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A Study to Evaluate the Efficacy and Safety of Daratumumab in Combination W... | Recruiting
A Study to Evaluate the Efficacy an... | Recruiting
A Study to Evaluate the Efficacy and Safety of Daratumumab in Combination With Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared to CyBorD Alone in Newly Diagnosed Systemic Amyloid Light-chain (AL) Amyloidosis

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Medical Conditions
  • Amyloidosis
Primary Contact Details
Recruitment Status
Recruiting
Trial source and source ID number
NCT03201965
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Summary
The purpose of this study is to evaluate the efficacy and safety of daratumumab plus cyclophosphamide, bortezomib and dexamethasone (CyBorD) compared with CyBorD alone in treatment of newly diagnosed amyloid light chain (AL) amyloidosis participants.
Research Details
  • Participant involved in study for approx. 8 years duration includes Screening Phase (complete clinical evaluation will be done), Treatment Phase (monitoring of adverse events (AEs), laboratory abnormalities and clinical response), Post-Treatment Observation Phase (disease evaluations will be done) and a Long-term Follow-up Phase (Subsequent anticancer treatment, response to subsequent treatment, date of progression and survival status will be obtained every 16 weeks).The primary hypothesis is that daratumumab in combination with CyBorD will improve the overall complete hematological response rate compared to CyBorD alone in AL amyloidosis participants. Safety will be assessed by AEs, laboratory test results, electrocardiogram, vital sign measurements, physical examination, and Eastern Cooperative Oncology Group (ECOG) performance status.
Phase
Phase 3
Study Design
Sorry, this information is not available
Study Type
Interventional
Intervention
Drug : Cyclophosphamide, Drug : Bortezomib, Drug : Dexamethasone, 40 mg, Drug : Daratumumab

Study Arm Groups : CyBorD alone (cyclophosphamide/bortezomib/dexamethasone), CyBorD plus Daratumumab, CyBorD alone (cyclophosphamide/bortezomib/dexamethasone), CyBorD plus Daratumumab, CyBorD alone (cyclophosphamide/bortezomib/dexamethasone), CyBorD plus Daratumumab, CyBorD plus Daratumumab

Intervention Type
See Interventions above
Primary Outcome Measures
    Percentage of Participants With Overall Complete Hematologic Response; Approximately 3 years
Secondary Outcome Measures
    Major Organ Deterioration Progression-Free Survival (MOD-PFS); Approximately 5 years; Progression-Free Survival (PFS); Approximately 5 years; Organ Response Rate (OrRR); Approximately 5 years; Overall Survival (OS); Approximately 8 years; Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-C30 Fatigue Scale Score; Baseline, up to end of study (approximately 5 years); Change From Baseline in the 36-Item Short Form Survey version 2 (SF-36v2) Mental Component Summary (MCS); Baseline, up to end of study (approximately 5 years); Change From Baseline in the EORTC QLQ-C30 Global Health Status Scale Score; Baseline, up to end of study (approximately 5 years); Time to Next Treatment (TNT); Approximately 5 years; Hematologic Very Good Partial Response or Better Rate; Approximately 3 years; Time to Complete Hematologic Response; Approximately 3 years; Time to Hematologic Very Good Partial Response (VGPR) or Better Response; Approximately 3 years; Duration of Complete Hematologic Response; Approximately 5 years; Duration of Hematologic Very Good Partial Response (VGPR) or Better Response; Approximately 5 years; Time to Organ Response; Approximately 5 years; Duration of Organ Response; Approximately 5 years
Publication(s)
Sorry, this information is not available
Result Reports
Check availability of results on the Clinicaltrials.gov website
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Gender
All
Age Range
18 Years - N/A
Who Can Participate
Patients
Number of Participants
370
Participant Inclusion Criteria
    Inclusion Criteria:

    - Histopathological diagnosis of amyloidosis based on detection by immunohistochemistry and polarizing light microscopy of green bi-refringent material in congo red stained tissue specimens (in an organ other than bone marrow) or characteristic electron microscopy appearance

    - Measurable disease of amyloid light-chain (AL) amyloidosis as defined by at least one of the following:

    1. serum monoclonal (M)-protein greater than or equal (>=) 0.5 grams/deciliter (g/dL) by protein electrophoresis (routine serum protein electrophoresis and immunofixation [IFE] performed at a central laboratory)

    2. serum free light chain greater than or equal to (>=) 50 milligram/Liter (mg/L) with an abnormal kappa:lambda ratio or the difference between involved and uninvolved free light chains (dFLC) >= 50 mg/L

    - One or more organs impacted by AL amyloidosis according to consensus guidelines

    - Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0, 1 or 2

    Exclusion Criteria:

    - Prior therapy for AL amyloidosis or multiple myeloma including medications that target CD38, with the exception of 160 mg dexamethasone (or equivalent corticosteroid) maximum exposure prior to randomization

    - Previous or current diagnosis of symptomatic multiple myeloma, including the presence of lytic bone disease, plasmacytomas, >= 60 percent (%) plasma cells in the bone marrow, or hypercalcemia

    - Evidence of significant cardiovascular conditions as specified below:

    1. NT-ProBNP > 8500 nanogram per liter (ng/L)

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

    3. Heart failure that in the opinion of the investigator is on the basis of ischemic heart disease (eg, prior myocardial infarction with documented history of cardiac enzyme elevation and electrocardiogram [ECG] changes) or uncorrected valvular disease and not primarily due to AL amyloid cardiomyopathy

    4. Inpatient admission to a hospital for unstable angina or myocardial infarction within the last 6 months prior to first dose or percutaneous cardiac intervention with recent stent within 6 months or coronary artery bypass grafting within 6 months

    5. For participants with congestive heart failure, cardiovascular-related hospitalizations within 4 weeks prior to randomization

    6. Participants with a history of sustained ventricular tachycardia or aborted ventricular fibrillation or with a history of atrioventricular (AV) nodal or sinoatrial (SA) nodal dysfunction for which a pacemaker/implantable cardioverter-defibrillators [ICD] is indicated but not placed (participants who do have a pacemaker/ICD are allowed on study)

    7. Screening 12-lead ECG showing a baseline QT interval as corrected by Fridericia's formula (QTcF) > 500 milliseconds (msec). Participants who have a pacemaker may be included regardless of calculated QTc interval

    8. Supine systolic blood pressure < 90 millimeter of mercury (mmHg), or symptomatic orthostatic hypotension, defined as a decrease in systolic blood pressure upon standing of > 20 mmHg despite medical management (eg, midodrine, fludrocortisones) in the absence of volume depletion

    - Planned stem cell transplant during the first 6 cycles of protocol therapy are excluded. Stem cell collection during the first 6 cycles of protocol therapy is permitted

    - Known to be seropositive for human immunodeficiency virus (HIV)

    - Any one of the following:

    1. Seropositive for hepatitis B (defined by a positive test for hepatitis B surface antigen [HBsAg]). Participants with resolved infection (ie, participants who are HBsAg negative but positive for antibodies to hepatitis B core antigen [anti-HBc] and/or antibodies to hepatitis B surface antigen [anti-HBs]) must be screened using real-time polymerase chain reaction (PCR) measurement of hepatitis B virus (HBV) deoxyribonucleic acid (DNA) levels. Those who are PCR positive will be excluded

    2. Known to be seropositive for hepatitis C (except in the setting of a sustained virologic response [SVR], defined as aviremia at least 12 weeks after completion of antiviral therapy)

    - Grade 2 sensory or Grade 1 painful peripheral neuropathy
Participant Exclusion Criteria
This is in the inclusion criteria above
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Trial Location(s)
Birmingham
B15 2TH
London
NW1 2PG
Trial Contact(s)
Primary Trial Contact
Study Contact
844-434-4210
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
Australia, Belgium, Brazil, Canada, China, Denmark, France, Germany, Greece, Hungary, Israel, Italy, Japan, Korea, Republic of, Mexico, Netherlands, Poland, Spain, Sweden, Turkey, United Kingdom, United States
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Scientific Title
A Randomized Phase 3 Study to Evaluate the Efficacy and Safety of Daratumumab in Combination With Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared to CyBorD Alone in Newly Diagnosed Systemic AL Amyloidosis
EudraCT Number
Not available for this trial
Funder(s)
    Sorry, this information is not available
Other Study ID Numbers
CR108193
Sponsor(s)
Janssen Research & Development, LLC
Key Dates

Recruitment Start Date

Oct 2017

Recruitment End Date

Feb 2020

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date added to source

27 Jun 2017

Date updated in source

04 Apr 2019