NCT00064337 · STUDY IN CONTEXT

S0115, High-Dose Melphalan and Autologous Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma or Primary Systemic Amyloidosis

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

Time from initial registration until death or date of last contact, whichever occurs first, for up to 5 years from the date of the last patient registration.

Eligible and analyzable patients only.

→

secondary · POSTED

Hematologic Response

Source null

→

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
nct id: NCT00064337
trial label: S0115, High-Dose Melphalan and Autologous Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma or Primary Systemic Amyloidosis
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-multiple-myeloma
nct id
NCT00064337
outcome key
om-0000
source section id
NCT00064337-om-0000
source outcome index
0
endpoint
Overall Survival
endpoint definition
Time from initial registration until death or date of last contact, whichever occurs first, for up to 5 years from the date of the last patient registration.
time origin
5 years from initial registration, or until death, whichever occurred earlier, on average, about 4.5 years
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Eligible and analyzable patients only.
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
nct id
NCT00064337
outcome key
om-0001
source section id
NCT00064337-om-0001
source outcome index
1
endpoint
Hematologic Response
endpoint definition
Hematologic Response
time origin
Until off study
analysis role
secondary
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

arms

release id
clinical-indications-draft-1
disease state id
ds-multiple-myeloma
nct id
NCT00064337
outcome key
om-0000
arm key
OG000
arm label
Treatment
regimen
MM Induction: dexamethasone 20mg/d PO Days 1-4, 9-12 and 17-20 every 35 days for 2 cycles and thalidomide 200 mg/d PO Days 1-70. Mobilization and SC Collection: MM, MM+AL, MM+LCD: cyclophosphamide 2.5 gm/m2 IV Day 1; mesna 800 mg/m2 IV Day 1 x 3 doses; G-CSF 10 mcg/kg/d SQ Day 2 through day prior to last leukapheresis. Amyloid or LCDD-Only: G-CSF 16 mcg/kg/d SQ Days 1-3 (continued daily until the day prior to the last day of stem cell collection). Conditioning/Transplant - Modified HighDose Melphalan (given for both transplants): melphalan 100 mg/m2/d IV over 20 mins Day -2; PBSC infusion \>/= 3.5 x 10\^6 CD34+ cells/kg IV Day 0. Maintenance (MM only): dexamethasone 40 mg/d PO Days 1-4 every 28 days and thalidomide 100 mg/d PO daily - given for one year, followed by dexamethasone 40 mg/d PO Days 1-4 every 28 days and thalidomide 100 mg/d PO daily - given for one year. filgrastim cyclophosphamide dexamethasone melphalan thalidomide peripheral blood
analyzed count
93
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00064337-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-multiple-myeloma
nct id
NCT00064337
outcome key
om-0001
arm key
OG000
arm label
Treatment
regimen
MM Induction: dexamethasone 20mg/d PO Days 1-4, 9-12 and 17-20 every 35 days for 2 cycles and thalidomide 200 mg/d PO Days 1-70. Mobilization and SC Collection: MM, MM+AL, MM+LCD: cyclophosphamide 2.5 gm/m2 IV Day 1; mesna 800 mg/m2 IV Day 1 x 3 doses; G-CSF 10 mcg/kg/d SQ Day 2 through day prior to last leukapheresis. Amyloid or LCDD-Only: G-CSF 16 mcg/kg/d SQ Days 1-3 (continued daily until the day prior to the last day of stem cell collection). Conditioning/Transplant - Modified HighDose Melphalan (given for both transplants): melphalan 100 mg/m2/d IV over 20 mins Day -2; PBSC infusion \>/= 3.5 x 10\^6 CD34+ cells/kg IV Day 0. Maintenance (MM only): dexamethasone 40 mg/d PO Days 1-4 every 28 days and thalidomide 100 mg/d PO daily - given for one year, followed by dexamethasone 40 mg/d PO Days 1-4 every 28 days and thalidomide 100 mg/d PO daily - given for one year.
analyzed count
23
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00064337-om-0001#groups/OG000

harms

release id
clinical-indications-draft-1
disease state id
ds-multiple-myeloma
nct id
NCT00064337
harm key
EG000
source section id
NCT00064337-ae
event group key
EG000
event group label
PBSCC or Induction/PBSCC
serious affected
4
serious at risk
92
other affected
83
other at risk
92
frequency threshold
5
collection period
Source null
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-multiple-myeloma
nct id
NCT00064337
harm key
EG001
source section id
NCT00064337-ae
event group key
EG001
event group label
Autologous Transplants
serious affected
3
serious at risk
65
other affected
62
other at risk
65
frequency threshold
5
collection period
Source null
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-multiple-myeloma
nct id
NCT00064337
harm key
EG002
source section id
NCT00064337-ae
event group key
EG002
event group label
Dex/Thal
serious affected
1
serious at risk
12
other affected
12
other at risk
12
frequency threshold
5
collection period
Source null
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