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The purpose of this study was to evaluate the efficacy and safety of panobinostat in combination with bortezomib and dexamethasone in Japanese patients with relapsed/refractory multiple myeloma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LBH589 + bortezomib + dexamethasone | Experimental | Participants were administered LBH589 (panobinostat)in combination with bortezomib and dexamethasone 2 weeks on/1 week off. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LBH589 (panobinostat) | Drug | Panobinostat (PAN) capsules were supplied at dose strengths of 10 mg and 15 mg. and dosed at 20mg during treatment phase 1 (21 days) and treatment phase 2 (42 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Near Complete Response (nCR)/ Complete Response (CR) Rate | nCR plus CR rate after 8 cycles of therapy as defined by the modified European Society for Bone and Marrow Transplantation (EBMT) criteria per investigator assessment as the proportion of participants with nCR or CR as their best overall response. | after 24 weeks (8 cycles; cycle = 21 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) | PFS is defined as time from first dose of study treatment to progression or death due to any cause, based on modified European Society for Bone and Marrow Transplantation (EBMT) criteria per Investigator's assessment | duration of study up to approx. 4 years |
| Overall Response Rate (ORR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Nagoya | Aichi-ken | 467-8602 | Japan | ||
| Novartis Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33279887 | Derived | Suzuki K, Sunami K, Matsumoto M, Maki A, Shimada F, Suzuki K, Shimizu K. Phase II, Multicenter, Single-Arm, Open-Label Study to Evaluate the Efficacy and Safety of Panobinostat in Combination with Bortezomib and Dexamethasone in Japanese Patients with Relapsed or Relapsed-and-Refractory Multiple Myeloma. Acta Haematol. 2021;144(3):264-274. doi: 10.1159/000508529. Epub 2020 Dec 4. |
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Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
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Approximately 33 eligible subjects were planned to be enrolled. 31 eligible subjects were enrolled and treated with PAN+BTZ+Dex (Treatment phase 1), of which 17 subjects entered Treatment phase 2. All 31 subjects entered the post-treatment evaluation phase, of which 22 discontinued the study. 24 subjects entered the survival follow-up phase.
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| ID | Title | Description |
|---|---|---|
| FG000 | LBH589 + Bortezomib + Dexamethasone | Participants were administered LBH589 (panobinostat)in combination with bortezomib and dexamethasone 2 weeks on/1 week off. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 19, 2018 | Oct 4, 2019 |
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| bortezomib | Drug | Bortezomib (BTZ) s.c: 1.3 mg/m2 was administered during both treatment phase 1 (21 days) & treatment phase 2 (42 days). |
|
| dexamethasone | Drug | Dexamethasone (Dex): 20mg tablets taken during both treatment phase 1 (21 days & treatment phase 2 (42 days) |
|
ORR is defined as the proportion of participants with CR, nCR or partial response (PR) based on modified EBMT criteria per investigator assessment |
| 24 weeks (8 cycles; cycle = 21 days) |
| Overall Survival (OS) | OS is defined as time from first dose of study treatment to death | up to 30 days after end of study, approx. 4 years |
| Minimal Response Rate (MRR) Per Investigator | MRR is based on modified EBMT criteria per investigator assessment | after 24 weeks (8 cycles; cycle = 21 days) |
| Time to Response (TTR) Per Investigator | TTR is defined as the time from the date of first dose of study treatment to first documented response (PR or nCR or CR) per modified EBMT criteria as assessed by investigator | duration of study up to approx. 4 years |
| Time to Progression/Relapse (TTP) Per Investigator | TTP is defined as the time from the date of the first dose of study treatment to the date of the first documented disease progression or relapse | duration of study up to approx. 4 years |
| Duration of Response (DOR) Per Investigator | DOR is defined as the time from date of the first documented CR/nCR or PR to the date of the first documented progression or relapse or death due to MM | duration of study up to approx. 4 years |
| Quality of Life (QoL) as Measured by FACT/GOG-Ntx Total Score | QoL as measured by Functional Assessment of Cancer Therapy/ Gynecology Oncology Group Neurotoxicity (FACT/GOG-NTX) scale calculated scores and changes from baseline were summarized by visit. The FACT/GOG-Ntx is a measure to assess neurotoxicity from systemic chemotherapy. The recall period for this measure is the past 7 days. FACT/GOG-Ntx Total Score: 0 - 152 (28 + 28 + 24 + 28 + 44 = 152). (FACT-G Physical Well-Being Score: 0 - 28, FACT-G Social/Family Well-Being Score: 0 - 28, FACT-G Emotional Well-Being Score: 0 - 24, FACT-G Functional Well-Being Score: 0 - 28, FACT/GOG-Ntx Neurotoxicity Subscale Score: 0 - 44). 4. The scales are combined. The higher the score, the better the QOL. | Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, and 156 |
| Composite PharmacoKinetics (PK) of Panobinostat and Bortezomib: AUClast, AUC0-24h, AUC0-48h, AUCinf | PK sample collection was performed in subjects who agreed to blood samplings for the PK assessments of PAN and BTZ. The order of administration of the 3 study treatment components was 1) PAN, 2) Dex, and 3) BTZ. | Predose, 0.5h, 1h, 2h, 3h, 4h 8h, 24h, 48h post dose |
| Composite PharmacoKinetics (PK) of Panobinostat and Bortezomib: Cmax | Cmax: The maximum (peak) observed plasma concentration. PK sample collection was performed in subjects who agreed to blood samplings for the PK assessments of PAN and BTZ. The order of administration of the 3 study treatment components was 1) PAN, 2) Dex, and 3) BTZ. | Predose, 0.5h, 1h, 2h, 3h, 4h 8h, 24h, 48h post dose |
| Composite PharmacoKinetics (PK) of Panobinostat and Bortezomib: Tmax | Tmax: The time to reach maximum (peak) plasma concentration. PK sample collection was performed in subjects who agreed to blood samplings for the PK assessments of PAN and BTZ. The order of administration of the 3 study treatment components was 1) PAN, 2) Dex, and 3) BTZ. | Predose, 0.5h, 1h, 2h, 3h, 4h 8h, 24h, 48h post dose |
| Composite PharmacoKinetics (PK) of Panobinostat and Bortezomib: T1/2 | T1/2: The elimination half-life associated with the terminal slope (Lambda_z) of a semi logarithmic concentration-time curve | Predose, 0.5h, 1h, 2h, 3h, 4h 8h, 24h 48h post dose |
| Composite PharmacoKinetics (PK) of Panobinostat and Bortezomib: Lambda_z | Lambda_z: The terminal elimination rate constant (h-1) | Predose, 0.5h, 1h, 2h, 3h, 4h 8h, 24h 48h post dose |
| Composite PharmacoKinetics (PK) of Panobinostat and Bortezomib: CL/F | CL/F: The apparent total body clearance of drug from the plasma | Predose, 0.5h, 1h, 2h, 3h, 4h 8h, 24h 48h post dose |
| Composite PharmacoKinetics (PK) of Panobinostat and Bortezomib: Vz/F | Vz/F: The apparent volume of distribution during terminal phase (associated with Lambda_z) | Predose, 0.5h, 1h, 2h, 3h, 4h 8h, 24h 48h post dose |
| Kashiwa |
| Chiba |
| 277-8567 |
| Japan |
| Novartis Investigative Site | Matsuyama | Ehime | 790-8524 | Japan |
| Novartis Investigative Site | Fukuoka | Fukuoka | 812-8582 | Japan |
| Novartis Investigative Site | Ōgaki | Gifu | 503-8502 | Japan |
| Novartis Investigative Site | Maebashi | Gunma | 371 8511 | Japan |
| Novartis Investigative Site | Shibukawa | Gunma | 377-0280 | Japan |
| Novartis Investigative Site | Kobe | Hyōgo | 650-0047 | Japan |
| Novartis Investigative Site | Higashiibaraki-gun | Ibaraki | 311-3193 | Japan |
| Novartis Investigative Site | Kyoto | Kyoto | 602-8566 | Japan |
| Novartis Investigative Site | Sendai | Miyagi | 983 8520 | Japan |
| Novartis Investigative Site | Okayama | Okayama-ken | 701-1192 | Japan |
| Novartis Investigative Site | Suita | Osaka | 565 0871 | Japan |
| Novartis Investigative Site | Koto Ku | Tokyo | 135 8550 | Japan |
| Novartis Investigative Site | Shibuya City | Tokyo | 150-8935 | Japan |
| Novartis Investigative Site | Shinjuku Ku | Tokyo | 162 8655 | Japan |
| Novartis Investigative Site | Tachikawa | Tokyo | 190-0014 | Japan |
| Novartis Investigative Site | Aomori | 030 8553 | Japan |
| Novartis Investigative Site | Niigata | 951-8566 | Japan |
| Novartis Investigative Site | Tokushima | 770-8503 | Japan |
| Subjects. Discont. Prematurely |
|
| Subjects Completed Study Per Protocol |
|
| Subjs. Ntered Post-treatment Eval. Phase |
|
| Subjects Entered Survival f/u Phase |
|
| Entered Treatment Phase 2 |
|
| COMPLETED |
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| NOT COMPLETED |
|
|
The Full analysis set (FAS) comprised of all subjects who took at least one dose of any study treatment component.
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| ID | Title | Description |
|---|---|---|
| BG000 | LBH589 + Bortezomib + Dexamethasone | Participants were administered LBH589 (panobinostat)in combination with bortezomib and dexamethasone 2 weeks on/1 week off. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race/Ethnicity, Customized | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Near Complete Response (nCR)/ Complete Response (CR) Rate | nCR plus CR rate after 8 cycles of therapy as defined by the modified European Society for Bone and Marrow Transplantation (EBMT) criteria per investigator assessment as the proportion of participants with nCR or CR as their best overall response. | Full Analysis Set (FAS): The Full analysis set (FAS) comprised of all subjects who took at least one dose of any study treatment component. | Posted | Number | 90% Confidence Interval | Percentage of participants | after 24 weeks (8 cycles; cycle = 21 days) |
|
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| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Progression Free Survival (PFS) | PFS is defined as time from first dose of study treatment to progression or death due to any cause, based on modified European Society for Bone and Marrow Transplantation (EBMT) criteria per Investigator's assessment | FAS: The FAS comprised of all subjects who took at least one dose of any study treatment component. | Posted | Median | 95% Confidence Interval | months | duration of study up to approx. 4 years |
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| Secondary | Overall Response Rate (ORR) | ORR is defined as the proportion of participants with CR, nCR or partial response (PR) based on modified EBMT criteria per investigator assessment | FAS: The FAS comprised of all subjects who took at least one dose of any study treatment component. | Posted | Number | 95% Confidence Interval | Percentage of participants | 24 weeks (8 cycles; cycle = 21 days) |
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| Secondary | Overall Survival (OS) | OS is defined as time from first dose of study treatment to death | FAS: The FAS comprised of all subjects who took at least one dose of any study treatment component. | Posted | Median | 95% Confidence Interval | months | up to 30 days after end of study, approx. 4 years |
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| Secondary | Minimal Response Rate (MRR) Per Investigator | MRR is based on modified EBMT criteria per investigator assessment | FAS: The FAS comprised of all subjects who took at least one dose of any study treatment component. | Posted | Number | Percentage of participants | after 24 weeks (8 cycles; cycle = 21 days) |
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| Secondary | Time to Response (TTR) Per Investigator | TTR is defined as the time from the date of first dose of study treatment to first documented response (PR or nCR or CR) per modified EBMT criteria as assessed by investigator | FAS: The FAS comprised of all subjects who took at least one dose of any study treatment component. | Posted | Median | 95% Confidence Interval | months | duration of study up to approx. 4 years |
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| Secondary | Time to Progression/Relapse (TTP) Per Investigator | TTP is defined as the time from the date of the first dose of study treatment to the date of the first documented disease progression or relapse | FAS: The FAS comprised of all subjects who took at least one dose of any study treatment component. | Posted | Median | 95% Confidence Interval | months | duration of study up to approx. 4 years |
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| Secondary | Duration of Response (DOR) Per Investigator | DOR is defined as the time from date of the first documented CR/nCR or PR to the date of the first documented progression or relapse or death due to MM | FAS: The FAS comprised of all subjects who took at least one dose of any study treatment component. | Posted | Median | 95% Confidence Interval | months | duration of study up to approx. 4 years |
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| Secondary | Quality of Life (QoL) as Measured by FACT/GOG-Ntx Total Score | QoL as measured by Functional Assessment of Cancer Therapy/ Gynecology Oncology Group Neurotoxicity (FACT/GOG-NTX) scale calculated scores and changes from baseline were summarized by visit. The FACT/GOG-Ntx is a measure to assess neurotoxicity from systemic chemotherapy. The recall period for this measure is the past 7 days. FACT/GOG-Ntx Total Score: 0 - 152 (28 + 28 + 24 + 28 + 44 = 152). (FACT-G Physical Well-Being Score: 0 - 28, FACT-G Social/Family Well-Being Score: 0 - 28, FACT-G Emotional Well-Being Score: 0 - 24, FACT-G Functional Well-Being Score: 0 - 28, FACT/GOG-Ntx Neurotoxicity Subscale Score: 0 - 44). 4. The scales are combined. The higher the score, the better the QOL. | FAS: The FAS comprised of all subjects who took at least one dose of any study treatment component. | Posted | Median | Full Range | scores on a scale | Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, and 156 |
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| Secondary | Composite PharmacoKinetics (PK) of Panobinostat and Bortezomib: AUClast, AUC0-24h, AUC0-48h, AUCinf | PK sample collection was performed in subjects who agreed to blood samplings for the PK assessments of PAN and BTZ. The order of administration of the 3 study treatment components was 1) PAN, 2) Dex, and 3) BTZ. | PAS: Pharmacokinetic Analysis Set (PAS): The PK analysis set for PAN (PAS-PAN) consisted of all subjects with at least one evaluable PK concentration of PAN. The PK analysis set for BTZ (PAS-BTZ) consisted of all subjects with at least one evaluable PK concentration of BTZ. | Posted | Geometric Mean | Geometric Coefficient of Variation | h.ng/mL | Predose, 0.5h, 1h, 2h, 3h, 4h 8h, 24h, 48h post dose |
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| Secondary | Composite PharmacoKinetics (PK) of Panobinostat and Bortezomib: Cmax | Cmax: The maximum (peak) observed plasma concentration. PK sample collection was performed in subjects who agreed to blood samplings for the PK assessments of PAN and BTZ. The order of administration of the 3 study treatment components was 1) PAN, 2) Dex, and 3) BTZ. | Pharmacokinetic Analysis Set (PAS): The PK analysis set for PAN (PAS-PAN) consisted of all subjects with at least one evaluable PK concentration of PAN. The PK analysis set for BTZ (PAS-BTZ) consisted of all subjects with at least one evaluable PK concentration of BTZ. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Predose, 0.5h, 1h, 2h, 3h, 4h 8h, 24h, 48h post dose |
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| Secondary | Composite PharmacoKinetics (PK) of Panobinostat and Bortezomib: Tmax | Tmax: The time to reach maximum (peak) plasma concentration. PK sample collection was performed in subjects who agreed to blood samplings for the PK assessments of PAN and BTZ. The order of administration of the 3 study treatment components was 1) PAN, 2) Dex, and 3) BTZ. | PAS: Pharmacokinetic Analysis Set (PAS): The PK analysis set for PAN (PAS-PAN) consisted of all subjects with at least one evaluable PK concentration of PAN. The PK analysis set for BTZ (PAS-BTZ) consisted of all subjects with at least one evaluable PK concentration of BTZ. | Posted | Median | Full Range | hour (h) | Predose, 0.5h, 1h, 2h, 3h, 4h 8h, 24h, 48h post dose |
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| Secondary | Composite PharmacoKinetics (PK) of Panobinostat and Bortezomib: T1/2 | T1/2: The elimination half-life associated with the terminal slope (Lambda_z) of a semi logarithmic concentration-time curve | PAS: Pharmacokinetic Analysis Set (PAS): The PK analysis set for PAN (PAS-PAN) consisted of all subjects with at least one evaluable PK concentration of PAN. The PK analysis set for BTZ (PAS-BTZ) consisted of all subjects with at least one evaluable PK concentration of BTZ. | Posted | Geometric Mean | Geometric Coefficient of Variation | hour (h) | Predose, 0.5h, 1h, 2h, 3h, 4h 8h, 24h 48h post dose |
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| Secondary | Composite PharmacoKinetics (PK) of Panobinostat and Bortezomib: Lambda_z | Lambda_z: The terminal elimination rate constant (h-1) | PAS: Pharmacokinetic Analysis Set (PAS): The PK analysis set for PAN (PAS-PAN) consisted of all subjects with at least one evaluable PK concentration of PAN. The PK analysis set for BTZ (PAS-BTZ) consisted of all subjects with at least one evaluable PK concentration of BTZ. | Posted | Geometric Mean | Geometric Coefficient of Variation | 1/hour (1/h) | Predose, 0.5h, 1h, 2h, 3h, 4h 8h, 24h 48h post dose |
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| Secondary | Composite PharmacoKinetics (PK) of Panobinostat and Bortezomib: CL/F | CL/F: The apparent total body clearance of drug from the plasma | PAS: Pharmacokinetic Analysis Set (PAS): The PK analysis set for PAN (PAS-PAN) consisted of all subjects with at least one evaluable PK concentration of PAN. The PK analysis set for BTZ (PAS-BTZ) consisted of all subjects with at least one evaluable PK concentration of BTZ. | Posted | Geometric Mean | Geometric Coefficient of Variation | Litre/hour (L/h) | Predose, 0.5h, 1h, 2h, 3h, 4h 8h, 24h 48h post dose |
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| Secondary | Composite PharmacoKinetics (PK) of Panobinostat and Bortezomib: Vz/F | Vz/F: The apparent volume of distribution during terminal phase (associated with Lambda_z) | PAS: Pharmacokinetic Analysis Set (PAS): The PK analysis set for PAN (PAS-PAN) consisted of all subjects with at least one evaluable PK concentration of PAN. The PK analysis set for BTZ (PAS-BTZ) consisted of all subjects with at least one evaluable PK concentration of BTZ. | Posted | Geometric Mean | Geometric Coefficient of Variation | Litre (L) | Predose, 0.5h, 1h, 2h, 3h, 4h 8h, 24h 48h post dose |
|
|
Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 985 days on panobinostat + bortezomib + dexamethasone (PAN + BTZ + Dex).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | LBH589 + Bortezomib + Dexamethasone | Participants were administered LBH589 (panobinostat)in combination with bortezomib and dexamethasone 2 weeks on/1 week off. | 0 | 31 | 14 | 31 | 31 | 31 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Coagulopathy | Blood and lymphatic system disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA (21.1) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA (21.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Face oedema | General disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Injection site reaction | General disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA (21.1) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (21.1) | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA (21.1) | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA (21.1) | Systematic Assessment |
| |
| C-reactive protein increased | Investigations | MedDRA (21.1) | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA (21.1) | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA (21.1) | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA (21.1) | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA (21.1) | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (21.1) | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA (21.1) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Hypermagnesaemia | Metabolism and nutrition disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (21.1) | Systematic Assessment |
|
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of pooled data (i.e.,data from all sites) in clinical trial or disclosure of trial results in their entirety
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862-778-8300 | novartis.email@novartis.com |
| SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Feb 27, 2018 | Oct 4, 2019 | Prot_001.pdf |
| ID | Term |
|---|---|
| D012008 | Recurrence |
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077767 | Panobinostat |
| D000069286 | Bortezomib |
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D006877 | Hydroxamic Acids |
| D006898 | Hydroxylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D006880 | Hydroxy Acids |
| D002264 | Carboxylic Acids |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D001897 | Boronic Acids |
| D000148 | Acids, Noncarboxylic |
| D000143 | Acids |
| D007287 | Inorganic Chemicals |
| D001896 | Boron Compounds |
| D011719 | Pyrazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
Not provided
Not provided
|
|
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|---|---|---|---|---|---|---|
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
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