or
forgot password

Randomized, Multicenter, Open-label, Phase III Study of Plitidepsin in Combination With Dexamethasone vs. Dexamethasone Alone in Patients With Relapsed/Refractory Multiple Myeloma


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Relapsed/Refractory Multiple Myeloma

Thank you

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