Not provided
Not provided
Not provided
Not provided
Not provided
The study was terminated by the Sponsor for administrative reasons and not due to any safety concerns.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study was to determine the safety and maximum tolerated dose (MTD) of ALXN6000 (samalizumab) in treating relapsing or refractory B-cell chronic lymphocytic leukemia (B-CLL) or multiple myeloma (MM) and to study how samalizumab may help the immune system fight tumors that express CD200.
This was an open-label multicenter study for participants with relapsing or refractory B-CLL or MM. The study was planned to be conducted in 2 parts: Part A and Part B. Both parts were to evaluate safety, pharmacokinetics (PK), pharmacodynamics (PD), and efficacy (to the extent possible) of samalizumab in the target participant population. Part A was designed as the open-label, intravenous (IV) single dose-escalation portion of the study to determine the MTD and to assess the overall safety of different dose levels of up to 4 IV doses of samalizumab in participants with either refractory or relapsing B-CLL or MM. Initially, at least 3 participants would be enrolled into a cohort until a dose-limiting toxicity (DLT) was reached. If any 1 of the initial 3 participants in the cohort experienced a DLT, the cohort would be expanded to at least 6 participants.
After determination of the MTD in Part A, the Sponsor was to review the safety, PK, and relevant PD data to determine the dosing administration schedule for Part B. However, no participants were enrolled for Part B, as the study was terminated by the Sponsor for administrative reasons.
Participant enrollment in Cohort 7 (600 milligrams per square meter [mg/m^2] dose level), Part A, was halted after enrollment of the first participant. The study was terminated by the Sponsor for administrative reasons and not due to any safety concerns. Participants who were on study at the time of study termination were allowed to continue until the expiry date of the drug lot being used and then were followed for 30 (±1) days per protocol. The study was terminated by the Sponsor at that time. Part B of the study was not conducted.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Samalizumab | Experimental | All doses of samalizumab were individualized based on the participant's body surface area in mg/m^2 based on screening height and weight. Participants were assigned to a dose cohort, ranging from 50 to 600 mg/m^2, and received a single IV dose of samalizumab. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose. If no participants enrolled into a cohort experienced a DLT, escalation to the next dose level occurred with a new cohort. If any 1 of the initial 3 participants in the cohort experienced a DLT, the cohort was expanded to at least 6 participants. Then, if less than one third of participants within the cohort experienced a DLT, escalation to the next dose level occurred with a new cohort. Dose cohorts were enrolled sequentially. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Samalizumab | Drug | Samalizumab is a humanized anti-CD200 monoclonal antibody. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Tolerated Dose (MTD) Of Samalizumab | The MTD was to be defined as the dose level at which less than one-third of participants experienced a dose-limiting toxicity (DLT) during the first 28 days of treatment and immediately below the dose at which at least one-third of participants experienced a DLT. A DLT was defined as any Grade 3 or greater toxicity according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 not related to the disease under study or its sequelae that occurred in the first 28 days after dosing in Cycle 1. The NCI CTCAE grading system for the organ of involvement was used to classify severity of adverse autoimmune reactions. | From first dose through 10 weeks after the last dose |
| Number Of Participants With Treatment-Emergent Adverse Events (TEAEs) | A TEAE was defined as any event not present prior to exposure to samalizumab or any event already present that worsened in either intensity or frequency following exposure to samalizumab. A treatment-emergent serious adverse event was defined as any event that resulted in death, was immediately life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or was a congenital anomaly/birth defect. A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module. | From first dose through 10 weeks after the last dose |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Of Bound Samalizumab On B-Cell Chronic Lymphocytic Leukemia (B-CLL) Cells In Participants With B-CLL At Baseline (Predose) And Day 1 (Postdose) | Bound samalizumab was detected using a monoclonal antibody (mAb) specific for samalizumab. The binding of samalizumab to CD200 on peripheral B-CLL tumor cells was evaluated in participants with B-CLL by flow cytometry and expressed as the percent of B-CLL cells bound by samalizumab. For participants with insufficient numbers of peripheral B-CLL for analysis, the samples were documented as "unevaluable" and an analysis was not performed. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tucson | Arizona | 85719 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31443741 | Derived | Mahadevan D, Lanasa MC, Farber C, Pandey M, Whelden M, Faas SJ, Ulery T, Kukreja A, Li L, Bedrosian CL, Zhang X, Heffner LT. Phase I study of samalizumab in chronic lymphocytic leukemia and multiple myeloma: blockade of the immune checkpoint CD200. J Immunother Cancer. 2019 Aug 23;7(1):227. doi: 10.1186/s40425-019-0710-1. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Samalizumab 50 mg/m^2 | Participants assigned to this dose cohort received a single intravenous (IV) dose of samalizumab 50 mg/m^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose. |
| FG001 | Samalizumab 100 mg/m^2 | Participants assigned to this dose cohort received a single IV dose of samalizumab 100 mg/m^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose. |
| FG002 | Samalizumab 200 mg/m^2 | Participants assigned to this dose cohort received a single IV dose of samalizumab 200 mg/m^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose. |
| FG003 | Samalizumab 300 mg/m^2 | Participants assigned to this dose cohort received a single IV dose of samalizumab 300 mg/m^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose. |
| FG004 | Samalizumab 400 mg/m^2 | Participants assigned to this dose cohort received a single IV dose of samalizumab 400 mg/m^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose. |
| FG005 | Samalizumab 500 mg/m^2 | Participants assigned to this dose cohort received a single IV dose of samalizumab 500 mg/m^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose. |
| FG006 | Samalizumab 600 mg/m^2 | Participants assigned to this dose cohort received a single IV dose of samalizumab 600 mg/m^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All participants who received at least 1 dose of samalizumab.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Samalizumab | All doses of samalizumab were individualized based on the participant's body surface area in mg/m^2 based on screening height and weight. Participants were assigned to a dose cohort, ranging from 50 to 600 mg/m^2, and received a single IV dose of samalizumab. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Maximum Tolerated Dose (MTD) Of Samalizumab | The MTD was to be defined as the dose level at which less than one-third of participants experienced a dose-limiting toxicity (DLT) during the first 28 days of treatment and immediately below the dose at which at least one-third of participants experienced a DLT. A DLT was defined as any Grade 3 or greater toxicity according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 not related to the disease under study or its sequelae that occurred in the first 28 days after dosing in Cycle 1. The NCI CTCAE grading system for the organ of involvement was used to classify severity of adverse autoimmune reactions. | All participants who received at least 1 dose of samalizumab. | Posted | Number | mg/m^2 | From first dose through 10 weeks after the last dose |
|
From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
Not provided
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 | Samalizumab 50 mg/m^2 | Participants assigned to this dose cohort received a single IV dose of samalizumab 50 mg/m^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Visual acuity reduced | Eye disorders | MedDRA (11.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (11.0) | Systematic Assessment |
The study was terminated by the Sponsor for administrative reasons and not due to any safety concerns. Part B of the study was not conducted.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alexion Pharmaceuticals Inc. | Alexion Pharmaceuticals Inc. | 855-752-2356 | clinicaltrials@alexion.com |
Not provided
| ID | Term |
|---|---|
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| D009101 | Multiple Myeloma |
| D007938 | Leukemia |
| ID | Term |
|---|---|
| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| C000709706 | samalizumab |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Baseline (Predose) and Day 1 (Postdose) |
| Density Of B-CLL Cells Bound At Baseline (Predose) And Day 1 (Postdose) | Bound samalizumab was detected using a mAb specific for samalizumab. The binding of samalizumab to CD200 on peripheral B-CLL tumor cells was evaluated in participants with B-CLL by flow cytometry and expressed as mean channel fluorescence intensity (MFI) of bound samalizumab to provide an indication of the density of bound samalizumab on target B-CLL cells. For participants with insufficient numbers of peripheral B-CLL for analysis, the samples were documented as "unevaluable" and an analysis was not performed. | Baseline (Predose) and Day 1 (Postdose) |
| Clinical Response Of Participants With B-CLL Following Samalizumab Dosing Using Modified NCI Working Group Response Criteria For ORR Rate | Clinical responses assessed using the Modified NCI Working Group Response Criteria. Overall Response Rate (ORR)=percentage of participants who maintained best response for ≥1 month after achieving that best response and having complete response (CR), partial response (PR), nodular partial response (nPR), or stable disease (SD). CR=absence of lymphadenopathy, hepatomegaly, or splenomegaly and normal complete blood count (CBC). PR=≥50% decrease in peripheral lymphocyte count or ≥50% reduction in lymphadenopathy, hepatomegaly, or splenomegaly and normal or 50% improvement over baseline CBC. nPR=CR participants with lymphoid aggregates. Progressive disease (PD)=>50% increase for >2 lymph nodes, spleen and/or liver size, or absolute number of circulating lymphocytes; or new lymph nodes. SD=have not achieved CR, PR, or nPR or have not shown PD. Features must be exhibited for ≥1month for CR/PR. Number of participants with individual best response and ORR for each cohort is presented. | From first dose through 10 weeks after the last dose |
| Clinical Response Of Participants With Multiple Myeloma (MM) Following Dosing With Samalizumab | Clinical responses of samalizumab were assessed using the International Myeloma Working Group Uniform Response Criteria. ORR was defined as the percentage of participants who had either stringent complete response, complete response, very good partial response, or partial response on 2 consecutive assessments made at any time before the administration of any new therapy. The number of participants with the individual best response and ORR for each cohort is presented. | From first dose through 10 weeks after the last dose |
| Atlanta |
| Georgia |
| 30322 |
| United States |
| Morristown | New Jersey | 07962 | United States |
| Durham | North Carolina | 27710 | United States |
| Withdrawal by Subject |
|
| Lack of Efficacy |
|
| Investigator Considered it Advisable |
|
| Death |
|
| Positive Human Anti-human Antibody |
|
| Follow-up Visits Not Completed |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Type of Malignancy | Count of Participants | Participants |
|
|
|
| Primary | Number Of Participants With Treatment-Emergent Adverse Events (TEAEs) | A TEAE was defined as any event not present prior to exposure to samalizumab or any event already present that worsened in either intensity or frequency following exposure to samalizumab. A treatment-emergent serious adverse event was defined as any event that resulted in death, was immediately life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or was a congenital anomaly/birth defect. A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module. | All participants who received at least 1 dose of samalizumab. | Posted | Number | participants | From first dose through 10 weeks after the last dose |
|
|
|
| Secondary | Percent Of Bound Samalizumab On B-Cell Chronic Lymphocytic Leukemia (B-CLL) Cells In Participants With B-CLL At Baseline (Predose) And Day 1 (Postdose) | Bound samalizumab was detected using a monoclonal antibody (mAb) specific for samalizumab. The binding of samalizumab to CD200 on peripheral B-CLL tumor cells was evaluated in participants with B-CLL by flow cytometry and expressed as the percent of B-CLL cells bound by samalizumab. For participants with insufficient numbers of peripheral B-CLL for analysis, the samples were documented as "unevaluable" and an analysis was not performed. | All participants with B-CLL who had evaluable assessments for bound samalizumab were included in the analysis. No participants with B-CLL received samalizumab at the 600 mg/m^2 dose level. | Posted | Median | Full Range | percentage of B-CLL cells bound | Baseline (Predose) and Day 1 (Postdose) |
|
|
|
| Secondary | Density Of B-CLL Cells Bound At Baseline (Predose) And Day 1 (Postdose) | Bound samalizumab was detected using a mAb specific for samalizumab. The binding of samalizumab to CD200 on peripheral B-CLL tumor cells was evaluated in participants with B-CLL by flow cytometry and expressed as mean channel fluorescence intensity (MFI) of bound samalizumab to provide an indication of the density of bound samalizumab on target B-CLL cells. For participants with insufficient numbers of peripheral B-CLL for analysis, the samples were documented as "unevaluable" and an analysis was not performed. | All participants with B-CLL who had evaluable assessments for bound samalizumab were included in the analysis. No participants with B-CLL received samalizumab at the 600 mg/m^2 dose level. | Posted | Median | Full Range | mean channel fluorescent intensity | Baseline (Predose) and Day 1 (Postdose) |
|
|
|
| Secondary | Clinical Response Of Participants With B-CLL Following Samalizumab Dosing Using Modified NCI Working Group Response Criteria For ORR Rate | Clinical responses assessed using the Modified NCI Working Group Response Criteria. Overall Response Rate (ORR)=percentage of participants who maintained best response for ≥1 month after achieving that best response and having complete response (CR), partial response (PR), nodular partial response (nPR), or stable disease (SD). CR=absence of lymphadenopathy, hepatomegaly, or splenomegaly and normal complete blood count (CBC). PR=≥50% decrease in peripheral lymphocyte count or ≥50% reduction in lymphadenopathy, hepatomegaly, or splenomegaly and normal or 50% improvement over baseline CBC. nPR=CR participants with lymphoid aggregates. Progressive disease (PD)=>50% increase for >2 lymph nodes, spleen and/or liver size, or absolute number of circulating lymphocytes; or new lymph nodes. SD=have not achieved CR, PR, or nPR or have not shown PD. Features must be exhibited for ≥1month for CR/PR. Number of participants with individual best response and ORR for each cohort is presented. | All participants with B-CLL who received at least 1 dose of samalizumab. | Posted | Count of Participants | Participants | From first dose through 10 weeks after the last dose |
|
|
|
| Secondary | Clinical Response Of Participants With Multiple Myeloma (MM) Following Dosing With Samalizumab | Clinical responses of samalizumab were assessed using the International Myeloma Working Group Uniform Response Criteria. ORR was defined as the percentage of participants who had either stringent complete response, complete response, very good partial response, or partial response on 2 consecutive assessments made at any time before the administration of any new therapy. The number of participants with the individual best response and ORR for each cohort is presented. | All participants with MM who received at least 1 dose of samalizumab. | Posted | Count of Participants | Participants | From first dose through 10 weeks after the last dose |
|
|
|
| 0 |
| 4 |
| 1 |
| 4 |
| 4 |
| 4 |
| EG001 | Samalizumab 100 mg/m^2 | Participants assigned to this dose cohort received a single IV dose of samalizumab 100 mg/m^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose. | 1 | 5 | 2 | 5 | 5 | 5 |
| EG002 | Samalizumab 200 mg/m^2 | Participants assigned to this dose cohort received a single IV dose of samalizumab 200 mg/m^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose. | 0 | 3 | 0 | 3 | 3 | 3 |
| EG003 | Samalizumab 300 mg/m^2 | Participants assigned to this dose cohort received a single IV 300 mg/m^2 dose of samalizumab. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose. | 0 | 3 | 1 | 3 | 3 | 3 |
| EG004 | Samalizumab 400 mg/m^2 | Participants assigned to this dose cohort received a single IV dose of samalizumab 400 mg/m^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose. | 0 | 3 | 1 | 3 | 3 | 3 |
| EG005 | Samalizumab 500 mg/m^2 | Participants assigned to this dose cohort received a single IV dose of samalizumab 500 mg/m^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose. | 0 | 7 | 1 | 7 | 6 | 7 |
| EG006 | Samalizumab 600 mg/m^2 | Participants assigned to this dose cohort received a single IV dose of samalizumab 600 mg/m^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose. | 0 | 1 | 0 | 1 | 1 | 1 |
| Ascites | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (11.0) | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
| Respiratory syncytial virus infection | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Systematic Assessment |
|
| Hemorrhage intracranial | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Renal failure | Renal and urinary disorders | MedDRA (11.0) | Systematic Assessment |
|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Cholecystectomy | Surgical and medical procedures | MedDRA (11.0) | Systematic Assessment |
|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Pericardial effusion | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| Conjunctival haemorrhage | Eye disorders | MedDRA (11.0) | Systematic Assessment |
|
| Eye irritation | Eye disorders | MedDRA (11.0) | Systematic Assessment |
|
| Eye pain | Eye disorders | MedDRA (11.0) | Systematic Assessment |
|
| Night blindness | Eye disorders | MedDRA (11.0) | Systematic Assessment |
|
| Photophobia | Eye disorders | MedDRA (11.0) | Systematic Assessment |
|
| Photopsia | Eye disorders | MedDRA (11.0) | Systematic Assessment |
|
| Retinal haemorrhage | Eye disorders | MedDRA (11.0) | Systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA (11.0) | Systematic Assessment |
|
| Vitreous floaters | Eye disorders | MedDRA (11.0) | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Colitis | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Impaired gastric emptying | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Inguinal hernia | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA (11.0) | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA (11.0) | Systematic Assessment |
|
| Chills | General disorders | MedDRA (11.0) | Systematic Assessment |
|
| Face oedema | General disorders | MedDRA (11.0) | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA (11.0) | Systematic Assessment |
|
| Infusion site extravasation | General disorders | MedDRA (11.0) | Systematic Assessment |
|
| Injection site extravasation | General disorders | MedDRA (11.0) | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA (11.0) | Systematic Assessment |
|
| Pain | General disorders | MedDRA (11.0) | Systematic Assessment |
|
| Peripheral coldness | General disorders | MedDRA (11.0) | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (11.0) | Systematic Assessment |
|
| Cholecystitis | Hepatobiliary disorders | MedDRA (11.0) | Systematic Assessment |
|
| Cholelithiasis | Hepatobiliary disorders | MedDRA (11.0) | Systematic Assessment |
|
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA (11.0) | Systematic Assessment |
|
| Hypersensitivity | Immune system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Hypogammaglobulinaemia | Immune system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
| Candidiasis | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
| Folliculitis | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
| Infected epidermal cyst | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
| Localised infection | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
| Pneumococcal bacteraemia | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
| Respiratory tract infection | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
| Tooth abscess | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
| Viral infection | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA (11.0) | Systematic Assessment |
|
| Excoriation | Injury, poisoning and procedural complications | MedDRA (11.0) | Systematic Assessment |
|
| Medication error | Injury, poisoning and procedural complications | MedDRA (11.0) | Systematic Assessment |
|
| Procedural pain | Injury, poisoning and procedural complications | MedDRA (11.0) | Systematic Assessment |
|
| Skin laceration | Injury, poisoning and procedural complications | MedDRA (11.0) | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA (11.0) | Systematic Assessment |
|
| Blood viscosity increased | Investigations | MedDRA (11.0) | Systematic Assessment |
|
| Haemoglobin | Investigations | MedDRA (11.0) | Systematic Assessment |
|
| Platelet count | Investigations | MedDRA (11.0) | Systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA (11.0) | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | MedDRA (11.0) | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA (11.0) | Systematic Assessment |
|
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA (11.0) | Systematic Assessment |
|
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA (11.0) | Systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (11.0) | Systematic Assessment |
|
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA (11.0) | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (11.0) | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Systematic Assessment |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Systematic Assessment |
|
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA (11.0) | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA (11.0) | Systematic Assessment |
|
| Micturition urgency | Renal and urinary disorders | MedDRA (11.0) | Systematic Assessment |
|
| Pollakiuria | Renal and urinary disorders | MedDRA (11.0) | Systematic Assessment |
|
| Urinary hesitation | Renal and urinary disorders | MedDRA (11.0) | Systematic Assessment |
|
| Urinary incontinence | Renal and urinary disorders | MedDRA (11.0) | Systematic Assessment |
|
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | MedDRA (11.0) | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (11.0) | Systematic Assessment |
|
| Blood blister | Skin and subcutaneous tissue disorders | MedDRA (11.0) | Systematic Assessment |
|
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA (11.0) | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (11.0) | Systematic Assessment |
|
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA (11.0) | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (11.0) | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA (11.0) | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA (11.0) | Systematic Assessment |
|
| Dermabrasion | Surgical and medical procedures | MedDRA (11.0) | Systematic Assessment |
|
| Haematoma | Vascular disorders | MedDRA (11.0) | Systematic Assessment |
|
| Phlebitis | Vascular disorders | MedDRA (11.0) | Systematic Assessment |
|
Not provided
Not provided
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D054219 | Neoplasms, Plasma Cell |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006474 | Hemorrhagic Disorders |
| Treatment-emergent Serious Adverse Event |
|
| Discontinued due to Adverse Events |
|
| Adverse Events Leading to Death |
|
| Day 1 (Postdose) |
|
| Day 1 (Postdose) |
|
| Partial Response |
|
| Stable Disease |
|
| Not Evaluable |
|
| ORR |
|
| Stable Disease |
|
| Not Evaluable |
|
| ORR |
|