Rituximab and Cyclophosphamide in Treating Patients With High Risk, Refractory, or Relapsed 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

Percentage of study participants who did not report that their multiple myeloma relapsed or progressed (got worse)

Source null

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primary · NOT_POSTED

Safety of Maintenance Rituximab Following High Dose Cyclophosphamide

Source null

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secondary · NOT_POSTED

Safety and Toxicity

Source null

→

secondary · NOT_POSTED

Complete Response (CR) Rate and Partial Response (PR) Rate

Source null

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secondary · NOT_POSTED

Effect of Rituximab by Clonogenic Growth of Multiple Myeloma (MM) Progenitors and the Mechanisms by Which MM Stem Cells Are Inhibited

Source null

→

secondary · NOT_POSTED

Overall Survival

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-darzalex-faspro-f9050675
nct id: NCT00258206
trial label: Rituximab and Cyclophosphamide in Treating Patients With High Risk, Refractory, or Relapsed 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: 6
harms Count: 1
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-multiple-myeloma-darzalex-faspro-f9050675
nct id
NCT00258206
outcome key
om-0000
source section id
NCT00258206-om-0000
source outcome index
0
endpoint
Event-free Survival
endpoint definition
Percentage of study participants who did not report that their multiple myeloma relapsed or progressed (got worse)
time origin
1 year
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-multiple-myeloma-darzalex-faspro-f9050675
nct id
NCT00258206
outcome key
om-0001
source section id
NCT00258206-om-0001
source outcome index
1
endpoint
Safety of Maintenance Rituximab Following High Dose Cyclophosphamide
endpoint definition
Safety of Maintenance Rituximab Following High Dose Cyclophosphamide
time origin
2, 3, 6, 9, and 12 months
analysis role
primary
reporting status
NOT_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-multiple-myeloma-darzalex-faspro-f9050675
nct id
NCT00258206
outcome key
om-0002
source section id
NCT00258206-om-0002
source outcome index
2
endpoint
Safety and Toxicity
endpoint definition
Safety and Toxicity
time origin
2, 3, 6, 9, and 12 months
analysis role
secondary
reporting status
NOT_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-multiple-myeloma-darzalex-faspro-f9050675
nct id
NCT00258206
outcome key
om-0003
source section id
NCT00258206-om-0003
source outcome index
3
endpoint
Complete Response (CR) Rate and Partial Response (PR) Rate
endpoint definition
Complete Response (CR) Rate and Partial Response (PR) Rate
time origin
1 year
analysis role
secondary
reporting status
NOT_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-multiple-myeloma-darzalex-faspro-f9050675
nct id
NCT00258206
outcome key
om-0004
source section id
NCT00258206-om-0004
source outcome index
4
endpoint
Effect of Rituximab by Clonogenic Growth of Multiple Myeloma (MM) Progenitors and the Mechanisms by Which MM Stem Cells Are Inhibited
endpoint definition
Effect of Rituximab by Clonogenic Growth of Multiple Myeloma (MM) Progenitors and the Mechanisms by Which MM Stem Cells Are Inhibited
time origin
2, 3, 6, 9, and 12 months
analysis role
secondary
reporting status
NOT_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-multiple-myeloma-darzalex-faspro-f9050675
nct id
NCT00258206
outcome key
om-0005
source section id
NCT00258206-om-0005
source outcome index
5
endpoint
Overall Survival
endpoint definition
Overall Survival
time origin
5 years
analysis role
secondary
reporting status
NOT_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-darzalex-faspro-f9050675
nct id
NCT00258206
outcome key
om-0000
arm key
OG000
arm label
Rituximab + Cyclophosphamide
regimen
Rituximab 375 mg/m\^2 on Days -10 and -7; Cyclophosphamide 50 mg/kg on days -3, -2, -1, and 0; Rituximab 375 mg/m\^2 weekly x4 after platelet counts recover; For patients achieving at least stable disease, rituximab maintenance 375 mg/m\^2 once each during months 3, 6, 9, and 12
analyzed count
21
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00258206-om-0000#groups/OG000

harms

release id
clinical-indications-draft-1
disease state id
ds-multiple-myeloma-darzalex-faspro-f9050675
nct id
NCT00258206
harm key
EG000
source section id
NCT00258206-ae
event group key
EG000
event group label
Rituximab + Cyclophosphamide
serious affected
0
serious at risk
21
other affected
0
other at risk
21
frequency threshold
0
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