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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01102426




Registration number
NCT01102426
Ethics application status
Date submitted
31/03/2010
Date registered
13/04/2010
Date last updated
10/11/2020

Titles & IDs
Public title
Aplidin - Dexamethasone in Relapsed/Refractory Myeloma
Scientific title
Randomized, Multicenter, Open-label, Phase III Study of Plitidepsin in Combination With Dexamethasone vs. Dexamethasone Alone in Patients With Relapsed/Refractory Multiple Myeloma
Secondary ID [1] 0 0
APL-C-001-09
Universal Trial Number (UTN)
Trial acronym
ADMYRE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Relapsed/Refractory Multiple Myeloma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Other cancer types

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Plitidepsin
Treatment: Drugs - Dexamethasone

Experimental: Plitidepsin+Dexamethasone - plitidepsin + dexamethasone combination

Active Comparator: Dexamethasone - dexamethasone single agent


Treatment: Drugs: Plitidepsin
plitidepsin: powder and solvent for concentrate for solution for infusion. 2 mg vial + 4 ml ampoule. 5 mg/m2 intravenously (i.v.) over three hours on Day 1 and 15 every 4 weeks. dexamethasone: 4 mg tablet. 40 mg orally on Day 1, 8, 15 and 22 every four weeks at least one hour before plitidepsin infusion.

Treatment: Drugs: Dexamethasone
4 mg tablet. 40 mg orally on Day 1, 8, 15 and 22 every four weeks.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression Free Survival (PFS) as Per Intention-to-treat (ITT)
Timepoint [1] 0 0
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
Primary outcome [2] 0 0
Percentage of Participants With Progression Free Survival (PFS) as Per Intention-to-treat (ITT) at 6 Months
Timepoint [2] 0 0
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 outcome [1] 0 0
Progression-free Survival (Investigator Assessment)
Timepoint [1] 0 0
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
Secondary outcome [2] 0 0
Percentage of Participants With Progression-free Survival (Investigator Assessment) at 6 Months
Timepoint [2] 0 0
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 outcome [3] 0 0
Overall Survival
Timepoint [3] 0 0
From randomization to the death due to any cause,assessed up to 5 years
Secondary outcome [4] 0 0
Percentage of Participants With Overall Survival at 12 Months
Timepoint [4] 0 0
From randomization to the death due to any cause,assessed up to 12 months
Secondary outcome [5] 0 0
Percentage of Participants With Overall Survival at 24 Months
Timepoint [5] 0 0
From randomization to the death due to any cause,assessed up to 24 months
Secondary outcome [6] 0 0
Duration of Response (Independent Review Committee)
Timepoint [6] 0 0
From the date of first documentation of response to the date of disease progression or death, assessed up to 5 years
Secondary outcome [7] 0 0
Percentage of Participants With Duration of Response (Independent Review Committee) at 6 Months
Timepoint [7] 0 0
From the date of first documentation of response to the date of disease progression or death, assessed up to 6 months
Secondary outcome [8] 0 0
Duration of Response (Investigator Assessment)
Timepoint [8] 0 0
From the date of first documentation of response to the date of disease progression or death, assessed up to 5 years
Secondary outcome [9] 0 0
Percentage of Participants With Duration of Response (Investigator Assessment) at 6 Months
Timepoint [9] 0 0
From the date of first documentation of response to the date of disease progression or death, assessed up to 6 months
Secondary outcome [10] 0 0
Best Overall Response (Independent Review Committee)
Timepoint [10] 0 0
From the date of first documentation of response to the date of disease progression or death, assessed up to 5 years
Secondary outcome [11] 0 0
Overall Response Rate (Independent Review Committee)
Timepoint [11] 0 0
From the date of first documentation of response to the date of disease progression or death, assessed up to 5 years
Secondary outcome [12] 0 0
Overall Response Rate (Independent Review Committee) Excluding MR
Timepoint [12] 0 0
From the date of first documentation of response to the date of disease progression or death, assessed up to 5 years
Secondary outcome [13] 0 0
Best Overall Response (Investigator Assessment)
Timepoint [13] 0 0
From the date of first documentation of response to the date of disease progression or death, assessed up to 5 years
Secondary outcome [14] 0 0
Overall Response Rate (Investigator Assessment)
Timepoint [14] 0 0
From the date of first documentation of response to the date of disease progression or death, assessed up to 5 years
Secondary outcome [15] 0 0
Overall Response Rate (Investigator Assessment) Excluding MR
Timepoint [15] 0 0
From the date of first documentation of response to the date of disease progression or death, assessed up to 5 years

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/11/2017
Sample size
Target
Accrual to date
Final
255
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
108 - Adelaide
Recruitment hospital [2] 0 0
102 - Canberra
Recruitment hospital [3] 0 0
101 - Geelong
Recruitment hospital [4] 0 0
105 - Parkville
Recruitment hospital [5] 0 0
106 - Perth
Recruitment hospital [6] 0 0
104 - South Brisbane
Recruitment hospital [7] 0 0
109 - Woodville
Recruitment postcode(s) [1] 0 0
- Adelaide
Recruitment postcode(s) [2] 0 0
- Canberra
Recruitment postcode(s) [3] 0 0
- Geelong
Recruitment postcode(s) [4] 0 0
- Parkville
Recruitment postcode(s) [5] 0 0
- Perth
Recruitment postcode(s) [6] 0 0
- South Brisbane
Recruitment postcode(s) [7] 0 0
- Woodville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
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United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
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United States of America
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New York
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United States of America
State/province [5] 0 0
Ohio
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Austria
State/province [6] 0 0
Graz
Country [7] 0 0
Austria
State/province [7] 0 0
Innsbruck
Country [8] 0 0
Austria
State/province [8] 0 0
Salzburg
Country [9] 0 0
Austria
State/province [9] 0 0
Wien
Country [10] 0 0
Belgium
State/province [10] 0 0
Brugge
Country [11] 0 0
Belgium
State/province [11] 0 0
Brussels
Country [12] 0 0
Belgium
State/province [12] 0 0
Gent
Country [13] 0 0
Czechia
State/province [13] 0 0
Brno
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Czechia
State/province [14] 0 0
Hradec Kralove
Country [15] 0 0
Czechia
State/province [15] 0 0
Praha
Country [16] 0 0
France
State/province [16] 0 0
Lille
Country [17] 0 0
France
State/province [17] 0 0
Nantes
Country [18] 0 0
France
State/province [18] 0 0
Rouen
Country [19] 0 0
France
State/province [19] 0 0
Vandœuvre-lès-Nancy
Country [20] 0 0
Germany
State/province [20] 0 0
Düsseldorf
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Germany
State/province [21] 0 0
Essen
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Germany
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Frankfurt
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Germany
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Freiburg
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Heidelberg
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Munchen
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Würzburg
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Athens
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Patras
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Greece
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Thessaloniki
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Ireland
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Dublin
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Bari
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Genova
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Reggio Emilia
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Rozzano
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Italy
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San Giovanni Rotondo
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Italy
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Torino
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Korea, Republic of
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Anyang
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Korea, Republic of
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Daejeon
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Korea, Republic of
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Hwasun
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Korea, Republic of
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Incheon
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Korea, Republic of
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Jeonju
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Korea, Republic of
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Seongnam
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Korea, Republic of
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Seoul
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Netherlands
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Rotterdam
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New Zealand
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Christchurch
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New Zealand
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Takapuna
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Poland
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Opole
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Poland
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Warszawa
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Portugal
State/province [49] 0 0
Braga
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Portugal
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Porto
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Puerto Rico
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San Juan
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Barcelona
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Madrid
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Murcia
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Palma de Mallorca
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Spain
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Salamanca
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Spain
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San Sebastián
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Spain
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Valencia
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Taiwan
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Taipei
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United Kingdom
State/province [60] 0 0
Bournemouth
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United Kingdom
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Bradford
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London
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United Kingdom
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Nottingham

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
PharmaMar
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Study of Plitidepsin in combination with dexamethasone versus dexamethasone alone in patients
with relapsed/refractory multiple myeloma.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01102426
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Óscar F. Ballester, M.D.
Address 0 0
Edwards Comprehensive Cancer Center, Marshall University (Huntington)
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries