Aplidin - Dexamethasone in Relapsed/Refractory Myeloma

Completed · Phase 3

Conditions studied: Relapsed/Refractory Multiple Myeloma

In brief

Study of Plitidepsin in combination with dexamethasone versus dexamethasone alone in patients with relapsed/refractory multiple myeloma.

Key facts

Study ID

NCT01102426

Run by

PharmaMar

People needed

255

Starts

2010-06-01

Expected to finish

2017-11-01

Last updated by the study team

2020-11-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 1103 — Los Angeles, California, United States
• 1105 — Jacksonville, Florida, United States
• 1102 — New York, New York, United States
• 1104 — Canton, Ohio, United States
• 108 — Adelaide, Australia
• 102 — Canberra, Australia
• 101 — Geelong, Australia
• 105 — Parkville, Australia
• 106 — Perth, Australia
• 104 — South Brisbane, Australia
• 109 — Woodville, Australia
• 202 — Graz, Austria
• 204 — Innsbruck, Austria
• 203 — Salzburg, Austria
• 201 — Vienna, Austria
• 205 — Vienna, Austria
• 208 — Vienna, Austria
• 304 — Bruges, Belgium
• 301 — Brussels, Belgium
• 303 — Brussels, Belgium
• 302 — Ghent, Belgium
• 502 — Brno, Czechia
• 503 — Hradec Králové, Czechia
• 501 — Prague, Czechia
• 1107 — Tuscaloosa, Alabama, United States

Full record on ClinicalTrials.gov

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