Flavopiridol in Treating Patients With Relapsed or Refractory Lymphoma or 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

Dose limiting toxicity (DLT) for an individual disease group is defined as 1) any grade 3-4 non-hematologic toxicity (except leukopenia or neutropenia) that does not resolve or decrease to grade 1-2 within 2 weeks, or 2) any grade 4 hematologic toxicity that causes more than a 1 week delay in administration of therapy.

Source null

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primary · POSTED

The maximum tolerated dose (MTD) is defined as that dose level beneath the dose at which 2 or more of 6 patients experience DLT.

Source null

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primary · POSTED

Patients were assessed for clinical response after two , four and six cycle with laboratory studies, physical exam, and CT scans. Response was evaluated using the modified NCI-sponsored Working Group Lymphoma Response Criteria.

Includes patients enrolled with Indolent B-cell NHL, Intermediate Grade B NHL, Mantle cell NHL and T/NK-cell NHL

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primary · POSTED

The NCI Common Toxicity Criteria for Adverse Events (version 3.0) were used to define and grade toxicity for patients.

Grade 3 and 4 toxicities.

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primary · POSTED

Identify subsets, based on levels of response (PR and SD), of lymphoid / plasma cell malignancies that are suitable for larger phase II studies designed to further evaluate the efficacy and toxicity of flavopiridol.

Response indicated for Indolent B-cell NHL, Mantle cell NHL and T-cell NHL

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secondary · POSTED

Whole blood samples were collected for pharmacokinetics analysis during the first (Day 1) and fourth (Day 22) treatments during cycle 1. Samples were collected on both occasions prior to dosing and at 0.5, 1, 3, 4.5, 6, 8 and 24 hour after the start of the bolus infusion.

total of 71 PK (Pharmacokinetic) profiles comprising 484 plasma concentration were determined for 45 of 46 patients following treatment

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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-sarclisa-escena-9eb42ed1
nct id: NCT00112723
trial label: Flavopiridol in Treating Patients With Relapsed or Refractory Lymphoma or 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-sarclisa-escena-9eb42ed1
nct id
NCT00112723
outcome key
om-0000
source section id
NCT00112723-om-0000
source outcome index
0
endpoint
Disease-specific Dose-limiting Toxicity and Maximum Tolerated Dose of Flavopiridol Graded According to the CTCAE (Common Toxicity Criteria for Adverse Effects) Version 4.0 (Phase I)
endpoint definition
Dose limiting toxicity (DLT) for an individual disease group is defined as 1) any grade 3-4 non-hematologic toxicity (except leukopenia or neutropenia) that does not resolve or decrease to grade 1-2 within 2 weeks, or 2) any grade 4 hematologic toxicity that causes more than a 1 week delay in administration of therapy.
time origin
28 days
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-sarclisa-escena-9eb42ed1
nct id
NCT00112723
outcome key
om-0001
source section id
NCT00112723-om-0001
source outcome index
1
endpoint
Maximum Tolerated Dose (MTD)
endpoint definition
The maximum tolerated dose (MTD) is defined as that dose level beneath the dose at which 2 or more of 6 patients experience DLT.
time origin
28 days
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-sarclisa-escena-9eb42ed1
nct id
NCT00112723
outcome key
om-0002
source section id
NCT00112723-om-0002
source outcome index
2
endpoint
Complete and Partial Response Rate (Phase II)
endpoint definition
Patients were assessed for clinical response after two , four and six cycle with laboratory studies, physical exam, and CT scans. Response was evaluated using the modified NCI-sponsored Working Group Lymphoma Response Criteria.
time origin
Up to 2 years
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Includes patients enrolled with Indolent B-cell NHL, Intermediate Grade B NHL, Mantle cell NHL and T/NK-cell NHL
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-sarclisa-escena-9eb42ed1
nct id
NCT00112723
outcome key
om-0003
source section id
NCT00112723-om-0003
source outcome index
3
endpoint
Qualitative and Quantitative Toxicities in Regard to Organ Specificity
endpoint definition
The NCI Common Toxicity Criteria for Adverse Events (version 3.0) were used to define and grade toxicity for patients.
time origin
Up to 30 days after completion of study treatment
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Grade 3 and 4 toxicities.
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-sarclisa-escena-9eb42ed1
nct id
NCT00112723
outcome key
om-0004
source section id
NCT00112723-om-0004
source outcome index
4
endpoint
Lymphoid/Plasma Cell Malignancies
endpoint definition
Identify subsets, based on levels of response (PR and SD), of lymphoid / plasma cell malignancies that are suitable for larger phase II studies designed to further evaluate the efficacy and toxicity of flavopiridol.
time origin
Up to 2 years
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Response indicated for Indolent B-cell NHL, Mantle cell NHL and T-cell NHL
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-sarclisa-escena-9eb42ed1
nct id
NCT00112723
outcome key
om-0005
source section id
NCT00112723-om-0005
source outcome index
5
endpoint
Pharmacokinetics (Area Under the Curve; AUC) of Flavopiridol
endpoint definition
Whole blood samples were collected for pharmacokinetics analysis during the first (Day 1) and fourth (Day 22) treatments during cycle 1. Samples were collected on both occasions prior to dosing and at 0.5, 1, 3, 4.5, 6, 8 and 24 hour after the start of the bolus infusion.
time origin
0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose on Days 1 and 22 of Cycle 1
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
total of 71 PK (Pharmacokinetic) profiles comprising 484 plasma concentration were determined for 45 of 46 patients following treatment
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-sarclisa-escena-9eb42ed1
nct id
NCT00112723
outcome key
om-0000
arm key
OG000
arm label
Dose Level 1 (Flavopiridol 30 mg/m2 + 30 mg/m2)
regimen
PHASE I: Patients receive flavopiridol IV over 4½ hours on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. PHASE II: Patients receive flavopiridol\* as in phase I at the MTD determined in phase I.
analyzed count
11
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00112723-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-multiple-myeloma-sarclisa-escena-9eb42ed1
nct id
NCT00112723
outcome key
om-0000
arm key
OG001
arm label
Dose Level 2 (Flavopiridol 30 mg/m2 + 50 mg/m2)
regimen
PHASE I: Patients receive flavopiridol IV over 4½ hours on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. PHASE II: Patients receive flavopiridol\* as in phase I at the MTD determined in phase I.
analyzed count
19
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00112723-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-multiple-myeloma-sarclisa-escena-9eb42ed1
nct id
NCT00112723
outcome key
om-0000
arm key
OG002
arm label
Dose Level 3 (Flavopiridol 50 mg/m2 + 50 mg/m2)
regimen
PHASE I: Patients receive flavopiridol IV over 4½ hours on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. PHASE II: Patients receive flavopiridol\* as in phase I at the MTD determined in phase I.
analyzed count
14
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00112723-om-0000#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-multiple-myeloma-sarclisa-escena-9eb42ed1
nct id
NCT00112723
outcome key
om-0001
arm key
OG000
arm label
Dose Level 1 (30+30)
regimen
PHASE I: Patients receive flavopiridol IV over 4½ hours on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. PHASE II: Patients receive flavopiridol\* as in phase I at the MTD determined in phase I. alvocidib: Given IV
analyzed count
11
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00112723-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-multiple-myeloma-sarclisa-escena-9eb42ed1
nct id
NCT00112723
outcome key
om-0001
arm key
OG001
arm label
Level 2 (30+50)
regimen
PHASE I: Patients receive flavopiridol IV over 4½ hours on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. PHASE II: Patients receive flavopiridol\* as in phase I at the MTD determined in phase I.
analyzed count
12
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00112723-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-multiple-myeloma-sarclisa-escena-9eb42ed1
nct id
NCT00112723
outcome key
om-0001
arm key
OG002
arm label
Level 3 (50+50)
regimen
PHASE I: Patients receive flavopiridol IV over 4½ hours on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. PHASE II: Patients receive flavopiridol\* as in phase I at the MTD determined in phase I.
analyzed count
12
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00112723-om-0001#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-multiple-myeloma-sarclisa-escena-9eb42ed1
nct id
NCT00112723
outcome key
om-0002
arm key
OG000
arm label
Dose Level 1 (Flavopiridol 30 mg/m2 + 30 mg/m2)
regimen
Patients receive flavopiridol IV over 4½ hours on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of flavopiridol until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
analyzed count
12
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00112723-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-multiple-myeloma-sarclisa-escena-9eb42ed1
nct id
NCT00112723
outcome key
om-0002
arm key
OG001
arm label
Dose Level 2 (Flavopiridol 30 mg/m2 + 50 mg/m2)
regimen
Patients receive flavopiridol IV over 4½ hours on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of flavopiridol until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
analyzed count
17
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00112723-om-0002#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-multiple-myeloma-sarclisa-escena-9eb42ed1
nct id
NCT00112723
outcome key
om-0002
arm key
OG002
arm label
Dose Level 3 Dose (Flavopiridol 50 mg/m2 + 50 mg/m2)
regimen
Patients receive flavopiridol IV over 4½ hours on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of flavopiridol until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
analyzed count
14
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00112723-om-0002#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-multiple-myeloma-sarclisa-escena-9eb42ed1
nct id
NCT00112723
outcome key
om-0003
arm key
OG000
arm label
Dose Levels 1, 2, 3
regimen
Dose Level 1 (30 mg/m2 + 30 mg/m2), Dose Level 2 (30 mg/m2 + 50 mg/m2), Dose Level 3 (50 mg/m2 + 50 mg/m2) PHASE I: Patients receive flavopiridol IV over 4½ hours on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. PHASE II: Patients receive flavopiridol\* as in phase I at the MTD determined in phase I. alvocidib: Given IV
analyzed count
35
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00112723-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-multiple-myeloma-sarclisa-escena-9eb42ed1
nct id
NCT00112723
outcome key
om-0004
arm key
OG000
arm label
Cohort 1
regimen
Patients diagnosed with Indolent B-cell NHL
analyzed count
13
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00112723-om-0004#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-multiple-myeloma-sarclisa-escena-9eb42ed1
nct id
NCT00112723
outcome key
om-0004
arm key
OG001
arm label
Cohort 2
regimen
Patients diagnosed with Mantle Cell NHL
analyzed count
6
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00112723-om-0004#groups/OG001

harms

release id
clinical-indications-draft-1
disease state id
ds-multiple-myeloma-sarclisa-escena-9eb42ed1
nct id
NCT00112723
harm key
EG000
source section id
NCT00112723-ae
event group key
EG000
event group label
Treatment (Alvocidib)
serious affected
0
serious at risk
35
other affected
34
other at risk
35
frequency threshold
5
collection period
Patients were assessed for clinical response after two, four and six cycles with laboratory studies, physical exam, and CT scans.
event definition
NCI Common Toxicity Criteria for Adverse Events (version 3.0) was used to define and grade toxicity.
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