Daratumumab for the Treatment of Patients With AL Amyloidosis

Sponsor
Boston Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT02841033
Collaborator
Janssen Pharmaceuticals (Industry)
22
1
1
39.9
0.6

Study Details

Study Description

Brief Summary

Participants with AL Amyloidosis will receive the drug daratumumab by IV infusion once weekly for two months, then every 2 weeks for four months, then once each month. Study treatment may continue until disease progression, unacceptable toxicity, or decision to withdraw from the trial. Disease evaluations will be performed every three months until disease progression.

Condition or Disease Intervention/Treatment Phase
Phase 1/Phase 2

Detailed Description

This Phase I/II study is intended to evaluate the safety and tolerability of infusion of daratumumab in AL amyloidosis, specifically with respect to infusion reactions. In addition, the investigators would like to assess organ response with respect to cardiac biomarkers and proteinuria, as well as hematologic response and time to next treatment. Participants with AL Amyloidosis will receive the drug daratumumab by IV infusion once weekly for two months, then every 2 weeks for four months, then once each month. Study treatment may continue until disease progression, unacceptable toxicity, or decision to withdraw from the trial. Disease evaluations will be performed every three months until disease progression.

Study Design

Study Type:
Interventional
Actual Enrollment :
22 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase I-II Trial of Daratumumab for the Treatment of Patients With AL Amyloidosis
Actual Study Start Date :
Mar 20, 2017
Actual Primary Completion Date :
May 28, 2020
Actual Study Completion Date :
Jul 17, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Daratumumab

Daratumumab, 16mg/kg body weight in 1000 mL for the first dose, followed by 500mL for subsequent doses, once weekly for two months, then every 2 weeks for four months, then once each month.

Drug: daratumumab
Daratumumab by IV infusion once weekly for two months, then every 2 weeks for four months, then once each month until progression or inability to tolerate.
Other Names:
  • Darzalex
  • Outcome Measures

    Primary Outcome Measures

    1. Assess the Number of Patients Who Respond to Treatment [3 months]

      Number of participants with response and ability to tolerate study treatment in each of these categories: Complete Response (CR), Very Good Partial Response (VGPR), Partial Response (PR), Stable Disease (SD), and Progressive Disease (PD). All participants were able to tolerate study treatment. Per protocol, overall response designations are a combination of hematologic response. A CR is defined as negative serum and urine immunofixation electrophoresis with normal serum free light chain ratio; a VGPR is reduction in the dFLC* to <40 mg/L, a PR is dFLC reduction by >50%; SD is not meeting criteria for CR, VGPR, PR, or PD; and PD is an increase in FLC of 50% to >100 mg/L. * "dFLC" is difference in involved and uninvolved serum Free Light-Chain levels.

    Secondary Outcome Measures

    1. Time to Next Treatment [Up to 3 years]

      Number of months from study drug initiation to starting another treatment

    2. Assess Hematologic Response Based on Blood and Urine Testing Using Standard Criteria [3 months]

      Number of patients with hematologic complete response (CR), very good partial response (VGPR), or partial response (PR). Per protocol, a hematologic CR is defined as negative serum and urine immunofixation electrophoresis with normal serum free light chain ratio; a VGPR is reduction in the dFLC* to <40 mg/L; and a PR is dFLC reduction by >50%. * "dFLC" is difference in involved and uninvolved serum free light-chain levels

    3. Assess Organ Responses Based on Standard Criteria Included in Protocol [3 months]

      Number of patients with organ response based on standard criteria included in protocol. Cardiac response is defined as: NT-proBNP response (>30% and >300 ng/L decrease in patients with a baseline NT-proBNP >650 ng/L; and/or NYHA class response (> two-class decrease if baseline NYHA class 3 or 4) Renal response is defined as: Decrease in proteinuria by > 30% or below 0.5 g/24 h without renal progression. Serum creatinine and creatinine clearance must not worsen by 25% over baseline

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Histological diagnosis of primary systemic (AL) amyloidosis:
    1. At least one tissue demonstrating positive Congo Red staining with characteristic apple green birefringence AND

    2. Evidence of a clonal plasma cell dyscrasia:

    1. Monoclonal protein in the serum and/or urine by immunofixation electrophoresis AND/OR ii. Abnormal serum free light chain assay AND/OR iii. Clonal plasma cell population in the bone marrow demonstrated by immunohistochemistry, flow cytometry or in situ hybridization AND

    2. Evidence of organ involvement other than carpal tunnel syndrome. Confirmation of tissue diagnosis at all sites of organ dysfunction is encouraged, but not required.

    • Must have relapsed after or been refractory to at least one prior treatment regimen of proven efficacy in the treatment of AL amyloidosis

    • Must be > 18 years of age.

    • Must have a performance status of 0-2 by Eastern Cooperative Oncology Group (ECOG) criteria

    • Must have adequate hepatic function as evidenced by serum bilirubin values < 2.0 mg/dL; alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) < 3x upper limit of normal (ULN).

    • Must have an absolute neutrophil count ≥1000/mm3, hemoglobin ≥7.5 g/dL, and platelet count ≥50×109/L

    Exclusion Criteria:
    • • Renal Insufficiency (CrCL <20mL/min), calculated by Cockcroft-Gault Equation Creatinine Clearance = Sex * ((140 - Age) / (SerumCreat)) * (Weight / 72) Equation parameters such as sex have two or more discrete values that may be used in the calculation. The numbers in the parentheses, e.g. (1), represent the values that will be used. The default unit of measure for weight is kilograms. Please verify that the correct unit of measure has been selected.

    • Mayo clinic cardiac biomarker stage IIIb

    • Evidence of significant cardiovascular conditions as specified below:

    • B-type Natriuretic Peptide; N-terminal pro b-type Natriuretic Peptide (NT-ProBNP) > 8500 ng/L (Mayo Stage IIIb patients are excluded)

    • New York Heart Association (NYHA) classification IIIB or IV heart failure

    • Unstable Angina, Arrhythmia, prolonged corrected QT (QTc) interval, symptomatic orthostatic hypotension, or supine systolic blood pressure < 90 mm Hg.

    • left ventricular ejection fraction (LVEF) <40%

    • Overt multiple myeloma (>30% bone marrow plasmacytosis, extensive (>2) lytic lesions, or hypercalcemia).

    • Plan for autologous stem cell transplant in the six months prior to study drug (stem cell collection is permitted during the first six months of study treatment)

    • Any form of secondary or familial (ATTR) amyloidosis

    • The presence or history of another malignancy is not allowed except for the following:

    • adequately treated basal cell or squamous cell skin cancer,

    • in situ cervical cancer,

    • adequately treated Stage I or II cancer from which the patient is currently in complete remission, any other cancer from which the patient has been disease-free for 5 years.

    • Known to be Human Immunodeficiency Virus (HIV) positivity.

    • Pregnant or nursing women. Women and men of reproductive potential may not participate unless they have agreed to use an effective contraceptive method.

    • Known chronic obstructive pulmonary disease (COPD) with a forced expiratory volume at one second (FEV1) <50% of predicted normal. Note that forced expiratory volume at one second FEV1 testing is required for patients suspected of having COPD.

    • Known moderate or severe persistent asthma within the past 2 years or currently has uncontrolled asthma of any classification

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Boston Medical Center Boston Massachusetts United States 02118

    Sponsors and Collaborators

    • Boston Medical Center
    • Janssen Pharmaceuticals

    Investigators

    • Principal Investigator: Vaishali Sanchorawala, MD, Boston Medical Center

    Study Documents (Full-Text)

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Boston Medical Center
    ClinicalTrials.gov Identifier:
    NCT02841033
    Other Study ID Numbers:
    • H-35360
    • 54767414AMY2002
    First Posted:
    Jul 21, 2016
    Last Update Posted:
    May 7, 2021
    Last Verified:
    Apr 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by Boston Medical Center
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title Daratumumab
    Arm/Group Description Daratumumab, 16mg/kg body weight in 1000 mL for the first dose, followed by 500mL for subsequent doses, once weekly for two months, then every 2 weeks for four months, then once each month for up to 24 total cycles. Daratumumab: Daratumumab by IV infusion once weekly for two months, then every 2 weeks for four months, then once each month until progression, inability to tolerate, or 24 cycles completed.
    Period Title: Overall Study
    STARTED 22
    COMPLETED 22
    NOT COMPLETED 0

    Baseline Characteristics

    Arm/Group Title Daratumumab
    Arm/Group Description Daratumumab, 16mg/kg body weight in 1000 mL for the first dose, followed by 500mL for subsequent doses, once weekly for two months, then every 2 weeks for four months, then once each month for up to 24 total cycles. Daratumumab: Daratumumab by IV infusion once weekly for two months, then every 2 weeks for four months, then once each month until progression, inability to tolerate, or 24 cycles completed.
    Overall Participants 22
    Age (years) [Median (Full Range) ]
    Median (Full Range) [years]
    63
    Sex: Female, Male (Count of Participants)
    Female
    6
    27.3%
    Male
    16
    72.7%
    Race/Ethnicity, Customized (Count of Participants)
    White Non-Hispanic
    16
    72.7%
    Black or African American
    7
    31.8%
    Asian
    0
    0%
    Hispanic or Latino
    2
    9.1%
    Other
    0
    0%
    Region of Enrollment (participants) [Number]
    United States
    22
    100%
    Time since initial diagnosis (months) [Median (Full Range) ]
    Median (Full Range) [months]
    48
    Prior therapies (lines of treatment) [Median (Full Range) ]
    Median (Full Range) [lines of treatment]
    2
    Time since last plasma cell-directed treatment (months) [Median (Full Range) ]
    Median (Full Range) [months]
    9
    dFLC (mg/L) [Median (Full Range) ]
    Median (Full Range) [mg/L]
    80.7
    Number of organ systems involved (organ systems) [Median (Full Range) ]
    Median (Full Range) [organ systems]
    2
    NYHA Class II or III (Count of Participants)
    Count of Participants [Participants]
    11
    50%

    Outcome Measures

    1. Primary Outcome
    Title Assess the Number of Patients Who Respond to Treatment
    Description Number of participants with response and ability to tolerate study treatment in each of these categories: Complete Response (CR), Very Good Partial Response (VGPR), Partial Response (PR), Stable Disease (SD), and Progressive Disease (PD). All participants were able to tolerate study treatment. Per protocol, overall response designations are a combination of hematologic response. A CR is defined as negative serum and urine immunofixation electrophoresis with normal serum free light chain ratio; a VGPR is reduction in the dFLC* to <40 mg/L, a PR is dFLC reduction by >50%; SD is not meeting criteria for CR, VGPR, PR, or PD; and PD is an increase in FLC of 50% to >100 mg/L. * "dFLC" is difference in involved and uninvolved serum Free Light-Chain levels.
    Time Frame 3 months

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Daratumumab
    Arm/Group Description Daratumumab, 16mg/kg body weight in 1000 mL for the first dose, followed by 500mL for subsequent doses, once weekly for two months, then every 2 weeks for four months, then once each month for up to 24 total cycles. Daratumumab: Daratumumab by IV infusion once weekly for two months, then every 2 weeks for four months, then once each month until progression, inability to tolerate, or 24 cycles completed.
    Measure Participants 22
    Complete Response (CR)
    5
    22.7%
    Very Good Partial Response (VGPR)
    13
    59.1%
    Partial Response (PR)
    2
    9.1%
    Stable Disease (SD)
    1
    4.5%
    Progressive Disease (PD)
    1
    4.5%
    2. Secondary Outcome
    Title Time to Next Treatment
    Description Number of months from study drug initiation to starting another treatment
    Time Frame Up to 3 years

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Daratumumab
    Arm/Group Description Daratumumab, 16mg/kg body weight in 1000 mL for the first dose, followed by 500mL for subsequent doses, once weekly for two months, then every 2 weeks for four months, then once each month for up to 24 total cycles. Daratumumab: Daratumumab by IV infusion once weekly for two months, then every 2 weeks for four months, then once each month until progression, inability to tolerate, or 24 cycles completed.
    Measure Participants 22
    <12 months
    3
    13.6%
    >12 months
    1
    4.5%
    No further treatment
    18
    81.8%
    3. Secondary Outcome
    Title Assess Hematologic Response Based on Blood and Urine Testing Using Standard Criteria
    Description Number of patients with hematologic complete response (CR), very good partial response (VGPR), or partial response (PR). Per protocol, a hematologic CR is defined as negative serum and urine immunofixation electrophoresis with normal serum free light chain ratio; a VGPR is reduction in the dFLC* to <40 mg/L; and a PR is dFLC reduction by >50%. * "dFLC" is difference in involved and uninvolved serum free light-chain levels
    Time Frame 3 months

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Daratumumab
    Arm/Group Description Daratumumab, 16mg/kg body weight in 1000 mL for the first dose, followed by 500mL for subsequent doses, once weekly for two months, then every 2 weeks for four months, then once each month for up to 24 total cycles. Daratumumab: Daratumumab by IV infusion once weekly for two months, then every 2 weeks for four months, then once each month until progression, inability to tolerate, or 24 cycles completed.
    Measure Participants 22
    Complete Response, Very Good Partial Response, or Partial Response
    20
    90.9%
    Stable Disease or Progressive Disease
    2
    9.1%
    4. Secondary Outcome
    Title Assess Organ Responses Based on Standard Criteria Included in Protocol
    Description Number of patients with organ response based on standard criteria included in protocol. Cardiac response is defined as: NT-proBNP response (>30% and >300 ng/L decrease in patients with a baseline NT-proBNP >650 ng/L; and/or NYHA class response (> two-class decrease if baseline NYHA class 3 or 4) Renal response is defined as: Decrease in proteinuria by > 30% or below 0.5 g/24 h without renal progression. Serum creatinine and creatinine clearance must not worsen by 25% over baseline
    Time Frame 3 months

    Outcome Measure Data

    Analysis Population Description
    19 evaluable patients with cardiac and/or renal involvement.
    Arm/Group Title Daratumumab
    Arm/Group Description Daratumumab, 16mg/kg body weight in 1000 mL for the first dose, followed by 500mL for subsequent doses, once weekly for two months, then every 2 weeks for four months, then once each month for up to 24 total cycles. Daratumumab: Daratumumab by IV infusion once weekly for two months, then every 2 weeks for four months, then once each month until progression, inability to tolerate, or 24 cycles completed.
    Measure Participants 19
    Count of Participants [Participants]
    14
    63.6%

    Adverse Events

    Time Frame First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
    Adverse Event Reporting Description Adverse events were assessed at every study treatment visit.
    Arm/Group Title Daratumumab
    Arm/Group Description Daratumumab, 16mg/kg body weight in 1000 mL for the first dose, followed by 500mL for subsequent doses, once weekly for two months, then every 2 weeks for four months, then once each month for up to 24 total cycles. Daratumumab: Daratumumab by IV infusion once weekly for two months, then every 2 weeks for four months, then once each month until progression, inability to tolerate, or 24 cycles completed.
    All Cause Mortality
    Daratumumab
    Affected / at Risk (%) # Events
    Total 4/22 (18.2%)
    Serious Adverse Events
    Daratumumab
    Affected / at Risk (%) # Events
    Total 11/22 (50%)
    Cardiac disorders
    Atrial fibrillation 4/22 (18.2%) 5
    Heart failure 3/22 (13.6%) 5
    Myocardial infarction (NSTEMI) 1/22 (4.5%) 1
    Gastrointestinal disorders
    Colitis 1/22 (4.5%) 1
    Diarrhea 2/22 (9.1%) 2
    Gastrointestinal hemorrhage - melena 1/22 (4.5%) 1
    Nausea 1/22 (4.5%) 1
    Upper gastrointestinal bleeding 1/22 (4.5%) 1
    General disorders
    Fever 1/22 (4.5%) 1
    Infections and infestations
    Sepsis 2/22 (9.1%) 2
    Upper respiratory infection 2/22 (9.1%) 2
    Urinary tract infection 1/22 (4.5%) 1
    Investigations
    CK increased 1/22 (4.5%) 1
    CPK increased 1/22 (4.5%) 1
    Nervous system disorders
    Syncope 2/22 (9.1%) 3
    Renal and urinary disorders
    Acute kidney injury 3/22 (13.6%) 3
    Hematuria 1/22 (4.5%) 1
    Renal and urinary disorders - other, UTI sepsis 1/22 (4.5%) 1
    Urine output decreased 1/22 (4.5%) 1
    Respiratory, thoracic and mediastinal disorders
    Dyspnea 1/22 (4.5%) 1
    Lung infection 3/22 (13.6%) 3
    Vascular disorders
    Thromboembolic event 1/22 (4.5%) 1
    Other (Not Including Serious) Adverse Events
    Daratumumab
    Affected / at Risk (%) # Events
    Total 22/22 (100%)
    Blood and lymphatic system disorders
    Lymph node pain 1/22 (4.5%) 1
    Cardiac disorders
    Atrial fibrillation 4/22 (18.2%) 4
    Chest pain - cardiac 1/22 (4.5%) 1
    Heart failure 3/22 (13.6%) 6
    Palpitations 2/22 (9.1%) 5
    Ear and labyrinth disorders
    Ear pain 3/22 (13.6%) 3
    Hearing loss 2/22 (9.1%) 2
    Tinnitus 3/22 (13.6%) 3
    Vertigo 1/22 (4.5%) 1
    Endocrine disorders
    Endocrine disorder - other, specify: TSH elevated 3/22 (13.6%) 10
    Hyperthyroidism 3/22 (13.6%) 3
    Hypothyroidism 1/22 (4.5%) 2
    Eye disorders
    Blurred vision 3/22 (13.6%) 3
    Cataract 1/22 (4.5%) 1
    Conjunctivitis 2/22 (9.1%) 2
    Dry eye 2/22 (9.1%) 2
    Eye disorders - other, specify: cloudiness 1/22 (4.5%) 2
    Eye disorders - other, specify: obstructive tear duct 1/22 (4.5%) 1
    Eye disorders - other, specify: redness 1/22 (4.5%) 1
    Eye disorders - other, specify: scleral abrasian 1/22 (4.5%) 3
    Eye disorders - other, specify: Scotoma 1/22 (4.5%) 10
    Eye disorders - other, specify: subconjunctival hemorrhage 7/22 (31.8%) 10
    Eye infection 1/22 (4.5%) 1
    Floaters 1/22 (4.5%) 4
    Watering eyes 1/22 (4.5%) 1
    Gastrointestinal disorders
    Abdominal distention 7/22 (31.8%) 16
    Abdominal pain 8/22 (36.4%) 10
    Anal hemorrhage 1/22 (4.5%) 2
    Bloating 1/22 (4.5%) 1
    Constipation 8/22 (36.4%) 16
    Dental caries 1/22 (4.5%) 1
    Diarrhea 19/22 (86.4%) 68
    Dry mouth 1/22 (4.5%) 1
    Flatulence 1/22 (4.5%) 1
    Gastroesophageal Reflux 3/22 (13.6%) 3
    Gastrointestinal disorder - other, specify: inguinal hernia 2/22 (9.1%) 2
    Gastrointestinal disorder - other, specify: black stool 1/22 (4.5%) 2
    Gastrointestinal disorder - other, specify: broken tooth 1/22 (4.5%) 1
    Gastrointestinal disorder - other, specify: H. pylori 1/22 (4.5%) 1
    Gastrointestinal disorder - other, specify: Tooth extraction 2/22 (9.1%) 2
    Gastrointestinal disorder - other, specify: ulcer - Left lateral tongue 1/22 (4.5%) 1
    Gastrointestinal disorder - other, specify: viral gastroenteritis 1/22 (4.5%) 2
    Nausea 13/22 (59.1%) 35
    Oral pain 3/22 (13.6%) 3
    Vomiting 8/22 (36.4%) 11
    General disorders
    Chest pain 1/22 (4.5%) 5
    Chest pain - cardiac 1/22 (4.5%) 1
    Chest pain - non cardiac 1/22 (4.5%) 2
    Chills 4/22 (18.2%) 4
    Edema limbs 10/22 (45.5%) 12
    Fatigue 16/22 (72.7%) 33
    Fever 7/22 (31.8%) 10
    Flu like symptoms 2/22 (9.1%) 3
    Gait disturbance 1/22 (4.5%) 2
    Localized Edema 3/22 (13.6%) 4
    Immune system disorders
    Immune system disorders - other, specify: lymphadenopathy 1/22 (4.5%) 1
    Infections and infestations
    Laryngitis 1/22 (4.5%) 1
    Pharyngitis 1/22 (4.5%) 1
    Rhinitis infective 8/22 (36.4%) 17
    Sinusitis 3/22 (13.6%) 3
    Tooth infection 1/22 (4.5%) 1
    Upper respiratory infection 11/22 (50%) 21
    Urinary tract infection 1/22 (4.5%) 1
    Vaginal infection 1/22 (4.5%) 1
    Injury, poisoning and procedural complications
    Bruising 10/22 (45.5%) 14
    Fall 2/22 (9.1%) 6
    Investigations
    Alanine aminotransferase increased (ALTT) 1/22 (4.5%) 1
    Alkaline phosphatase increased 10/22 (45.5%) 24
    Anemia 15/22 (68.2%) 42
    Anorexia 1/22 (4.5%) 1
    Aspartate aminotransferase increased (AST) 8/22 (36.4%) 18
    Cardiac troponin I increased 10/22 (45.5%) 30
    Cholesterol high 13/22 (59.1%) 32
    CPK increased 10/22 (45.5%) 31
    Creatinine Increased 17/22 (77.3%) 67
    Cystitis non-infective 1/22 (4.5%) 1
    Investigations - other, specify: Lactate dehydrogenase elevated 2/22 (9.1%) 3
    Lymphocyte count decreased 18/22 (81.8%) 76
    Neutrophil count decreased 5/22 (22.7%) 14
    Platelet count decreased 10/22 (45.5%) 18
    Serum amylase increased 2/22 (9.1%) 2
    Weight gain 2/22 (9.1%) 2
    Weight loss 1/22 (4.5%) 1
    White blood cell decreased 6/22 (27.3%) 11
    Metabolism and nutrition disorders
    Anorexia 7/22 (31.8%) 13
    Dehydration 2/22 (9.1%) 3
    Hypercalcemia 5/22 (22.7%) 11
    Hyperglycemia 4/22 (18.2%) 11
    Hyperkalemia 6/22 (27.3%) 6
    Hypermagnesemia 14/22 (63.6%) 23
    Hypertriglyceridemia 16/22 (72.7%) 61
    Hyperuricemia 13/22 (59.1%) 26
    Hypoalbuminemia 11/22 (50%) 27
    Hypocalcemia 3/22 (13.6%) 7
    Hypoglycemia 5/22 (22.7%) 8
    Hypokalemia 1/22 (4.5%) 1
    Hypomagnesemia 1/22 (4.5%) 1
    Hyponatremia 7/22 (31.8%) 10
    Hypophosphatemia 8/22 (36.4%) 29
    Metabolic and nutrition disorders - other, specify: increased appetite 2/22 (9.1%) 2
    Metabolic and nutrition disorders - other, specify: iron deficiency 8/22 (36.4%) 9
    Metabolic and nutrition disorders - other, specify: Type 2 diabetes mellitus 2/22 (9.1%) 2
    Metabolic and nutrition disorders - other, specify: vitamin B12 deficiency 1/22 (4.5%) 3
    Musculoskeletal and connective tissue disorders
    Arthalgia 7/22 (31.8%) 12
    Arthritis 1/22 (4.5%) 1
    Back pain 12/22 (54.5%) 28
    Fever 1/22 (4.5%) 1
    Flank pain 3/22 (13.6%) 3
    Generalized muscle weakness 1/22 (4.5%) 1
    Muscle weakness lower limb 1/22 (4.5%) 2
    Musculoskeletal and connective tissue disorder - other, specify: Dupuytren's contracture 1/22 (4.5%) 1
    Musculoskeletal and connective tissue disorder - other, specify: Restless legs 4/22 (18.2%) 9
    Myalgia 14/22 (63.6%) 41
    Neck pain 7/22 (31.8%) 15
    Neck stiffness 2/22 (9.1%) 2
    Pain in extremity 10/22 (45.5%) 15
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Neoplasms - other, specify: basal cell carcinoma on sternum 1/22 (4.5%) 1
    Nervous system disorders
    Concentration impairment 1/22 (4.5%) 1
    Dizziness 11/22 (50%) 24
    Dysgeusia 2/22 (9.1%) 2
    Dysphagia 1/22 (4.5%) 1
    Headache 14/22 (63.6%) 47
    Memory impairment 1/22 (4.5%) 1
    Nervous system disorders - Other, specify: Autonomic Postural Hypotension 1/22 (4.5%) 1
    Paresthesia 8/22 (36.4%) 15
    Peripheral sensory neuropathy 3/22 (13.6%) 3
    Tremor 2/22 (9.1%) 2
    Psychiatric disorders
    Agitation 1/22 (4.5%) 1
    Anxiety 2/22 (9.1%) 2
    Confusion (forgetfullness) 1/22 (4.5%) 1
    Depression 2/22 (9.1%) 2
    Insomnia 12/22 (54.5%) 15
    Irritability 1/22 (4.5%) 1
    Mania 1/22 (4.5%) 1
    Renal and urinary disorders
    Acute kidney injury 1/22 (4.5%) 1
    Chronic kidney disease 11/22 (50%) 30
    Hematuria 5/22 (22.7%) 8
    Nocturia 3/22 (13.6%) 3
    Proteinuria 2/22 (9.1%) 2
    Urinary frequency 5/22 (22.7%) 6
    Urinary incontinence 1/22 (4.5%) 1
    Urinary tract pain 1/22 (4.5%) 2
    Urinary urgency 1/22 (4.5%) 1
    Reproductive system and breast disorders
    Genital edema 1/22 (4.5%) 1
    Respiratory, thoracic and mediastinal disorders
    Allergic Rhinitis 3/22 (13.6%) 4
    Bronchospasm 1/22 (4.5%) 2
    Congestion 2/22 (9.1%) 4
    Cough 18/22 (81.8%) 46
    Dyspnea 9/22 (40.9%) 19
    Epistaxis 4/22 (18.2%) 9
    Hiccups 1/22 (4.5%) 2
    Hoarseness 6/22 (27.3%) 7
    Hypoxia 1/22 (4.5%) 1
    Laryngeal inflammation 1/22 (4.5%) 1
    Lung infection 1/22 (4.5%) 1
    Nasal congestion 9/22 (40.9%) 13
    Post nasal drip 6/22 (27.3%) 10
    Productive cough 6/22 (27.3%) 15
    Rhinorrhea 7/22 (31.8%) 13
    Sleep apnea 1/22 (4.5%) 1
    Sore throat 10/22 (45.5%) 19
    Wheezing 1/22 (4.5%) 1
    Skin and subcutaneous tissue disorders
    Alopecia 2/22 (9.1%) 2
    Dry Skin 2/22 (9.1%) 2
    Nail infection 2/22 (9.1%) 2
    Periorbital edema 1/22 (4.5%) 1
    Photosensitivity 1/22 (4.5%) 1
    Pruritus 3/22 (13.6%) 9
    Rash 1/22 (4.5%) 1
    Rash acneiform 3/22 (13.6%) 5
    Rash maculopapular 7/22 (31.8%) 18
    Skin & subcutaneous tissue disorders - other, specify: cercarial dermatitis/swimmer's itch 1/22 (4.5%) 4
    Skin and Subcutaneous tissue disorders - other, specify: Abrasion 1/22 (4.5%) 1
    Skin and Subcutaneous tissue disorders - other, specify: bug bite 3/22 (13.6%) 4
    Skin and Subcutaneous tissue disorders - other, specify: erythema 1/22 (4.5%) 1
    Skin and Subcutaneous tissue disorders - other, specify: Laceration 3/22 (13.6%) 3
    Skin and subcutaneous tissue disorders - other, specify: Skin sensitivity 1/22 (4.5%) 1
    Skin and Subcutaneous tissue disorders - other, specify: Wound 1/22 (4.5%) 1
    Skin induration 1/22 (4.5%) 1
    Surgical and medical procedures
    Surgical procedure - other, specify: Biopsy /wart removal 1/22 (4.5%) 1
    Surgical procedure - other, specify: biopsy, face, head, back 1/22 (4.5%) 1
    Surgical procedure - other, specify: pre-cancerous areas removed 2/22 (9.1%) 3
    Surgical procedure - other, specify: shaved excision of dysplastic nevus 1/22 (4.5%) 1
    Vascular disorders
    Arterial injury 1/22 (4.5%) 2
    Hot flashes 1/22 (4.5%) 1
    Hypertension 3/22 (13.6%) 4
    Hypotension 1/22 (4.5%) 1

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Vaishali Sanchorawala, MD
    Organization Boston Medical Center
    Phone 617-638-8213
    Email vaishali.sanchorawala@bmc.org
    Responsible Party:
    Boston Medical Center
    ClinicalTrials.gov Identifier:
    NCT02841033
    Other Study ID Numbers:
    • H-35360
    • 54767414AMY2002
    First Posted:
    Jul 21, 2016
    Last Update Posted:
    May 7, 2021
    Last Verified:
    Apr 1, 2021