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Trial record 1 of 1 for:    daratumumab sanchorawala
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Daratumumab for the Treatment of Patients With AL Amyloidosis

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2017 by Boston Medical Center
Sponsor:
Collaborator:
Janssen Pharmaceuticals
Information provided by (Responsible Party):
Vaishali Sanchorawala, Boston Medical Center
ClinicalTrials.gov Identifier:
NCT02841033
First received: June 14, 2016
Last updated: March 28, 2017
Last verified: March 2017
  Purpose
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 Intervention Phase
AL Amyloidosis
Drug: daratumumab
Phase 1
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: A Phase I-II Trial of Daratumumab for the Treatment of Patients With AL Amyloidosis

Resource links provided by NLM:


Further study details as provided by Boston Medical Center:

Primary Outcome Measures:
  • Assess frequency and severity of side effects and number of patients who respond to treatment [ Time Frame: 3 months ]
    number of participants with response and ability to tolerate study treatment


Secondary Outcome Measures:
  • time to next treatment [ Time Frame: 5 years ]
    number of days from study drug initiation to starting another treatment

  • Assess hematologic response based on blood and urine testing using standard criteria [ Time Frame: 3 months ]
    number of patients with complete or partial response

  • Assess organ responses based on standard criteria included in protocol [ Time Frame: 3 months ]
    number of patients with organ response


Estimated Enrollment: 25
Actual Study Start Date: March 20, 2017
Estimated Study Completion Date: August 2020
Estimated Primary Completion Date: August 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Daratumumab
Daratumumab, 16mg/kg body weight in 500mL once weekly for two months, then every 2 weeks for four months, then once each month. (first dose is 8mg/kg body weight in 500mL)
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 Name: Darzalex

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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:

    i. 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

    c. 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02841033

Contacts
Contact: Salli Fennessey 6176386521 sally.fennessey@bmc.org

Locations
United States, Massachusetts
Boston Medical Center Recruiting
Boston, Massachusetts, United States, 02118
Contact: Salli Fennessey, CCRP    617-638-8265    sally.fennessey@bmc.org   
Principal Investigator: Vaishali Sanchorawala, MD         
Sponsors and Collaborators
Vaishali Sanchorawala
Janssen Pharmaceuticals
Investigators
Principal Investigator: Vaishali Sanchorawala, MD Boston Medical Center
  More Information

Additional Information:
Responsible Party: Vaishali Sanchorawala, Principal Investigator, Boston Medical Center
ClinicalTrials.gov Identifier: NCT02841033     History of Changes
Other Study ID Numbers: H-35360
54767414AMY2002 ( Other Identifier: Janssen Pharmaceuticals )
Study First Received: June 14, 2016
Last Updated: March 28, 2017
Individual Participant Data  
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

Additional relevant MeSH terms:
Amyloidosis
Proteostasis Deficiencies
Metabolic Diseases
Daratumumab
Antibodies, Monoclonal
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 22, 2017