DRUG

Bortezomib

Intervention Type DRUG

Dexamethasone

Intervention Type DRUG

Interventions

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Plitidepsin

Intervention Type DRUG

Bortezomib

Intervention Type DRUG

Dexamethasone

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No