Clinical trial · Interventional
Aplidin - Dexamethasone in Relapsed/Refractory Myeloma
Randomized, Multicenter, Open-label, Phase III Study of Plitidepsin in Combination With Dexamethasone vs. Dexamethasone Alone in Patients With Relapsed/Refractory Multiple Myeloma
NCT01102426CI-TRIAL-00048207ADMYREcompletedPhase 3Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Study of Plitidepsin in combination with dexamethasone versus dexamethasone alone in patients with relapsed/refractory multiple myeloma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Relapsed/Refractory Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dexamethasone | Drug | Dexamethasone | ALIAS |
| Plitidepsin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Plitidepsin+Dexamethasone
- description
- plitidepsin + dexamethasone combination
- interventionNames
- Drug: Plitidepsin
- Drug: Dexamethasone
- type
- ACTIVE_COMPARATOR
- label
- Dexamethasone
- description
- dexamethasone single agent
- interventionNames
- Drug: Dexamethasone
Primary outcomes (2)
- measure
- Progression Free Survival (PFS) as Per Intention-to-treat (ITT)
- timeFrame
- From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥ 18 years. * Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≤ 2 * Life expectancy ≥ 3 months. * Patients previously diagnosed with multiple myeloma * Patients must have relapsed or relapsed and refractory multiple myeloma (MM) after at least three but not more than six prior therapeutic regimens for MM, including induction therapy and stem cell transplant in candidate patients, which will be considered as only one regimen. * Patients must have received previous bortezomib-containing and lenalidomide-containing regimens (or thalidomide where lenalidomide is not available) * Women must have a negative serum pregnancy test * Voluntarily signed and dated written informed consent Exclusion Criteria: * Concomitant diseases/conditions * Women who are pregnant or breast feeding. * Concomitant medications that include corticosteroids, chemotherapy, or other therapy that is or may be active against MM * Known hypersensitivity to any involved study drug or any of its formulation components
References
Publications (0)
Data not yet available
No reference posted for this study.