Relapsed/Refractory Multiple MyelomaPhase 3ADMYRENCT01102426
Aplidin - Dexamethasone in Relapsed/Refractory Myeloma
A Phase 3 study testing Plitidepsin and Dexamethasone in people with Relapsed/Refractory Multiple Myeloma, run by PharmaMar at 82 sites in 19 countries.
Trial summary
Study of Plitidepsin in combination with dexamethasone versus dexamethasone alone in patients with relapsed/refractory multiple myeloma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsed/Refractory Multiple Myeloma
- What is being tested?
- Plitidepsin and Dexamethasone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 255 participants
- Where
- 82 sitesin 19 countries
- Study dates
- Jun 2010to Nov 2017
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
82 sites in 19 countries.
82 sites in 19 countries
Spain10 sites
1201
Barcelona
1203
Barcelona
1209
Barcelona
1207
Madrid
1210
Madrid
1206
Murcia
1204
Palma de Mallorca
1208
Salamanca
1202
San Sebastián
1205
Valencia
South Korea9 sites
1502
Anyang
1501
Daejeon
1507
Hwasun
1506
Incheon
1505
Jeonju
1508
Seongnam
1503
Seoul
1504
Seoul
1509
Seoul
Germany8 sites
709
Düsseldorf
705
Essen
706
Frankfurt
707
Frankfurt
708
Freiburg im Breisgau
703
Heidelberg
702
München
704
Würzburg
Australia7 sites
108
Adelaide
102
Canberra
101
Geelong
105
Parkville
106
Perth
104
South Brisbane
109
Woodville
Austria6 sites
202
Graz
204
Innsbruck
203
Salzburg
201
Vienna
205
Vienna
208
Vienna
Italy6 sites
806
Bari
801
Genova
805
Reggio Emilia
803
Rozzano
804
San Giovanni Rotondo
802
Torino
United States5 sites
1104
Canton, Ohio
1105
Jacksonville, Florida
1103
Los Angeles, California
1102
New York, New York
1107
Tuscaloosa, Alabama
United Kingdom4 sites
1003
Bournemouth
1004
Bradford
1001
London
1005
Nottingham
About this study
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 of Plitidepsin in combination with dexamethasone versus dexamethasone alone in patients with relapsed/refractory multiple myeloma.
Read the 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).
- Conditions
- Relapsed/Refractory Multiple Myeloma
- Being tested
- Plitidepsin, Dexamethasone
- Keywords
- Multiple Myeloma, Aplidin, plitidepsin, dexamethasone
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlitidepsinDrug
Also called APLIDIN (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.
DexamethasoneDrug
Also called DXN
4 mg tablet. 40 mg orally on Day 1, 8, 15 and 22 every four weeks.
| Study group | Role | What they receive |
|---|---|---|
| Plitidepsin+Dexamethasone | Experimental | plitidepsin + dexamethasone combination Receives: Drug: Plitidepsin; Drug: Dexamethasone |
| Dexamethasone | Active comparator | dexamethasone single agent Receives: Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival (PFS) as Per Intention-to-treat (ITT)
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).
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Measured: 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
Percentage of Participants With Progression Free Survival (PFS) as Per Intention-to-treat (ITT) at 6 Months
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).
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Measured: 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 (15)
Progression-free Survival (Investigator Assessment)
The secondary study analysis was based on Investigator's assessment PFS data in the ITT efficacy population, defined as all patients randomized to either treatment arm. PFS was calculated from randomization to the first evidence of PD or death due to any cause. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions If the patient received further antitumor therapy before PD and within the timeframe expected for first follow-up, PFS was censored on the date of the last disease assessment prior to the administration of this antitumor therapy.
Measured: 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
Percentage of Participants With Progression-free Survival (Investigator Assessment) at 6 Months
The secondary study analysis was based on Investigator's assessment PFS data in the ITT efficacy population, defined as all patients randomized to either treatment arm. PFS was calculated from randomization to the first evidence of PD or death due to any cause. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions If the patient received further antitumor therapy before PD and within the timeframe expected for first follow-up, PFS was censored on the date of the last disease assessment prior to the administration of this antitumor therapy.
Measured: 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
Overall Survival
Overall Survival (OS) is defined as the time from the date of randomization to the date of death or last contact
Measured: From randomization to the death due to any cause,assessed up to 5 years
Percentage of Participants With Overall Survival at 12 Months
Overall Survival (OS) is defined as the time from the date of randomization to the date of death or last contact
Measured: From randomization to the death due to any cause,assessed up to 12 months
Percentage of Participants With Overall Survival at 24 Months
Overall Survival (OS) is defined as the time from the date of randomization to the date of death or last contact
Measured: From randomization to the death due to any cause,assessed up to 24 months
Duration of Response (Independent Review Committee)
DR was calculated from the date of first documentation of response to the date of disease progression or death. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Measured: From the date of first documentation of response to the date of disease progression or death, assessed up to 5 years
Percentage of Participants With Duration of Response (Independent Review Committee) at 6 Months
DR was calculated from the date of first documentation of response to the date of disease progression or death. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Measured: From the date of first documentation of response to the date of disease progression or death, assessed up to 6 months
Duration of Response (Investigator Assessment)
DR was calculated from the date of first documentation of response to the date of disease progression or death. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Measured: From the date of first documentation of response to the date of disease progression or death, assessed up to 5 years
Percentage of Participants With Duration of Response (Investigator Assessment) at 6 Months
DR was calculated from the date of first documentation of response to the date of disease progression or death. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Measured: From the date of first documentation of response to the date of disease progression or death, assessed up to 6 months
Best Overall Response (Independent Review Committee)
Very good partial response (VGPR) serum and urine M-protein detectable but not electrophoresis or >90% reduction in serum M-protein and urine M-protein <100 mg/24h Partial response (PR) ≥50% reduction in serum M-protein and 90% reduction in 24h urine M-protein or to <200 mg/24h. 50% reduction in size of any soft tissue plasmacytomas Minor response (MR) 25%-49% reduction of serum M-protein and 50-89% reduction of 24h urine M-protein. 25-49% reduction in size of soft tissue plasmacytomas. No increase in size or number of bone lesions Stable disease (SD) No sCR, CR, VGPR, PR, MR or PD Progressive disease (PD) 25% increase from the lowest value: serum M-protein, urine M-protein, BM plasma cell. Increase in size, new bone lesions, soft tissue plasmacytomas or serum calcium >11.5 mg/dL; NE, not evaluable
Measured: From the date of first documentation of response to the date of disease progression or death, assessed up to 5 years
Overall Response Rate (Independent Review Committee)
Overall response rate including sCR, CR, VGPR, PR and MR. Very good partial response (VGPR) serum and urine M-protein detectable but not electrophoresis or >90% reduction in serum M-protein and urine M-protein <100 mg/24h Partial response (PR) ≥50% reduction in serum M-protein and 90% reduction in 24h urine M-protein or to <200 mg/24h. 50% reduction in size of any soft tissue plasmacytomas Minor response (MR) 25%-49% reduction of serum M-protein and 50-89% reduction of 24h urine M-protein. 25-49% reduction in size of soft tissue plasmacytomas. No increase in size or number of bone lesions
Measured: From the date of first documentation of response to the date of disease progression or death, assessed up to 5 years
Overall Response Rate (Independent Review Committee) Excluding MR
Includes sCR, CR, VGPR and PR (excludes MR). Very good partial response (VGPR) serum and urine M-protein detectable but not electrophoresis or >90% reduction in serum M-protein and urine M-protein <100 mg/24h Partial response (PR) ≥50% reduction in serum M-protein and 90% reduction in 24h urine M-protein or to <200 mg/24h. 50% reduction in size of any soft tissue plasmacytomas
Measured: From the date of first documentation of response to the date of disease progression or death, assessed up to 5 years
Best Overall Response (Investigator Assessment)
Very good partial response (VGPR) serum and urine M-protein detectable but not electrophoresis or >90% reduction in serum M-protein and urine M-protein <100 mg/24h Partial response (PR) ≥50% reduction in serum M-protein and 90% reduction in 24h urine M-protein or to <200 mg/24h. 50% reduction in size of any soft tissue plasmacytomas Minor response (MR) 25%-49% reduction of serum M-protein and 50-89% reduction of 24h urine M-protein. 25-49% reduction in size of soft tissue plasmacytomas. No increase in size or number of bone lesions Stable disease (SD) No sCR, CR, VGPR, PR, MR or PD Progressive disease (PD) 25% increase from the lowest value: serum M-protein, urine M-protein, BM plasma cell. Increase in size, new bone lesions, soft tissue plasmacytomas or serum calcium >11.5 mg/dL; NE, not evaluable
Measured: From the date of first documentation of response to the date of disease progression or death, assessed up to 5 years
Overall Response Rate (Investigator Assessment)
Includes sCR, CR, VGPR, PR and MR. Very good partial response (VGPR) serum and urine M-protein detectable but not electrophoresis or >90% reduction in serum M-protein and urine M-protein <100 mg/24h Partial response (PR) ≥50% reduction in serum M-protein and 90% reduction in 24h urine M-protein or to <200 mg/24h. 50% reduction in size of any soft tissue plasmacytomas Minor response (MR) 25%-49% reduction of serum M-protein and 50-89% reduction of 24h urine M-protein. 25-49% reduction in size of soft tissue plasmacytomas. No increase in size or number of bone lesions
Measured: From the date of first documentation of response to the date of disease progression or death, assessed up to 5 years
Overall Response Rate (Investigator Assessment) Excluding MR
Very good partial response (VGPR) serum and urine M-protein detectable but not electrophoresis or >90% reduction in serum M-protein and urine M-protein <100 mg/24h Partial response (PR) ≥50% reduction in serum M-protein and 90% reduction in 24h urine M-protein or to <200 mg/24h. 50% reduction in size of any soft tissue plasmacytomas
Measured: From the date of first documentation of response to the date of disease progression or death, assessed up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2010 (estimated)
- Study startJun 2010
- Primary completionNov 2017
- Study completionNov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Relapsed/Refractory Multiple MyelomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 255 participants (actual)
Sponsor and investigators
- Lead sponsor
- PharmaMar
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Óscar F. Ballester, M.D., Principal investigator, Edwards Comprehensive Cancer Center, Marshall University (Huntington)Rubén Niesvizky, M.D., Principal investigator, NY Presbyterian Hosp. - Cornell University - NY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01102426
- Sponsor's protocol ID
- APL-C-001-09
- Acronym
- ADMYRE
- Status last verified
- Oct 2020
- First submitted
- 31 Mar 2010
- Last updated
- 10 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01102426
- Acronym / sponsor ID
- ADMYRE / APL-C-001-09
- Conditions
- Relapsed/Refractory Multiple Myeloma
- Keywords
- Multiple Myeloma, Aplidin, plitidepsin, dexamethasone
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 255 participants (actual)
- Lead sponsor
- PharmaMarIndustry (pharma, biotech, devices)
- Study start
- Jun 2010
- Primary completion
- Nov 2017 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 13 Apr 2010 (estimated)
- Results
- Posted 22 Oct 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Plitidepsin+Dexamethasone | Experimental | Drug: Plitidepsin, Drug: Dexamethasoneplitidepsin + dexamethasone combination |
| Dexamethasone | Active comparator | Drug: Dexamethasonedexamethasone single agent |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlitidepsinAlso: APLIDIN (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. | Drug | Plitidepsin+Dexamethasone |
| DexamethasoneAlso: DXN4 mg tablet. 40 mg orally on Day 1, 8, 15 and 22 every four weeks. | Drug | Dexamethasone, Plitidepsin+Dexamethasone |
Primary outcome
Progression Free Survival (PFS) as Per Intention-to-treat (ITT)
Time frame: 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
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). Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Percentage of Participants With Progression Free Survival (PFS) as Per Intention-to-treat (ITT) at 6 Months
Time frame: 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
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). Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
15 secondary outcomes
Progression-free Survival (Investigator Assessment)
Time frame: 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
Percentage of Participants With Progression-free Survival (Investigator Assessment) at 6 Months
Time frame: 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
Overall Survival
Time frame: From randomization to the death due to any cause,assessed up to 5 years
Percentage of Participants With Overall Survival at 12 Months
Time frame: From randomization to the death due to any cause,assessed up to 12 months
Percentage of Participants With Overall Survival at 24 Months
Time frame: From randomization to the death due to any cause,assessed up to 24 months
Duration of Response (Independent Review Committee)
Time frame: From the date of first documentation of response to the date of disease progression or death, assessed up to 5 years
Percentage of Participants With Duration of Response (Independent Review Committee) at 6 Months
Time frame: From the date of first documentation of response to the date of disease progression or death, assessed up to 6 months
Duration of Response (Investigator Assessment)
Time frame: From the date of first documentation of response to the date of disease progression or death, assessed up to 5 years
Percentage of Participants With Duration of Response (Investigator Assessment) at 6 Months
Time frame: From the date of first documentation of response to the date of disease progression or death, assessed up to 6 months
Best Overall Response (Independent Review Committee)
Time frame: From the date of first documentation of response to the date of disease progression or death, assessed up to 5 years
Overall Response Rate (Independent Review Committee)
Time frame: From the date of first documentation of response to the date of disease progression or death, assessed up to 5 years
Overall Response Rate (Independent Review Committee) Excluding MR
Time frame: From the date of first documentation of response to the date of disease progression or death, assessed up to 5 years
Best Overall Response (Investigator Assessment)
Time frame: From the date of first documentation of response to the date of disease progression or death, assessed up to 5 years
Overall Response Rate (Investigator Assessment)
Time frame: From the date of first documentation of response to the date of disease progression or death, assessed up to 5 years
Overall Response Rate (Investigator Assessment) Excluding MR
Time frame: From the date of first documentation of response to the date of disease progression or death, assessed up to 5 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Óscar F. Ballester, M.D. principal investigator
Edwards Comprehensive Cancer Center, Marshall University (Huntington)
Rubén Niesvizky, M.D. principal investigator
NY Presbyterian Hosp. - Cornell University - NY
82 sites in 19 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Plitidepsin and Dexamethasone in people with Relapsed/Refractory Multiple Myeloma, run by PharmaMar at 82 sites in 19 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 82 sites in Spain, South Korea, Germany, Australia, Austria and 14 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Oct 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival (PFS) as Per Intention-to-treat (ITT) (time frame: 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2020.