NCT00229203 · STUDY IN CONTEXT

A Study of Aplidin (Plitidepsin) 3 h iv in Subjects With Relapsing or Refractory Multiple Myeloma

Draft scope assessment: unclear. Attached because the study's own record describes refractory disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

Complete response(CR):0 percentage the original monoclonal protein level from blood and urine Partial response(PR): ≥50 percentage reduction in the level of serum monoclonal protein Minimal response(MR):≥25 percentage to ≤ 49 percentage reduction in the level of serum monoclonal protein Stable disease: Not meeting the criteria for MR or PD. Progressive disease: \>25 percentage increase in level of serum monoclonal paraprotein, which must also be an absolute increase of at least 5 g/L and confirmed on a repeat investigation. Treatmen failure: Reappearance of serum or urinary paraprotein

Per protocol - Only 29 of 32 and 18 of 19 enrolled patients were evaluable (analyzed patients)

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secondary · POSTED

Time to Progression (TTP):date of first infusion to the date of documented progressive disease which can be defined as \>25 percentage increase in level of serum monoclonal paraprotein.

Per protocol - Only 29 of 32 and 18 of 19 enrolled patients were evaluable (analyzed patients)

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secondary · POSTED

Progression Free Survival (PFS): time from the date of first infusion to the date of documented progression or death

Per protocol - Only 21 of 32 and 8 of 19 enrolled patients were evaluable (analyzed patients)

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secondary · POSTED

Overall Survival (OS): time from the date of first infusion to the date of documented death

Per protocol - Only 21 of 32 and 8 of 19 enrolled patients were evaluable (analyzed patients. For patient of group plitidepsin + dexamethasone the median overall survival could not be calculated due to follow-up short duration. The survival rates at 6 and 12 months are provided instead.

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Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record

trial

release id: clinical-indications-draft-1
disease state id: ds-multiple-myeloma-refractory-b00a2fc0
nct id: NCT00229203
trial label: A Study of Aplidin (Plitidepsin) 3 h iv in Subjects With Relapsing or Refractory Multiple Myeloma
applicability: unclear
applicability note: Attached because the study's own record describes refractory disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z
provenance class: registry-condition-search
discovery note: Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
outcome Count: 4
harms Count: 2
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-multiple-myeloma-refractory-b00a2fc0
nct id
NCT00229203
outcome key
om-0000
source section id
NCT00229203-om-0000
source outcome index
0
endpoint
Objective Response Rate (ORR), Defined as the Combined Rate of Complete Response, Partial Response and Minimal Response
endpoint definition
Complete response(CR):0 percentage the original monoclonal protein level from blood and urine Partial response(PR): ≥50 percentage reduction in the level of serum monoclonal protein Minimal response(MR):≥25 percentage to ≤ 49 percentage reduction in the level of serum monoclonal protein Stable disease: Not meeting the criteria for MR or PD. Progressive disease: \>25 percentage increase in level of serum monoclonal paraprotein, which must also be an absolute increase of at least 5 g/L and confirmed on a repeat investigation. Treatmen failure: Reappearance of serum or urinary paraprotein
time origin
Every 2 weeks until progression or death occurs.
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Per protocol - Only 29 of 32 and 18 of 19 enrolled patients were evaluable (analyzed patients)
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-multiple-myeloma-refractory-b00a2fc0
nct id
NCT00229203
outcome key
om-0001
source section id
NCT00229203-om-0001
source outcome index
1
endpoint
Time to Progression (TTP)
endpoint definition
Time to Progression (TTP):date of first infusion to the date of documented progressive disease which can be defined as \>25 percentage increase in level of serum monoclonal paraprotein.
time origin
Every 2 weeks until progression or death due to progression occurs. Median TTP and TTP rates at 3 months and 6 months were assessed.
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Per protocol - Only 29 of 32 and 18 of 19 enrolled patients were evaluable (analyzed patients)
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-multiple-myeloma-refractory-b00a2fc0
nct id
NCT00229203
outcome key
om-0002
source section id
NCT00229203-om-0002
source outcome index
2
endpoint
Progression Free Survival (PFS)
endpoint definition
Progression Free Survival (PFS): time from the date of first infusion to the date of documented progression or death
time origin
Every 2 weeks until progression or death occurs. Median PFS and PFS rates at 3 months and 6 months were assessed.
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Per protocol - Only 21 of 32 and 8 of 19 enrolled patients were evaluable (analyzed patients)
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-multiple-myeloma-refractory-b00a2fc0
nct id
NCT00229203
outcome key
om-0003
source section id
NCT00229203-om-0003
source outcome index
3
endpoint
Number of Patients With Overall Survival (OS)
endpoint definition
Overall Survival (OS): time from the date of first infusion to the date of documented death
time origin
Start of treatment to death. At each patient visit while on treatment, then every 3m during follow-up. Median OS and OS rates at 6 months and 12 months were assessed.
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Per protocol - Only 21 of 32 and 8 of 19 enrolled patients were evaluable (analyzed patients. For patient of group plitidepsin + dexamethasone the median overall survival could not be calculated due to follow-up short duration. The survival rates at 6 and 12 months are provided instead.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

arms

release id
clinical-indications-draft-1
disease state id
ds-multiple-myeloma-refractory-b00a2fc0
nct id
NCT00229203
outcome key
om-0000
arm key
OG000
arm label
Plitidepsin
regimen
Plitidepsin 5 mg/m2 given as a 3-hour i.v. infusion every two weeks.
analyzed count
29
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00229203-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-multiple-myeloma-refractory-b00a2fc0
nct id
NCT00229203
outcome key
om-0000
arm key
OG001
arm label
Plitidepsin + Dexamethasone
regimen
Plitidepsin 5 mg/m2 given as a 3-hour i.v. infusion every two weeks plus 20 mg of oral dexamethasone every day on days 1 to 4 of each cycle, starting at the same time than the plitidepsin infusion.
analyzed count
18
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00229203-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-multiple-myeloma-refractory-b00a2fc0
nct id
NCT00229203
outcome key
om-0001
arm key
OG000
arm label
Plitidepsin
regimen
Plitidepsin 5 mg/m2 given as a 3-hour i.v. infusion every two weeks.
analyzed count
29
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00229203-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-multiple-myeloma-refractory-b00a2fc0
nct id
NCT00229203
outcome key
om-0001
arm key
OG001
arm label
Plitidepsin + Dexamethasone
regimen
Plitidepsin 5 mg/m2 given as a 3-hour i.v. infusion every two weeks plus 20 mg of oral dexamethasone every day on days 1 to 4 of each cycle, starting at the same time than the plitidepsin infusion.
analyzed count
18
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00229203-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-multiple-myeloma-refractory-b00a2fc0
nct id
NCT00229203
outcome key
om-0002
arm key
OG000
arm label
Plitidepsin
regimen
Plitidepsin 5 mg/m2 given as a 3-hour i.v. infusion every two weeks.
analyzed count
21
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00229203-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-multiple-myeloma-refractory-b00a2fc0
nct id
NCT00229203
outcome key
om-0002
arm key
OG001
arm label
Plitidepsin + Dexamethasone
regimen
Plitidepsin 5 mg/m2 given as a 3-hour i.v. infusion every two weeks plus 20 mg of oral dexamethasone every day on days 1 to 4 of each cycle, starting at the same time than the plitidepsin infusion.
analyzed count
8
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00229203-om-0002#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-multiple-myeloma-refractory-b00a2fc0
nct id
NCT00229203
outcome key
om-0003
arm key
OG000
arm label
Plitidepsin
regimen
Plitidepsin 5 mg/m2 given as a 3-hour i.v. infusion every two weeks.
analyzed count
21
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00229203-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-multiple-myeloma-refractory-b00a2fc0
nct id
NCT00229203
outcome key
om-0003
arm key
OG001
arm label
Plitidepsin + Dexamethasone
regimen
Plitidepsin 5 mg/m2 given as a 3-hour i.v. infusion every two weeks plus 20 mg of oral dexamethasone every day on days 1 to 4 of each cycle, starting at the same time than the plitidepsin infusion.
analyzed count
8
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00229203-om-0003#groups/OG001

harms

release id
clinical-indications-draft-1
disease state id
ds-multiple-myeloma-refractory-b00a2fc0
nct id
NCT00229203
harm key
EG000
source section id
NCT00229203-ae
event group key
EG000
event group label
Plitidepsin
serious affected
32
serious at risk
51
other affected
51
other at risk
51
frequency threshold
5
collection period
Source null
event definition
32 patients were treated with plitidepsin as single agent;afterwards 19 of them were treated with plitidepsin+dexamethasone combination.Therefore 32+19=51 is the no. patients at risk for plitidepsin and 19 is no. of patients at risk for dexamethasone
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-multiple-myeloma-refractory-b00a2fc0
nct id
NCT00229203
harm key
EG001
source section id
NCT00229203-ae
event group key
EG001
event group label
Plitidepsin + Dexamethasone
serious affected
11
serious at risk
19
other affected
19
other at risk
19
frequency threshold
5
collection period
Source null
event definition
32 patients were treated with plitidepsin as single agent;afterwards 19 of them were treated with plitidepsin+dexamethasone combination.Therefore 32+19=51 is the no. patients at risk for plitidepsin and 19 is no. of patients at risk for dexamethasone
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

quality of life

setting source links

Preserved source evidence · Not medical advice