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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02100657
• Date of registration: 21/03/2014
• Prospective Registration: Yes
• Primary sponsor: PharmaMar
• Public title: Study of Plitidepsin (Aplidin®) in Combination With Bortezomib and Dexamethasone in Patients With Multiple Myeloma
• Scientific title: Phase I Study of Plitidepsin (Aplidin®) in Combination With Bortezomib and Dexamethasone in Patients With Relapsed and/or Refractory Multiple Myeloma
• Date of first enrolment: June 2014
• Target sample size: 39
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02100657
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Other. Masking: None (Open Label).
• Phase: Phase 1

Countries of recruitment

France, Spain

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Multiple Myeloma

Intervention(s)

Drug: Dexamethasone

Drug: Plitidepsin

Drug: Bortezomib

Primary Outcome(s)

Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs) [Time Frame: After 28-day cycle]

Recommended Dose of Bortezomib in Combination With Plitidepsin and Dexamethasone [Time Frame: After 28-day cycle]

Recommended Dose of Dexamethasone in Combination With Plitidepsin and Bortezomib [Time Frame: After 28-day cycle]

Recommended Dose of Plitidepsin in Combination With Bortezomib and Dexamethasone [Time Frame: After 28-day cycle]

Secondary Outcome(s)

Duration of Response [Time Frame: From the date of the first documentation of response to the date of PD or further therapy or death, up to 4 years]

Time to Progression Rates [Time Frame: From the date of the first infusion to the date of documented PD or death due to PD, up to 4 years]

Progression-free Survival [Time Frame: from the date of the first infusion to the date of documented PD or death, up to 4 years]

Overall Response Rate [Time Frame: Response or disease progression was assessed on Day 1 of each cycle, assessed up to 4 years]

Response According to International Myeloma Working Group Criteria [Time Frame: Response or disease progression was assessed on Day 1 of each cycle, assessed up to 4 years]

Time to Progression [Time Frame: From the date of the first infusion to the date of documented PD or death due to PD, up to 4 years]

Progression-free Survival Rates [Time Frame: From the date of the first infusion to the date of documented PD or death, up to 4 years]

Event-free Survival Rates [Time Frame: from the date of first infusion to the date of documented PD or death, up to 4 years]

Event-free Survival [Time Frame: From the date of first infusion to the date of documented PD or death, up to 4 years]

Secondary ID(s)

APL-A-012-13

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 12/10/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02100657