Phase 1
Completed N=8
Study of Plitidepsin (Aplidin®) in Combination With Bortezomib and Dexamethasone in Patients With Multiple Myeloma
Source: ClinicalTrials.gov NCT02100657 ↗Enrolled (actual)
8
Serious AEs
55.6%
Results posted
Oct 2020
Primary outcomePrimary: Recommended Dose of Plitidepsin in Combination With Bortezomib and Dexamethasone — 5.0 mg/m^2 of plitidepsin
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Recommended Dose of Plitidepsin in Combination With Bortezomib and Dexamethasone |
5.0 | — |
| PRIMARY Recommended Dose of Bortezomib in Combination With Plitidepsin and Dexamethasone |
1.3 | — |
| PRIMARY Recommended Dose of Dexamethasone in Combination With Plitidepsin and Bortezomib |
40.0 | — |
| PRIMARY Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs) |
0; 0; 2 | — |
| SECONDARY Response According to International Myeloma Working Group Criteria |
0; 1; 1; 1; 0; 0 | — |
| SECONDARY Overall Response Rate |
57.1; 66.7; 22.2 | — |
| SECONDARY Duration of Response |
21.0; 12.6; 12.3 | — |
| SECONDARY Time to Progression |
10.4; 13.6; 2.8 | — |
| SECONDARY Time to Progression Rates |
85.7; 100.0; 44.4; 71.4; 66.7; 26.7 | — |
| SECONDARY Progression-free Survival |
10.4; 13.6; 2.8 | — |
| SECONDARY Progression-free Survival Rates |
85.7; 100.0; 44.4; 71.4; 66.7; 26.7 | — |
| SECONDARY Event-free Survival |
10.4; 13.6; 2.8 | — |
| SECONDARY Event-free Survival Rates |
85.7; 100.0; 44.4; 71.4; 66.7; 26.7 | — |
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
Data sourced from ClinicalTrials.gov (NCT02100657). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.