NCT00064038 · STUDY IN CONTEXT

S0232 Dexamethasone With or Without Lenalidomide in Treating Patients With Previously Untreated Stage I, Stage II, or Stage III Multiple Myeloma

Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. 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

Progression is defined as a \> 25% increase from baseline in myeloma protein production or other signs of disease progression such as hypercalcemia, etc. In patients with a confirmed Partial Remission, Remission, or Complete Remission, relapse is defined as the first occurrence of any of the following: 1) a myeloma protein increase by than 100% from the lowest level recorded on study, provided the absolute magnitude of this increase is at least 1g/dL for a serum monoclonal protein or at least 500 mg/24 hrs of urine M-protein; 2) a myeloma protein increase above the response criteria for Partial Remission, with the same requirements for the absolute magnitude of the protein increase; 3)reappearance of any myeloma peak that had disappeared while on protocol treatment, provided it meets the same requirements listed above; 4) increase in the size and number of lytic bone lesions recognized on radiographs.

Source null

→

secondary · POSTED

Compare the toxicity profile of these regimens, including thrombotic complications, in these patients, based on CTCAE v. 3.0.

All participants receiving at least one dose of induction therapy

→

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-plasma-cell-neoplasms
nct id: NCT00064038
trial label: S0232 Dexamethasone With or Without Lenalidomide in Treating Patients With Previously Untreated Stage I, Stage II, or Stage III Multiple Myeloma
applicability: narrower
applicability note: Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded.
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: 2
harms Count: 3
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-plasma-cell-neoplasms
nct id
NCT00064038
outcome key
om-0001
source section id
NCT00064038-om-0001
source outcome index
1
endpoint
Progression-Free Survival
endpoint definition
Progression is defined as a \> 25% increase from baseline in myeloma protein production or other signs of disease progression such as hypercalcemia, etc. In patients with a confirmed Partial Remission, Remission, or Complete Remission, relapse is defined as the first occurrence of any of the following: 1) a myeloma protein increase by than 100% from the lowest level recorded on study, provided the absolute magnitude of this increase is at least 1g/dL for a serum monoclonal protein or at least 500 mg/24 hrs of urine M-protein; 2) a myeloma protein increase above the response criteria for Partial Remission, with the same requirements for the absolute magnitude of the protein increase; 3)reappearance of any myeloma peak that had disappeared while on protocol treatment, provided it meets the same requirements listed above; 4) increase in the size and number of lytic bone lesions recognized on radiographs.
time origin
From date of initial registration to date of progression/relapse of disease or death from any cause, whichever came first, up to 5 years
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population 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-plasma-cell-neoplasms
nct id
NCT00064038
outcome key
om-0000
source section id
NCT00064038-om-0000
source outcome index
0
endpoint
Toxicity
endpoint definition
Compare the toxicity profile of these regimens, including thrombotic complications, in these patients, based on CTCAE v. 3.0.
time origin
From time of initiating study treatment until discontinuation of study treatment or of open-label REVLIMID + LOW DOSE DEX, whichever comes last, up to 5 years
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
All participants receiving at least one dose of induction therapy
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-plasma-cell-neoplasms
nct id
NCT00064038
outcome key
om-0000
arm key
OG000
arm label
Lenalidomide and Dexamethasone
regimen
Patients receive induction therapy comprising oral dexamethasone (DM) on days 1-4, 9-12, and 17-20 and oral lenalidomide on days 1-28. Treatment repeats every 35 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance therapy comprising oral DM on days 1-4 and 15-18 and oral lenalidomide on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
analyzed count
96
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00064038-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-plasma-cell-neoplasms
nct id
NCT00064038
outcome key
om-0000
arm key
OG001
arm label
Dexamethasone
regimen
Patients receive induction therapy comprising DM as in arm I induction and oral placebo on days 1-28. Treatment repeats as in arm I induction. Some patients may then receive maintenance therapy comprising oral DM as in arm I maintenance and oral placebo on days 1-21. Courses repeat as in arm I maintenance.
analyzed count
94
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00064038-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-plasma-cell-neoplasms
nct id
NCT00064038
outcome key
om-0000
arm key
OG002
arm label
Crossover to Rev+Dex
regimen
Patients receive induction therapy comprising oral dexamethasone (DM) on days 1-4, 9-12, and 17-20 and oral lenalidomide on days 1-28. Treatment repeats every 35 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance therapy comprising oral DM on days 1-4 and 15-18 and oral lenalidomide on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
analyzed count
40
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00064038-om-0000#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-plasma-cell-neoplasms
nct id
NCT00064038
outcome key
om-0001
arm key
OG000
arm label
Lenalidomide+Dexamethasone
regimen
Patients receive induction therapy comprising oral dexamethasone (DM) on days 1-4, 9-12, and 17-20 and oral lenalidomide on days 1-28. Treatment repeats every 35 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance therapy comprising oral DM on days 1-4 and 15-18 and oral lenalidomide on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
analyzed count
97
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00064038-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-plasma-cell-neoplasms
nct id
NCT00064038
outcome key
om-0001
arm key
OG001
arm label
Dexamethasone
regimen
Patients receive induction therapy comprising DM as in arm I induction and oral placebo on days 1-28. Treatment repeats as in arm I induction. Some patients may then receive maintenance therapy comprising oral DM as in arm I maintenance and oral placebo on days 1-21. Courses repeat as in arm I maintenance.
analyzed count
95
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00064038-om-0001#groups/OG001

harms

release id
clinical-indications-draft-1
disease state id
ds-plasma-cell-neoplasms
nct id
NCT00064038
harm key
EG000
source section id
NCT00064038-ae
event group key
EG000
event group label
Lenalidomide and Dexamethasone
serious affected
41
serious at risk
96
other affected
91
other at risk
96
frequency threshold
5
collection period
Report through 1/13/2009 to match data reported in MS.
event definition
Source null
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-plasma-cell-neoplasms
nct id
NCT00064038
harm key
EG001
source section id
NCT00064038-ae
event group key
EG001
event group label
Dexamethasone
serious affected
21
serious at risk
94
other affected
90
other at risk
94
frequency threshold
5
collection period
Report through 1/13/2009 to match data reported in MS.
event definition
Source null
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-plasma-cell-neoplasms
nct id
NCT00064038
harm key
EG002
source section id
NCT00064038-ae
event group key
EG002
event group label
Crossover to Rev+Dex
serious affected
14
serious at risk
40
other affected
39
other at risk
40
frequency threshold
5
collection period
Report through 1/13/2009 to match data reported in MS.
event definition
Source null
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