Trials / Completed
CompletedNCT02100657
Study of Plitidepsin (Aplidin®) in Combination With Bortezomib and Dexamethasone in Patients With Multiple Myeloma
Phase I Study of Plitidepsin (Aplidin®) in Combination With Bortezomib and Dexamethasone in Patients With Relapsed and/or Refractory Multiple Myeloma
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 39 (actual)
- Sponsor
- PharmaMar · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Plitidepsin | |
| DRUG | Bortezomib | |
| DRUG | Dexamethasone |
Timeline
- Start date
- 2014-06-01
- Primary completion
- 2018-06-01
- Completion
- 2018-06-01
- First posted
- 2014-04-01
- Last updated
- 2020-10-12
- Results posted
- 2020-10-12
Locations
7 sites across 2 countries: France, Spain
Source: ClinicalTrials.gov record NCT02100657. Inclusion in this directory is not an endorsement.