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

Pharma Mar

Status and phase: Completed; Phase 1

Conditions: Multiple Myeloma

Treatments: Drug: Bortezomib; Drug: Dexamethasone; Drug: Plitidepsin

Study type: Interventional

Funder types: Industry

Identifiers

NCT02100657

APL-A-012-13

Details and patient eligibility

About

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.

Full 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.

Enrollment: 39 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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39 participants in 1 patient group

plitidepsin + bortezomib + dexamethasone

Experimental group

Description:

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

Treatment:

Drug: Plitidepsin

Drug: Bortezomib

Drug: Dexamethasone