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No objective responses observed following completion of Phase 1 dose-escalation
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This is a Phase 1/2 study designed to evaluate the safety and tolerability of BION-1301 in adults with relapsed or refractory multiple myeloma whose disease has progressed after 3 or more prior systemic therapies.
An open-label, multi-center, dose-selection Phase 1/2 study (also referred to as ADU-CL-16) evaluating BION-1301, a humanized monoclonal antibody directed against APRIL for the treatment of relapsed or refractory MM. This first-in-human study is designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and initial clinical activity of BION-1301 administered as a single agent.
The study will be conducted in 2 parts. Phase 1 is dose escalation and seeks to determine the recommended phase 2 dose (RP2D). Once an RP2D is identified, Phase 2 of the study will open and continue to evaluate the safety and preliminary efficacy of BION-1301 administered at selected dose level(s).
The population for this study will consist of adults with relapsed or refractory MM whose disease has progressed after at least 3 prior systemic therapies. BION-1301 will be administered in 28-day cycles; the dosing interval will be once every two weeks (Q2W).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BION-1301 | Experimental | BION-1301 will be administered once every 2 weeks as an intravenous (IV) infusion. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BION-1301 | Biological | a solution for intravenous (IV) administration, diluted and administered Q2W |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety (Phase 1) | Number of patients reporting treatment-related adverse events that qualify as dose-limiting toxicities (DLTs) of BION-1301 as a single agent | 28 days following first administration of BION-1301 |
| Recommended Phase 2 Dose (Phase 1) | Recommended Phase 2 Dose RP2D of BION-1301 when administered as a single-agent | Approximately 2 years |
| Biomarkers (Phase 1 and 2) | Biomarkers such as soluble a proliferation inducing ligand (APRIL; TNFSF13); soluble B cell maturation antigen (BCMA; TNFRSF17) | Baseline and approximately 2 years |
| Bioanalytical Measures (Phase 1 and Phase 2) | Relative change in serum and urine M-protein levels defined as the maximum reduction from baseline | Baseline and approximately 2 years |
| Safety Profile (Phase 2) | BION-1301 safety profile based on incidence of TEAEs (treatment emergent adverse events), changes in safety parameters, and unacceptable toxicities | 28 days |
| Response Rate (Phase 2) | Objective response rate (ORR) based on International Myeloma Working Group (IMWG) uniform response criteria of stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR) | Approximately 30 months |
| Progression-Free Survival (Phase 2) |
Not provided
Not provided
Key Inclusion Criteria:
Individuals eligible to participate in this study must meet the following key criteria and additional criteria as specified in the protocol:
Male or female, aged ≥ 18 years
Confirmed diagnosis of MM per IMWG criteria
Measurable disease as defined by one or more of the following:
Relapsed or refractory (Rajkumar, 2011) to 3 or more different prior lines of therapy for MM, including immunomodulatory drugs (IMiDs), proteasome inhibitors (PIs), chemotherapies, or monoclonal antibodies, and not a candidate for, or intolerant to established therapy known to provide clinical benefit.
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 - 1
Adequate organ and marrow function at Screening, as defined by the study protocol.
Key Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| James R. Berenson, MD, Inc | West Hollywood | California | 90069 | United States | ||
| Winship Cancer Institute/Emory University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21292775 | Background | Rajkumar SV, Harousseau JL, Durie B, Anderson KC, Dimopoulos M, Kyle R, Blade J, Richardson P, Orlowski R, Siegel D, Jagannath S, Facon T, Avet-Loiseau H, Lonial S, Palumbo A, Zonder J, Ludwig H, Vesole D, Sezer O, Munshi NC, San Miguel J; International Myeloma Workshop Consensus Panel 1. Consensus recommendations for the uniform reporting of clinical trials: report of the International Myeloma Workshop Consensus Panel 1. Blood. 2011 May 5;117(18):4691-5. doi: 10.1182/blood-2010-10-299487. Epub 2011 Feb 3. |
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Subject enrollment was stopped prematurely due to the sponsor's decision to terminate the study. Therefore, the study did not proceed to the Phase 2 portion of the study protocol. All reporting groups are for Phase 1 only.
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| ID | Title | Description |
|---|---|---|
| FG000 | BION-1301 50 mg Q2W | 50 mg BION-1301 will be administered once every 2 weeks as an intravenous (IV) infusion. |
| FG001 | BION-1301 150 mg Q2W | 150 mg BION-1301 will be administered once every 2 weeks as an IV infusion. |
| FG002 | BION-1301 450 mg Q2W | 450 mg BION-1301 will be administered once every 2 weeks as an IV infusion. |
| FG003 | BION-1301 1350 mg Q2W | 1350 mg BION-1301 will be administered once every 2 weeks as an IV infusion. |
| FG004 | BION-1301 2700 mg Q2W | 2700 mg BION-1301 will be administered once every 2 weeks as an IV infusion. |
| FG005 | BION-1301 1350 mg QW*8W->Q2W | 1350 mg BION-1301 will be administered as an IV infusion once per week for up to 8 weeks, followed by dosing once every 2 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All participants who received at least one dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Phase 1 BION-1301 | BION-1301 will be administered once every 2 weeks as an intravenous (IV) infusion. BION-1301: a solution for intravenous (IV) administration, diluted and administered Q2W |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| 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 | Safety (Phase 1) | Number of patients reporting treatment-related adverse events that qualify as dose-limiting toxicities (DLTs) of BION-1301 as a single agent | Safety Analysis Set (all participants who received any amount of study drug) in the Phase 1 part of the study. | Posted | Count of Participants | Participants | 28 days following first administration of BION-1301 |
|
From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | BION-1301 50 mg Q2W | 50 mg BION-1301 will be administered once every 2 weeks as an intravenous (IV) infusion. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Asthenia | General disorders | MedDRA (20.1) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA Version 20.1 | Systematic Assessment |
ADU-CL-16 was terminated early leading to a small number of Phase 1 subjects analyzed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chinook Therapeutics, Inc. (formerly Aduro Biotech, Inc.) | Chinook Therapeutics, Inc. | 206-485-7051 | clinicaltrials@chinooktx.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 13, 2018 | Jun 19, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 18, 2019 | Jun 19, 2020 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
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Single arm study
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Progression-free survival (PFS) defined as time from first dose of study drug to date of first tumor progression or death due to any cause
| Approximately 30 months |
| Overall Survival (Phase 2) | Overall survival (OS) defined as the time from first dose of study drug to date of death due to any cause | Approximately 30 months |
| Atlanta |
| Georgia |
| 30322 |
| United States |
| Ohio State University Wexner Medical Center James Cancer Hospital | Columbus | Ohio | 43210 | United States |
| UPMC (University of Pittsburgh Medical Center) Hillman Cancer Center | Pittsburgh | Pennsylvania | 15232 | United States |
| Virginia Cancer Specialists | Fairfax | Virginia | 22031 | United States |
| Swedish Medical Center | Seattle | Washington | 98104 | United States |
| Froedtert Hospital & The Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG002 | BION-1301 450 mg Q2W | 450 mg BION-1301 will be administered once every 2 weeks as an IV infusion. |
| OG003 | BION-1301 1350 mg Q2W | 1350 mg BION-1301 will be administered once every 2 weeks as an IV infusion. |
| OG004 | BION-1301 2700 mg Q2W | 2700 mg BION-1301 will be administered once every 2 weeks as an IV infusion. |
| OG005 | BION-1301 1350 mg QW*8W->Q2W | 1350 mg BION-1301 will be administered as an IV infusion once per week for up to 8 weeks, followed by dosing once every 2 weeks. |
|
|
| Primary | Recommended Phase 2 Dose (Phase 1) | Recommended Phase 2 Dose RP2D of BION-1301 when administered as a single-agent | Study was terminated early. No outcome measures were assessed. | Posted | Approximately 2 years |
|
|
| Primary | Biomarkers (Phase 1 and 2) | Biomarkers such as soluble a proliferation inducing ligand (APRIL; TNFSF13); soluble B cell maturation antigen (BCMA; TNFRSF17) | Study was terminated early and Phase 2 did not enroll. BCMA was an exploratory endpoint and was not reported. | Posted | Median | Full Range | % change relative to baseline | Baseline and approximately 2 years |
|
|
|
| Primary | Bioanalytical Measures (Phase 1 and Phase 2) | Relative change in serum and urine M-protein levels defined as the maximum reduction from baseline | Some laboratory tests were not performed for some of the participants. Therefore, the number analyzed does not always match the overall number of participants analyzed. Study was terminated early and Phase 2 did not enroll. | Posted | Median | Inter-Quartile Range | percentage change | Baseline and approximately 2 years |
|
|
|
| Primary | Safety Profile (Phase 2) | BION-1301 safety profile based on incidence of TEAEs (treatment emergent adverse events), changes in safety parameters, and unacceptable toxicities | Study was terminated early and Phase 2 was not enrolled. Safety profile was not assessed. | Posted | 28 days |
|
|
| Primary | Response Rate (Phase 2) | Objective response rate (ORR) based on International Myeloma Working Group (IMWG) uniform response criteria of stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR) | Study was terminated early and Phase 2 was not enrolled. Objective response rate was not assessed. | Posted | Approximately 30 months |
|
|
| Primary | Progression-Free Survival (Phase 2) | Progression-free survival (PFS) defined as time from first dose of study drug to date of first tumor progression or death due to any cause | Study was terminated early and Phase 2 did not enroll. Progression-free survival was not assessed. | Posted | Approximately 30 months |
|
|
| Primary | Overall Survival (Phase 2) | Overall survival (OS) defined as the time from first dose of study drug to date of death due to any cause | Study was terminated early and Phase 2 did not enroll. Overall survival was not assessed. | Posted | Approximately 30 months |
|
|
| 1 |
| 4 |
| 3 |
| 4 |
| 4 |
| 4 |
| EG001 | BION-1301 150 mg Q2W | 150 mg BION-1301 will be administered once every 2 weeks as an IV infusion. | 2 | 3 | 1 | 3 | 3 | 3 |
| EG002 | BION-1301 450 mg Q2W | 450 mg BION-1301 will be administered once every 2 weeks as an IV infusion. | 0 | 4 | 1 | 4 | 4 | 4 |
| EG003 | BION-1301 1350 mg Q2W | 1350 mg BION-1301 will be administered once every 2 weeks as an IV infusion. | 2 | 4 | 2 | 4 | 3 | 4 |
| EG004 | BION-1301 2700 mg Q2W | 2700 mg BION-1301 will be administered once every 2 weeks as an IV infusion. | 1 | 3 | 0 | 3 | 2 | 3 |
| EG005 | BION-1301 1350 mg QW*8W->Q2W | 1350 mg BION-1301 will be administered as an IV infusion once per week for up to 8 weeks, followed by dosing once every 2 weeks. | 1 | 3 | 1 | 3 | 3 | 3 |
| Sudden death | General disorders | MedDRA (20.1) | Systematic Assessment |
|
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
|
| Lung infection | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
|
| Staphylococcal sepsis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | MedDRA (20.1) | Systematic Assessment |
|
| Renal failure | Renal and urinary disorders | MedDRA (20.1) | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
|
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
|
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
|
| Compartment syndrome | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
|
| Disease progression | General disorders | MedDRA (20.1) | Systematic Assessment |
|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA (20.1) | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA (20.1) | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (20.1) | Systematic Assessment |
|
| Chills | General disorders | MedDRA (20.1) | Systematic Assessment |
|
| Localised oedema | General disorders | MedDRA (20.1) | Systematic Assessment |
|
| Non-cardiac chest pain | General disorders | MedDRA (20.1) | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA (20.1) | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA Version 20.1 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
|
| Pain in jaw | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
|
| Osteopenia | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
|
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
|
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
|
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
|
| Hypermagnesaemia | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
|
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
|
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
|
| Conjunctivitis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
|
| Hordeolum | Infections and infestations | MedDRA Version 20.1 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
|
| Rhinovirus infection | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA (20.1) | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA (20.1) | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (20.1) | Systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA (20.1) | Systematic Assessment |
|
| Lymphopenia | Blood and lymphatic system disorders | MedDRA (20.1) | Systematic Assessment |
|
| Pancytopenia | Blood and lymphatic system disorders | MedDRA (20.1) | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
|
| Sneezing | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | MedDRA (20.1) | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA (20.1) | Systematic Assessment |
|
| Incontinence | Renal and urinary disorders | MedDRA (20.1) | Systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | MedDRA (20.1) | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA (20.1) | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA (20.1) | Systematic Assessment |
|
| Haematoma | Vascular disorders | MedDRA Version 20.1 | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
|
| Muscle spasticity | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
|
| Diplopia | Eye disorders | MedDRA (20.1) | Systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA (20.1) | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
|
| Foot fracture | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
|
| Rib fracture | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA (20.1) | Systematic Assessment |
|
| Activated partial thromboplastin time prolonged | Investigations | MedDRA (20.1) | Systematic Assessment |
|
| Blood fibrinogen decreased | Investigations | MedDRA (20.1) | Systematic Assessment |
|
| International normalised ratio increased | Investigations | MedDRA (20.1) | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA (20.1) | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA Version 20.1 | Systematic Assessment |
|
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA Version 20.1 | Systematic Assessment |
|
| Sinus bradycardia | Cardiac disorders | MedDRA (20.1) | Systematic Assessment |
|
| Head and neck cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.1) | Systematic Assessment |
|
Disclosure restriction - study results first published in a joint multi-center paper unless (a) no multi-center publication, or (b) ≥18 months has passed since completion of the study. Thereafter, Investigator may publish provided that Investigator: (i) provides a copy of the publication to Aduro ≥ 60 days in advance of submission for publication; (ii) deletes Aduro Confidential Information (other than the Study results) and (iii) submission may be delayed up to 90 days to permit IP filings.
| 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 |
|
| BCMA |
|
|
| Serum Albumin (g/dL) |
|
|
| Serum Alpha-1 Globulin (g/dL) |
|
|
| Serum Alpha-2 Globulin (g/dL) |
|
|
| Serum Beta Globulin (g/dL) |
|
|
| Serum Gamma Globulin (g/dL) |
|
|
| Serum Immunoglobulin A (g/L) |
|
|
| Serum Immunoglobulin G (g/L) |
|
|
| Serum Immunoglobulin M (g/L) |
|
|
| Serum Kappa Light Chain, Free (mg/dL) |
|
|
| Serum Kappa LtChain,Free/LambdaLtChain,Free(RATIO) |
|
|
| Serum Lambda Light Chain, Free (mg/dL) |
|
|
| Serum Monoclonal Protein Spike (g/dL) |
|
|
| Serum Protein (g/dL) |
|
|
| Urine Albumin (mg/dL) |
|
|
| Urine Alpha-1 Globulin (mg/dL) |
|
|
| Urine Alpha-2 Globulin (mg/dL) |
|
|
| Urine Beta Globulin (mg/dL) |
|
|
| Urine Gamma Globulin (mg/dL) |
|
|
| Urine Monoclonal Protein Spike (%) |
|
|
| Urine Protein (mg/dL) |
|
|
| Urine Protein, Calculated (mg/24hr) |
|
|