NCT01102426 · REGISTRY CONDITION SEARCH

Aplidin - Dexamethasone in Relapsed/Refractory Myeloma

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE3
Status at capture: COMPLETED
Registry last update: 2020-11-10

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

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Progression Free Survival (PFS) as Per Intention-to-treat (ITT)

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outcome · POSTED

Percentage of Participants With Progression Free Survival (PFS) as Per Intention-to-treat (ITT) at 6 Months

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outcome · POSTED

Progression-free Survival (Investigator Assessment)

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outcome · POSTED

Percentage of Participants With Progression-free Survival (Investigator Assessment) at 6 Months

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outcome · POSTED

Overall Survival

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outcome · POSTED

Percentage of Participants With Overall Survival at 12 Months

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outcome · POSTED

Percentage of Participants With Overall Survival at 24 Months

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outcome · POSTED

Duration of Response (Independent Review Committee)

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outcome · POSTED

Percentage of Participants With Duration of Response (Independent Review Committee) at 6 Months

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outcome · POSTED

Duration of Response (Investigator Assessment)

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outcome · POSTED

Percentage of Participants With Duration of Response (Investigator Assessment) at 6 Months

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outcome · POSTED

Best Overall Response (Independent Review Committee)

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outcome · POSTED

Overall Response Rate (Independent Review Committee)

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outcome · POSTED

Overall Response Rate (Independent Review Committee) Excluding MR

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outcome · POSTED

Best Overall Response (Investigator Assessment)

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outcome · POSTED

Overall Response Rate (Investigator Assessment)

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outcome · POSTED

Overall Response Rate (Investigator Assessment) Excluding MR

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

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
healthy Volunteers: false
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
plitidepsin + dexamethasone combination
intervention Names
Drug: Plitidepsin
Drug: Dexamethasone
label
Plitidepsin+Dexamethasone
type
EXPERIMENTAL
description
dexamethasone single agent
intervention Names
Drug: Dexamethasone
label
Dexamethasone
type
ACTIVE_COMPARATOR

interventions

arm Group Labels
Plitidepsin+Dexamethasone
description
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.
name
Plitidepsin
other Names
APLIDIN (plitidepsin)
type
DRUG
arm Group Labels
Dexamethasone
Plitidepsin+Dexamethasone
description
4 mg tablet. 40 mg orally on Day 1, 8, 15 and 22 every four weeks.
name
Dexamethasone
other Names
DXN
type
DRUG

Study design

allocation

RANDOMIZED

intervention Model

PARALLEL

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 255
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

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). 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
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
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). 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
measure
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

secondary Outcomes

description
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.
measure
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
description
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.
measure
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
description
Overall Survival (OS) is defined as the time from the date of randomization to the date of death or last contact
measure
Overall Survival
time Frame
From randomization to the death due to any cause,assessed up to 5 years
description
Overall Survival (OS) is defined as the time from the date of randomization to the date of death or last contact
measure
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
description
Overall Survival (OS) is defined as the time from the date of randomization to the date of death or last contact
measure
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
description
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
measure
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
description
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
measure
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
description
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
measure
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
description
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
measure
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
description
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
measure
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
description
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
measure
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
description
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
measure
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

Full study description

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).

Source references

Source notices and limitations

Discovery and provenance

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exact text
NCT01102426
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query cond
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query disease state id
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source file
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source url
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Preserved source evidence · Not medical advice