Clinical trial NCT01102426: Aplidin - Dexamethasone in Relapsed/Refractory Myeloma
Official title: Randomized, Multicenter, Open-label, Phase III Study of Plitidepsin in Combination With Dexamethasone vs. Dexamethasone Alone in Patients With Relapsed/Refractory Multiple Myeloma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Relapsed/Refractory Multiple Myeloma
Keywords: Multiple Myeloma
Aplidin
plitidepsin
dexamethasone
Lead sponsor: PharmaMar
Sponsor class: INDUSTRY
First posted: 2010-04-13
Enrollment: 255
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed description: 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), overall survival (OS) and to rule out any effect of plitidepsin on the duration of the QT/QTc interval (time corresponding to the beginning of depolarization to re-polarization of the ventricles).

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

Primary outcomes:
measure: Progression Free Survival (PFS) as Per Intention-to-treat (ITT)
timeFrame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years
measure: Percentage of Participants With Progression Free Survival (PFS) as Per Intention-to-treat (ITT) at 6 Months
timeFrame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months
Secondary outcomes:
measure: Progression-free Survival (Investigator Assessment)
timeFrame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years
measure: Percentage of Participants With Progression-free Survival (Investigator Assessment) at 6 Months
timeFrame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months
measure: Overall Survival
timeFrame: From randomization to the death due to any cause,assessed up to 5 years
measure: Percentage of Participants With Overall Survival at 12 Months
timeFrame: From randomization to the death due to any cause,assessed up to 12 months
measure: Percentage of Participants With Overall Survival at 24 Months
timeFrame: From randomization to the death due to any cause,assessed up to 24 months
measure: Duration of Response (Independent Review Committee)
timeFrame: From the date of first documentation of response to the date of disease progression or death, assessed up to 5 years
measure: Percentage of Participants With Duration of Response (Independent Review Committee) at 6 Months
timeFrame: From the date of first documentation of response to the date of disease progression or death, assessed up to 6 months
measure: Duration of Response (Investigator Assessment)
timeFrame: From the date of first documentation of response to the date of disease progression or death, assessed up to 5 years
measure: Percentage of Participants With Duration of Response (Investigator Assessment) at 6 Months
timeFrame: From the date of first documentation of response to the date of disease progression or death, assessed up to 6 months
measure: Best Overall Response (Independent Review Committee)
timeFrame: From the date of first documentation of response to the date of disease progression or death, assessed up to 5 years
measure: Overall Response Rate (Independent Review Committee)
timeFrame: From the date of first documentation of response to the date of disease progression or death, assessed up to 5 years
measure: Overall Response Rate (Independent Review Committee) Excluding MR
timeFrame: From the date of first documentation of response to the date of disease progression or death, assessed up to 5 years
measure: Best Overall Response (Investigator Assessment)
timeFrame: From the date of first documentation of response to the date of disease progression or death, assessed up to 5 years
measure: Overall Response Rate (Investigator Assessment)
timeFrame: From the date of first documentation of response to the date of disease progression or death, assessed up to 5 years
measure: Overall Response Rate (Investigator Assessment) Excluding MR
timeFrame: From the date of first documentation of response to the date of disease progression or death, assessed up to 5 years
Other outcomes:
Locations:
city: Tuscaloosa
country: United States
facility: 1107
state: Alabama
city: Los Angeles
country: United States
facility: 1103
state: California
city: Jacksonville
country: United States
facility: 1105
state: Florida
city: New York
country: United States
facility: 1102
state: New York
city: Canton
country: United States
facility: 1104
state: Ohio
city: Adelaide
country: Australia
facility: 108
city: Canberra
country: Australia
facility: 102
city: Geelong
country: Australia
facility: 101
city: Parkville
country: Australia
facility: 105
city: Perth
country: Australia
facility: 106
city: South Brisbane
country: Australia
facility: 104
city: Woodville
country: Australia
facility: 109
city: Graz
country: Austria
facility: 202
city: Innsbruck
country: Austria
facility: 204
city: Salzburg
country: Austria
facility: 203
city: Wien
country: Austria
facility: 201
city: Wien
country: Austria
facility: 205
city: Wien
country: Austria
facility: 208
city: Brugge
country: Belgium
facility: 304
city: Brussels
country: Belgium
facility: 301
city: Brussels
country: Belgium
facility: 303
city: Gent
country: Belgium
facility: 302
city: Brno
country: Czechia
facility: 502
city: Hradec Kralove
country: Czechia
facility: 503
city: Praha
country: Czechia
facility: 501
city: Lille
country: France
facility: 601
city: Nantes
country: France
facility: 602
city: Rouen
country: France
facility: 606
city: Vandœuvre-lès-Nancy
country: France
facility: 604
city: Düsseldorf
country: Germany
facility: 709
city: Essen
country: Germany
facility: 705
city: Frankfurt
country: Germany
facility: 706
city: Frankfurt
country: Germany
facility: 707
city: Freiburg
country: Germany
facility: 708
city: Heidelberg
country: Germany
facility: 703
city: Munchen
country: Germany
facility: 702
city: Würzburg
country: Germany
facility: 704
city: Athens
country: Greece
facility: 1301
city: Patras
country: Greece
facility: 1303
city: Thessaloniki
country: Greece
facility: 1302
city: Dublin
country: Ireland
facility: 1401
city: Bari
country: Italy
facility: 806
city: Genova
country: Italy
facility: 801
city: Reggio Emilia
country: Italy
facility: 805
city: Rozzano
country: Italy
facility: 803
city: San Giovanni Rotondo
country: Italy
facility: 804
city: Torino
country: Italy
facility: 802
city: Anyang
country: Korea, Republic of
facility: 1502
city: Daejeon
country: Korea, Republic of
facility: 1501
city: Hwasun
country: Korea, Republic of
facility: 1507
city: Incheon
country: Korea, Republic of
facility: 1506
city: Jeonju
country: Korea, Republic of
facility: 1505
city: Seongnam
country: Korea, Republic of
facility: 1508
city: Seoul
country: Korea, Republic of
facility: 1503
city: Seoul
country: Korea, Republic of
facility: 1504
city: Seoul
country: Korea, Republic of
facility: 1509
city: Rotterdam
country: Netherlands
facility: 901
city: Rotterdam
country: Netherlands
facility: 902
city: Christchurch
country: New Zealand
facility: 1601
city: Takapuna
country: New Zealand
facility: 1602
city: Opole
country: Poland
facility: 1704
city: Warszawa
country: Poland
facility: 1703
city: Braga
country: Portugal
facility: 1802
city: Porto
country: Portugal
facility: 1801
city: San Juan
country: Puerto Rico
facility: 2001
city: Barcelona
country: Spain
facility: 1201
city: Barcelona
country: Spain
facility: 1203
city: Barcelona
country: Spain
facility: 1209
city: Madrid
country: Spain
facility: 1207
city: Madrid
country: Spain
facility: 1210
city: Murcia
country: Spain
facility: 1206
city: Palma de Mallorca
country: Spain
facility: 1204
city: Salamanca
country: Spain
facility: 1208
city: San Sebastián
country: Spain
facility: 1202
city: Valencia
country: Spain
facility: 1205
city: Taipei
country: Taiwan
facility: 1901
city: Taipei
country: Taiwan
facility: 1902
city: Taipei
country: Taiwan
facility: 1903
city: Bournemouth
country: United Kingdom
facility: 1003
city: Bradford
country: United Kingdom
facility: 1004
city: London
country: United Kingdom
facility: 1001
city: Nottingham
country: United Kingdom
facility: 1005
Study officials:
affiliation: Edwards Comprehensive Cancer Center, Marshall University (Huntington)
name: Óscar F. Ballester, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: NY Presbyterian Hosp. - Cornell University - NY
name: Rubén Niesvizky, M.D.
role: PRINCIPAL_INVESTIGATOR
References: