Phase 3
N=255
Aplidin - Dexamethasone in Relapsed/Refractory Myeloma
Relapsed/Refractory Multiple Myeloma
Bottom Line
View on ClinicalTrials.gov: NCT01102426 ↗Enrolled (actual)
255
Serious AEs
50.0%
Results posted
Oct 2020
Primary outcome: Primary: Progression Free Survival (PFS) as Per Intention-to-treat (ITT) — 2.6; 1.7 months — p==0.0054
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Plitidepsin (Drug); Dexamethasone (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- PharmaMar
- Primary completion
- Nov 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression Free Survival (PFS) as Per Intention-to-treat (ITT) |
2.6; 1.7 | =0.0054 sig |
| PRIMARY Percentage of Participants With Progression Free Survival (PFS) as Per Intention-to-treat (ITT) at 6 Months |
20.0; 10.0 | 0.0618 |
| SECONDARY Progression-free Survival (Investigator Assessment) |
2.9; 1.1 | < 0.0001 sig |
| SECONDARY Percentage of Participants With Progression-free Survival (Investigator Assessment) at 6 Months |
26.4; 8.1 | 0.0002 sig |
| SECONDARY Overall Survival |
11.6; 8.9 | =0.1261 |
| SECONDARY Percentage of Participants With Overall Survival at 12 Months |
48.3; 42.1 | 0.3625 |
| SECONDARY Percentage of Participants With Overall Survival at 24 Months |
30.8; 21.0 | 0.1037 |
| SECONDARY Duration of Response (Independent Review Committee) |
3.7; 1.8 | =0.1015 |
| SECONDARY Percentage of Participants With Duration of Response (Independent Review Committee) at 6 Months |
41.2; 0.0 | — |
| SECONDARY Duration of Response (Investigator Assessment) |
5.1; 0.9 | =0.0001 sig |
| SECONDARY Percentage of Participants With Duration of Response (Investigator Assessment) at 6 Months |
38.2; 0.0 | — |
| SECONDARY Best Overall Response (Independent Review Committee) |
2; 0; 15; 1; 22; 2 | — |
| SECONDARY Overall Response Rate (Independent Review Committee) |
22.8; 3.6 | <0.0001 sig |
| SECONDARY Overall Response Rate (Independent Review Committee) Excluding MR |
9.9; 1.2 | 0.0085 sig |
| SECONDARY Best Overall Response (Investigator Assessment) |
4; 0; 16; 1; 31; 0 | — |
| SECONDARY Overall Response Rate (Investigator Assessment) |
29.8; 1.2 | <0.0001 sig |
| SECONDARY Overall Response Rate (Investigator Assessment) Excluding MR |
11.7; 1.2 | 0.0029 sig |
Summary
Study of Plitidepsin in combination with dexamethasone versus dexamethasone alone in patients with relapsed/refractory multiple myeloma.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01102426). 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.