Randomized, Multicenter, Open-label, Phase III Study of Plitidepsin in Combination With Dexamethasone vs. Dexamethasone Alone in Patients With Relapsed/Refractory Multiple Myeloma
18 Years
N/A
Both
Relapsed/Refractory Multiple Myeloma
Trial Information
Randomized, Multicenter, Open-label, Phase III Study of Plitidepsin in Combination With Dexamethasone vs. Dexamethasone Alone in Patients With Relapsed/Refractory Multiple Myeloma
Phase III Study in Patients with Relapsed/Refractory Multiple Myeloma to compare the
efficacy of plitidepsin in combination with dexamethasone vs. dexamethasone alone measured
by progression-free survival (PFS) and to evaluate tumor response, duration of response (DR)
and overall survival (OS). The evaluation of efficacy after crossover from dexamethasone
alone to plitidepsin and dexamethasone combination, of safety profile on both arms patients
and of pharmacokinetics (PK) and pharmacokinetic /pharmacodynamic (PK/PD) relationship will
be performed.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Progression Free Survival (PFS) as per intention-to-treat (ITT)
Outcome Description:
To compare the efficacy of plitidepsin in combination with dexamethasone vs. dexamethasone alone as measured by progression-free survival (PFS) in patients with relapsed/refractory multiple myeloma (MM).
Outcome Time Frame:
Estimated average: 5 months. From randomization to the first evidence of progressive disease or death due to any cause
Safety Issue:
No
Principal Investigator
Óscar F. Ballester, M.D.
Investigator Role:
Principal Investigator
Investigator Affiliation:
Edwards Comprehensive Cancer Center, Marshall University (Huntington)
Authority:
United States: Food and Drug Administration
Study ID:
APL-C-001-09
NCT ID:
NCT01102426
Start Date:
June 2010
Completion Date:
June 2014
Related Keywords:
- Relapsed/Refractory Multiple Myeloma
- Multiple Myeloma
- Aplidin
- plitidepsin
- dexamethasone
- Multiple Myeloma
- Neoplasms, Plasma Cell
Name | Location |
|---|---|
| UCLA Medical School | Los Angeles, California 90095-1670 |
| Gabrail Cancer Center Research | Canton, Ohio 44718 |
| NY Presbyterian Hosp. - Cornell University - NY | New York, New York 10021 |
| San Antonio Military Medical Center (SAMMC) | Fort Sam Houston, Texas 78234 |
| Edwards Comprehensive Cancer Center, Marshall University | Huntington, West Virginia 25701 |
