Trial · NCT00918333
Panobinostat and Everolimus in Treating Patients With Recurrent Multiple Myeloma, Non-Hodgkin Lymphoma, or Hodgkin Lymphoma
NCT00918333, Phase 1, Phase 2, Completed, Mayo Clinic; results first posted 2018-05-18
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Panobinostat and Everolimus in Treating Patients With Recurrent Multiple Myeloma, Non-Hodgkin Lymphoma, or Hodgkin Lymphoma. Trials, record NCT00918333. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00918333
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Panobinostat and Everolimus in Treating Patients With Recurrent Multiple Myeloma, Non-Hodgkin Lymphoma, or Hodgkin Lymphoma
- NCT number
- NCT00918333
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 124 participants, actual
- Lead sponsor
- Mayo Clinic
- Conditions
Adult Nasal Type Extranodal NK/T-cell Lymphoma, Anaplastic Large Cell Lymphoma, Angioimmunoblastic T-cell Lymphoma, B-cell Adult Acute Lymphoblastic Leukemia, Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue, Hepatosplenic T-cell Lymphoma, Nodal Marginal Zone B-cell Lymphoma, Post-transplant Lymphoproliferative Disorder, Primary Central Nervous System Non-Hodgkin Lymphoma, Recurrent Adult Acute Lymphoblastic Leukemia, Recurrent Adult Burkitt Lymphoma, Recurrent Adult Diffuse Large Cell Lymphoma, Recurrent Adult Hodgkin Lymphoma, Recurrent Adult Lymphoblastic Lymphoma, Recurrent Adult T-cell Leukemia/Lymphoma, Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma, Recurrent Grade 1 Follicular Lymphoma, Recurrent Grade 2 Follicular Lymphoma, Recurrent Grade 3 Follicular Lymphoma, Recurrent Mantle Cell Lymphoma, Recurrent Marginal Zone Lymphoma, Recurrent Mycosis Fungoides/Sezary Syndrome, Recurrent Small Lymphocytic Lymphoma, Refractory Chronic Lymphocytic Leukemia, Refractory Multiple Myeloma, Splenic Marginal Zone Lymphoma, T-cell Adult Acute Lymphoblastic Leukemia, Waldenström Macroglobulinemia
- Interventions
- panobinostat, everolimus, laboratory biomarker analysis, pharmacological study
- First posted
- 2009-06-11
- Last updated
- 2020-03-10
- Results first posted
- 2018-05-18
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Phase I Participants With Dose-Limiting Toxicity Events (Phase I) | 4 weeks | 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. |
| Primary | Overall Response Rate (Phase II) | Up to 12 courses | 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. |
| Secondary | Overall Survival Time (Phase II) | Time from registration to death due to any cause, assessed up to 2 years post-treatment | 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. |
| Secondary | Progression-free Survival (Phase II) | Time from registration to progression or death due to any cause, assessed up to 2 years post-treatment | 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. |
| Secondary | Duration of Response (Phase II) | 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 | 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. |
| Other | Change in Pharmacologic (Pharmacokinetic/Pharmacodynamic) Parameters | 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 | 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. |
| Other | Changes in Biological Markers | Baseline to up to 12 courses | 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 ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Phase I Participants With Dose-Limiting Toxicity Events (Phase I) | 4 weeks | 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). | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Overall Response Rate (Phase II) | Up to 12 courses | 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. | percentage of patients | NUMBER |
| SECONDARY | Overall Survival Time (Phase II) | Time from registration to death due to any cause, assessed up to 2 years post-treatment | 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. | months | MEDIAN |
| SECONDARY | Progression-free Survival (Phase II) | Time from registration to progression or death due to any cause, assessed up to 2 years post-treatment | 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. | months | MEDIAN |
| SECONDARY | Duration of Response (Phase II) | 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 | 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. | months | MEDIAN |
| OTHER_PRE_SPECIFIED | Change in Pharmacologic (Pharmacokinetic/Pharmacodynamic) Parameters | 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 | |||
| OTHER_PRE_SPECIFIED | Changes in Biological Markers | Baseline to up to 12 courses |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Phase I Participants With Dose-Limiting Toxicity Events (Phase I) | Phase I (Panobinostat + Everolimus) | 0 | Participants | ||
| Overall Response Rate (Phase II) | Phase II (Lymphoma Patients Receiving 20 mg LBL589) | 39 | 95% Confidence Interval 23 to 53 | percentage of patients | |
| Overall Response Rate (Phase II) | Phase II (Myeloma Patients Receiving 20 mg LBH589) | 7 | 95% Confidence Interval 0 to 34 | percentage of patients | |
| Overall Response Rate (Phase II) | Phase II (Lymphoma Patients Receiving 30/40 mg LBH589) | 20 | 95% Confidence Interval 2 to 31 | percentage of patients | |
| Overall Response Rate (Phase II) | Phase II (Myeloma Patients Receiving 30/40 mg LBH589) | 0 | 95% Confidence Interval 0 to 19 | percentage of patients | |
| Overall Survival Time (Phase II) | Phase II (Lymphoma Patients Receiving 20 mg LBL589) | 17.1 | 95% Confidence Interval 7.0 to NA | months | |
| Overall Survival Time (Phase II) | Phase II (Myeloma Patients Receiving 20 mg LBH589) | 16.6 | 95% Confidence Interval 9.7 to NA | months | |
| Overall Survival Time (Phase II) | Phase II (Lymphoma Patients Receiving 30/40 mg LBH589) | 35.4 | 95% Confidence Interval 11.5 to NA | months | |
| Overall Survival Time (Phase II) | Phase II (Myeloma Patients Receiving 30/40 mg LBH589) | 21.7 | 95% Confidence Interval 12.1 to 47.6 | months | |
| Progression-free Survival (Phase II) | Phase II (Lymphoma Patients Receiving 20 mg LBL589) | 3.7 | 95% Confidence Interval 2.1 to 8.3 | months |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Phase I (Panobinostat + Everolimus) | 26 | |
| Overall Study | STARTED | Phase II (Panobinostat + Everolimus) | 98 | |
| Overall Study | COMPLETED | Phase I (Panobinostat + Everolimus) | 23 | |
| Overall Study | COMPLETED | Phase II (Panobinostat + Everolimus) | 93 | |
| Overall Study | NOT COMPLETED | Phase I (Panobinostat + Everolimus) | 3 | |
| Overall Study | NOT COMPLETED | Phase II (Panobinostat + Everolimus) | 5 |
Source ClinicalTrials.gov
Adverse events262
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Blood disorder | Blood and lymphatic system disorders | Phase I (Panobinostat + Everolimus) | 0 | 23 | 0 |
| other | Blood disorder | Blood and lymphatic system disorders | Phase II (Panobinostat + Everolimus) | 1 | 93 | 1 |
| other | Hemoglobin decreased | Blood and lymphatic system disorders | Phase I (Panobinostat + Everolimus) | 22 | 23 | 167 |
| other | Hemoglobin decreased | Blood and lymphatic system disorders | Phase II (Panobinostat + Everolimus) | 91 | 93 | 349 |
| other | Palpitations | Cardiac disorders | Phase I (Panobinostat + Everolimus) | 0 | 23 | 0 |
| other | Palpitations | Cardiac disorders | Phase II (Panobinostat + Everolimus) | 1 | 93 | 1 |
| other | Sinus tachycardia | Cardiac disorders | Phase I (Panobinostat + Everolimus) | 0 | 23 | 0 |
| other | Sinus tachycardia | Cardiac disorders | Phase II (Panobinostat + Everolimus) | 1 | 93 | 1 |
| other | Keratitis | Eye disorders | Phase I (Panobinostat + Everolimus) | 0 | 23 | 0 |
| other | Keratitis | Eye disorders | Phase II (Panobinostat + Everolimus) | 1 | 93 | 1 |
1 to 10 of 262Source ClinicalTrials.gov
See all 262 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Phase I (Panobinostat + Everolimus) | 0 | 23 |
| Total, all-cause mortality | Phase II (Panobinostat + Everolimus) | 1 | 93 |
| Total, other adverse events | Phase I (Panobinostat + Everolimus) | 23 | 23 |
| Total, other adverse events | Phase II (Panobinostat + Everolimus) | 92 | 93 |
| Total, serious adverse events | Phase I (Panobinostat + Everolimus) | 3 | 23 |
| Total, serious adverse events | Phase II (Panobinostat + Everolimus) | 25 | 93 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| P30CA015083 | Mayo Clinic Comprehensive Cancer Center Support Grant | WILLMAN, CHERYL LYNN | MAYO CLINIC ROCHESTER | NATIONAL CANCER INSTITUTE | 1985 to 2025 |
Source NIH RePORTER
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Phase I (Panobinostat + Everolimus) vs Phase II (Panobinostat + Everolimus): deaths from any cause | Trial comparisons |
| Phase I (Panobinostat + Everolimus) vs Phase II (Panobinostat + Everolimus): serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00918333
GET https://conductscience.org/api/trials/v1/NCT00918333/events?page=2