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
Status: | Recruiting |
---|---|
Conditions: | Hematology |
Therapuetic Areas: | Hematology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 4/6/2019 |
Start Date: | October 5, 2017 |
End Date: | October 30, 2025 |
Contact: | Study Contact |
Email: | JNJ.CT@sylogent.com |
Phone: | 844-434-4210 |
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
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.
cyclophosphamide, bortezomib and dexamethasone (CyBorD) compared with CyBorD alone in
treatment of newly diagnosed amyloid light chain (AL) amyloidosis participants.
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.
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.
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
We found this trial at
34
sites
Mayo Clinic Mayo Clinic's campus in Arizona provides medical care for thousands of people from...
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Barbara Ann Karmanos Cancer Institute Karmanos is based in southeast Michigan, in midtown Detroit, and...
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1211 Medical Center Dr
Nashville, Tennessee 37232
Nashville, Tennessee 37232
(615) 322-5000
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
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Univ of Rochester Medical Center One of the nation's top academic medical centers, the University...
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Seattle Cancer Care Alliance Seattle Cancer Care Alliance (SCCA) is a cancer treatment center that...
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1365 Clifton Rd NE
Atlanta, Georgia 30322
Atlanta, Georgia 30322
(404) 778-1900
Winship Cancer Institute at Emory University Winship Cancer Institute of Emory University is Georgia
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University of Maryland As a globally-connected university offering a world-class education, the University of Maryland...
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1 Boston Medical Center Place
Boston, Massachusetts 02118
Boston, Massachusetts 02118
617.638.8000
Boston University Medical Center Boston Medical Center is an extraordinary community of health care providers...
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Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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1721 East 19th Ave., Suite #200 & #300
Denver, Colorado 80218
Denver, Colorado 80218
720-754-4800
Colorado Blood Cancer Institute When patients come to the Colorado Blood Cancer Institute, the entire...
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1515 Holcombe Blvd
Houston, Texas 77030
Houston, Texas 77030
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University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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3322 West End Avenue
Nashville, Tennessee 37203
Nashville, Tennessee 37203
(615)329-SCRI (7274)
Sarah Cannon Research Institute Sarah Cannon Research Institute (SCRI) is a global strategic research organization...
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1468 Madison Avenue
New York, New York 10029
New York, New York 10029
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Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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Mayo Clinic Rochester Mayo Clinic is a nonprofit worldwide leader in medical care, research and...
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660 S Euclid Ave
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Saint Louis, Missouri 63110
(314) 362-5000
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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Stanford University Stanford University, located between San Francisco and San Jose in the heart of...
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1 Medical Center Boulevard
Winston-Salem, North Carolina 27157
Winston-Salem, North Carolina 27157
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