Panobinostat and Everolimus in Treating Patients With Recurrent Multiple Myeloma, Non-Hodgkin Lymphoma, or Hodgkin Lymphoma

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. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. 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.

exploratory · NOT_POSTED

Changes in parameters will be both graphically and quantitatively summarized and explored. Standard paired comparisons methodologies (paired t-tests, Wilcoxon signed rank tests and Fisher's exact tests for interval, ordinal and nominal level data, respectively) will be used to assess changes in these variables before and after therapy. In addition, these changes in pharmacologic markers and biological results will be explored in relation to clinical outcome to explore any differences between responders and non-responders.

Source null

→

primary · POSTED

The Maximum Tolerated Dose (MTD) is defined as the dose level below the lowest dose that induces dose-limiting toxicity (DLT) in at least one-third of patients graded according to NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. Dose-limiting toxicities include non-hematologic events graded 3 or higher and deemed at least possibly related to treatment. A total of 6 patients treated at the MTD will be sufficient to identify common toxicities at the MTD. The number of patients reporting a dose-limiting event are reported.

The overall number of participants analyzed noted above were enrolled in and completed Phase I of the study to determine the maximum tolerated dose (MTD).

→

primary · POSTED

For myeloma, a complete response(CR, defined as Negative immunofixation(IFE) of the serum and urine, \< 5% plasma cells in bone marrow(BM), Disappearance of plasmacytomas), stringent CR(sCR, defined as CR plus Normal serum FLC ratio, Absence of clonal cells in BM), very good partial response(VGPR, defined as PR plus Serum and urine M-component detectable by IFE but not on electrophoresis), partial response(PR, defined as a ≥ 50% reduction of serum M-protein and/or reduction in 24-h urinary M-protein by ≥ 90% or to \<200 mg per 24 h), or minor response(MR, defined as ≥25% but \< 49% reduction of serum M-protein and reduction in 24h urine M-protein by 50-89%) noted as the objective status. For lymphoma, a CR(defined as no evidence of measurable disease), or PR(defined as regression of measurable disease and no new sites of disease) noted as the objective status. Percentage of successes will be estimated by 100 times the number of successes divided by the total number of evaluable patients.

Patients who were enrolled in and completed Phase II and treated at a starting dose of 20 mg or 30/40 mg LBH589 were evaluated in this analysis.

→

secondary · POSTED

Overall survival time is defined as the time from registration to death due to any cause. The median and 95% confidence intervals will be estimated using the method of Kaplan-Meier.

Patients who were enrolled in and completed Phase II and treated at a starting dose of 20 mg or 30/40 mg LBH589 were evaluated in this analysis.

→

secondary · POSTED

Progression-free survival time is defined as the time from registration to progression or death due to any cause. Progression is defined for myeloma as Any one or more of the following: Increase of 25% from lowest value in, Serum M-component (absolute increase must be ≥ 0.5 g/dl), Serum M-component increase ≥ 1 g/dl, if lowest M component was ≥ 5 g/dl,Urine M-component (absolute increase must be ≥ 200 mg/24 h), Bone marrow plasma cell percentage (absolute % must be ≥10%) Or any one or more of the following felt related to the underlying clonal plasma cell proliferative disorder: Development of new soft tissue plasmacytomas or bone lesions, Hypercalcemia (≥11.5 mg/dl) Decrease in hemoglobin of ≥2 g/dl, Serum creatinine level ≥2 mg/dl. Progression is defined for lymphoma as any new lesion or increase by ≥50% of previously involved sites from nadir. The median and 95% confidence intervals are estimated using the method of Kaplan-Meier.

Patients who were enrolled in and completed Phase II and treated at a starting dose of 20 mg or 30/40 mg LBH589 were evaluated in this analysis.

→

secondary · POSTED

Duration of response is defined as the time from the date at which the objective status is first noted to be (for myeloma) a complete response (CR, defined as Negative immunofixation(IFE) of the serum and urine, \< 5% plasma cells in bone marrow(BM), Disappearance of plasmacytomas), stringent CR(sCR, defined as CR plus Normal serum FLC ratio, Absence of clonal cells in BM), very good partial response(VGPR, defined as PR plus Serum and urine M-component detectable by IFE but not on electrophoresis), partial response(PR, defined as a ≥ 50% reduction of serum M-protein and/or reduction in 24-h urinary M-protein by ≥ 90% or to \<200 mg per 24 h) or minor response(MR, defined as ≥25% but \< 49% reduction of serum M-protein and reduction in 24h urine M-protein by 50-89%); (for lymphoma) a CR(defined as no evidence of measurable disease), or PR(defined as regression of measurable disease and no new sites of disease) noted as the objective status. Estimated using the method of Kaplan-Meier.

Patients who were enrolled in and completed Phase II and objective status are first noted to be CR, sCR, VGPR, PR or MR were evaluable for this endpoint.

→

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-primary-central-nervous-system-lymphoma
nct id: NCT00918333
trial label: Panobinostat and Everolimus in Treating Patients With Recurrent Multiple Myeloma, Non-Hodgkin Lymphoma, or Hodgkin Lymphoma
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. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
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: 2
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-primary-central-nervous-system-lymphoma
nct id
NCT00918333
outcome key
om-0005
source section id
NCT00918333-om-0005
source outcome index
5
endpoint
Change in Pharmacologic (Pharmacokinetic/Pharmacodynamic) Parameters
endpoint definition
Changes in parameters will be both graphically and quantitatively summarized and explored. Standard paired comparisons methodologies (paired t-tests, Wilcoxon signed rank tests and Fisher's exact tests for interval, ordinal and nominal level data, respectively) will be used to assess changes in these variables before and after therapy. In addition, these changes in pharmacologic markers and biological results will be explored in relation to clinical outcome to explore any differences between responders and non-responders.
time origin
Day 5 and 19 of the first course and then day 1 of each subsequent courses (courses 2-4) prior to the daily dose and 1 and 2 hours after each dose
analysis role
exploratory
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-primary-central-nervous-system-lymphoma
nct id
NCT00918333
outcome key
om-0000
source section id
NCT00918333-om-0000
source outcome index
0
endpoint
Number of Phase I Participants With Dose-Limiting Toxicity Events (Phase I)
endpoint definition
The Maximum Tolerated Dose (MTD) is defined as the dose level below the lowest dose that induces dose-limiting toxicity (DLT) in at least one-third of patients graded according to NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. Dose-limiting toxicities include non-hematologic events graded 3 or higher and deemed at least possibly related to treatment. A total of 6 patients treated at the MTD will be sufficient to identify common toxicities at the MTD. The number of patients reporting a dose-limiting event are reported.
time origin
4 weeks
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
The overall number of participants analyzed noted above were enrolled in and completed Phase I of the study to determine the maximum tolerated dose (MTD).
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-primary-central-nervous-system-lymphoma
nct id
NCT00918333
outcome key
om-0001
source section id
NCT00918333-om-0001
source outcome index
1
endpoint
Overall Response Rate (Phase II)
endpoint definition
For myeloma, a complete response(CR, defined as Negative immunofixation(IFE) of the serum and urine, \< 5% plasma cells in bone marrow(BM), Disappearance of plasmacytomas), stringent CR(sCR, defined as CR plus Normal serum FLC ratio, Absence of clonal cells in BM), very good partial response(VGPR, defined as PR plus Serum and urine M-component detectable by IFE but not on electrophoresis), partial response(PR, defined as a ≥ 50% reduction of serum M-protein and/or reduction in 24-h urinary M-protein by ≥ 90% or to \<200 mg per 24 h), or minor response(MR, defined as ≥25% but \< 49% reduction of serum M-protein and reduction in 24h urine M-protein by 50-89%) noted as the objective status. For lymphoma, a CR(defined as no evidence of measurable disease), or PR(defined as regression of measurable disease and no new sites of disease) noted as the objective status. Percentage of successes will be estimated by 100 times the number of successes divided by the total number of evaluable patients.
time origin
Up to 12 courses
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Patients who were enrolled in and completed Phase II and treated at a starting dose of 20 mg or 30/40 mg LBH589 were evaluated in this analysis.
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-primary-central-nervous-system-lymphoma
nct id
NCT00918333
outcome key
om-0002
source section id
NCT00918333-om-0002
source outcome index
2
endpoint
Overall Survival Time (Phase II)
endpoint definition
Overall survival time is defined as the time from registration to death due to any cause. The median and 95% confidence intervals will be estimated using the method of Kaplan-Meier.
time origin
Time from registration to death due to any cause, assessed up to 2 years post-treatment
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Patients who were enrolled in and completed Phase II and treated at a starting dose of 20 mg or 30/40 mg LBH589 were evaluated in this analysis.
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-primary-central-nervous-system-lymphoma
nct id
NCT00918333
outcome key
om-0003
source section id
NCT00918333-om-0003
source outcome index
3
endpoint
Progression-free Survival (Phase II)
endpoint definition
Progression-free survival time is defined as the time from registration to progression or death due to any cause. Progression is defined for myeloma as Any one or more of the following: Increase of 25% from lowest value in, Serum M-component (absolute increase must be ≥ 0.5 g/dl), Serum M-component increase ≥ 1 g/dl, if lowest M component was ≥ 5 g/dl,Urine M-component (absolute increase must be ≥ 200 mg/24 h), Bone marrow plasma cell percentage (absolute % must be ≥10%) Or any one or more of the following felt related to the underlying clonal plasma cell proliferative disorder: Development of new soft tissue plasmacytomas or bone lesions, Hypercalcemia (≥11.5 mg/dl) Decrease in hemoglobin of ≥2 g/dl, Serum creatinine level ≥2 mg/dl. Progression is defined for lymphoma as any new lesion or increase by ≥50% of previously involved sites from nadir. The median and 95% confidence intervals are estimated using the method of Kaplan-Meier.
time origin
Time from registration to progression or death due to any cause, assessed up to 2 years post-treatment
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Patients who were enrolled in and completed Phase II and treated at a starting dose of 20 mg or 30/40 mg LBH589 were evaluated in this analysis.
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-primary-central-nervous-system-lymphoma
nct id
NCT00918333
outcome key
om-0004
source section id
NCT00918333-om-0004
source outcome index
4
endpoint
Duration of Response (Phase II)
endpoint definition
Duration of response is defined as the time from the date at which the objective status is first noted to be (for myeloma) a complete response (CR, defined as Negative immunofixation(IFE) of the serum and urine, \< 5% plasma cells in bone marrow(BM), Disappearance of plasmacytomas), stringent CR(sCR, defined as CR plus Normal serum FLC ratio, Absence of clonal cells in BM), very good partial response(VGPR, defined as PR plus Serum and urine M-component detectable by IFE but not on electrophoresis), partial response(PR, defined as a ≥ 50% reduction of serum M-protein and/or reduction in 24-h urinary M-protein by ≥ 90% or to \<200 mg per 24 h) or minor response(MR, defined as ≥25% but \< 49% reduction of serum M-protein and reduction in 24h urine M-protein by 50-89%); (for lymphoma) a CR(defined as no evidence of measurable disease), or PR(defined as regression of measurable disease and no new sites of disease) noted as the objective status. Estimated using the method of Kaplan-Meier.
time origin
The time from the date at which the patient's objective status is first noted to be a CR, sCR, VGPR, PR, or minor response to the earliest date progression is documented, assessed up to 2 years post-treatment
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Patients who were enrolled in and completed Phase II and objective status are first noted to be CR, sCR, VGPR, PR or MR were evaluable for this endpoint.
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-primary-central-nervous-system-lymphoma
nct id
NCT00918333
outcome key
om-0000
arm key
OG000
arm label
Phase I (Panobinostat + Everolimus)
regimen
Patients receive 10, 15, 20, 30 or 40 mg/day panobinostat PO 3 times/week or on days 1, 3, 5, 15, 17, and 19 and 5 or 10 mg/day everolimus PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
analyzed count
23
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00918333-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-primary-central-nervous-system-lymphoma
nct id
NCT00918333
outcome key
om-0001
arm key
OG000
arm label
Phase II (Lymphoma Patients Receiving 20 mg LBL589)
regimen
Lymphoma patients receive 20 mg/day panobinostat (LBH589) PO on days 1, 3, 5, 15, 17, and 19 and 5 mg/day everolimus PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
analyzed count
41
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00918333-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-primary-central-nervous-system-lymphoma
nct id
NCT00918333
outcome key
om-0001
arm key
OG001
arm label
Phase II (Myeloma Patients Receiving 20 mg LBH589)
regimen
Myeloma patients receive 20 mg/day panobinostat (LBH589) PO on days 1, 3, 5, 15, 17, and 19 and 5 mg/day everolimus PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
analyzed count
14
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00918333-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-primary-central-nervous-system-lymphoma
nct id
NCT00918333
outcome key
om-0001
arm key
OG002
arm label
Phase II (Lymphoma Patients Receiving 30/40 mg LBH589)
regimen
Lymphoma patients receive 30 or 40 mg/day panobinostat (LBH589) PO on days 1, 3, 5, 15, 17, and 19 and 5 mg/day everolimus PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
analyzed count
20
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00918333-om-0001#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-primary-central-nervous-system-lymphoma
nct id
NCT00918333
outcome key
om-0001
arm key
OG003
arm label
Phase II (Myeloma Patients Receiving 30/40 mg LBH589)
regimen
Myeloma patients receive 30 or 40 mg/day panobinostat (LBH589) PO on days 1, 3, 5, 15, 17, and 19 and 5 mg/day everolimus PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
analyzed count
18
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00918333-om-0001#groups/OG003
release id
clinical-indications-draft-1
disease state id
ds-primary-central-nervous-system-lymphoma
nct id
NCT00918333
outcome key
om-0002
arm key
OG000
arm label
Phase II (Lymphoma Patients Receiving 20 mg LBL589)
regimen
Lymphoma patients receive 20 mg/day panobinostat (LBH589) PO on days 1, 3, 5, 15, 17, and 19 and 5 mg/day everolimus PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
analyzed count
41
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00918333-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-primary-central-nervous-system-lymphoma
nct id
NCT00918333
outcome key
om-0002
arm key
OG001
arm label
Phase II (Myeloma Patients Receiving 20 mg LBH589)
regimen
Myeloma patients receive 20 mg/day panobinostat (LBH589) PO on days 1, 3, 5, 15, 17, and 19 and 5 mg/day everolimus PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
analyzed count
14
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00918333-om-0002#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-primary-central-nervous-system-lymphoma
nct id
NCT00918333
outcome key
om-0002
arm key
OG002
arm label
Phase II (Lymphoma Patients Receiving 30/40 mg LBH589)
regimen
Lymphoma patients receive 30 or 40 mg/day panobinostat (LBH589) PO on days 1, 3, 5, 15, 17, and 19 and 5 mg/day everolimus PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
analyzed count
20
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00918333-om-0002#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-primary-central-nervous-system-lymphoma
nct id
NCT00918333
outcome key
om-0002
arm key
OG003
arm label
Phase II (Myeloma Patients Receiving 30/40 mg LBH589)
regimen
Myeloma patients receive 30 or 40 mg/day panobinostat (LBH589) PO on days 1, 3, 5, 15, 17, and 19 and 5 mg/day everolimus PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
analyzed count
18
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00918333-om-0002#groups/OG003
release id
clinical-indications-draft-1
disease state id
ds-primary-central-nervous-system-lymphoma
nct id
NCT00918333
outcome key
om-0003
arm key
OG000
arm label
Phase II (Lymphoma Patients Receiving 20 mg LBL589)
regimen
Lymphoma patients receive 20 mg/day panobinostat (LBH589) PO on days 1, 3, 5, 15, 17, and 19 and 5 mg/day everolimus PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
analyzed count
41
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00918333-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-primary-central-nervous-system-lymphoma
nct id
NCT00918333
outcome key
om-0003
arm key
OG001
arm label
Phase II (Myeloma Patients Receiving 20 mg LBH589)
regimen
Myeloma patients receive 20 mg/day panobinostat (LBH589) PO on days 1, 3, 5, 15, 17, and 19 and 5 mg/day everolimus PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
analyzed count
14
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00918333-om-0003#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-primary-central-nervous-system-lymphoma
nct id
NCT00918333
outcome key
om-0003
arm key
OG002
arm label
Phase II (Lymphoma Patients Receiving 30/40 mg LBH589)
regimen
Lymphoma patients receive 30 or 40 mg/day panobinostat (LBH589) PO on days 1, 3, 5, 15, 17, and 19 and 5 mg/day everolimus PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
analyzed count
20
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00918333-om-0003#groups/OG002

harms

release id
clinical-indications-draft-1
disease state id
ds-primary-central-nervous-system-lymphoma
nct id
NCT00918333
harm key
EG000
source section id
NCT00918333-ae
event group key
EG000
event group label
Phase I (Panobinostat + Everolimus)
serious affected
3
serious at risk
23
other affected
23
other at risk
23
frequency threshold
0
collection period
Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
event definition
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
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-primary-central-nervous-system-lymphoma
nct id
NCT00918333
harm key
EG001
source section id
NCT00918333-ae
event group key
EG001
event group label
Phase II (Panobinostat + Everolimus)
serious affected
25
serious at risk
93
other affected
92
other at risk
93
frequency threshold
0
collection period
Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
event definition
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
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