Trial Search Results
A Study to Evaluate the Safety and Tolerability of CAEL-101 in Patients With AL Amyloidosis
The purpose of the Part A of the study is to determine if the studydrug CAEL-101 is well-tolerated when given at different amounts topeople with AL amyloidosis who are also receiving chemotherapy(chemical agents to treat AL amyloidosis).The purpose of study Part B is to determine if CAEL-101 is well toleratedwhen given to people with AL amyloidosis who are also receiving a chemotherapy treatment that includes daratumumab.
Stanford is currently accepting patients for this trial.
- Drug: CAEL-101
- Drug: cyclophosphamide, bortezomib, and Dexamethasone (CyBorD)
- Drug: Daratumumab
Each patient must meet the following criteria to be enrolled in this study.
1. Provide written informed consent and be willing and able to comply with all study
2. Adult, 18 years and older
3. Minimum life expectancy of 6 months
4. AL amyloidosis Mayo stage I, II, or IIIa at the time of Screening
5. 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
6. a. For Part A, currently on and continuing OR planned to start concurrent chemotherapy
with CyBorD administered weekly as SoC.
b. For Part B, currently on and continuing OR planned to start concurrent chemotherapy
with CyBorD and daratumumab administered as SoC.
7. Adequate bone marrow reserve and hepatic function as demonstrated by:
8. Women of childbearing potential (WOCBP) must have a negative serum pregnancy test
during Screening and must agree to use effective physician-approved contraception from
Screening to 90 days following the last study drug administration
9. Men must be surgically sterile or must agree to use effective physician-approved
contraception from Screening to 90 days following the last study drug administration
Patients who meet any of the following criteria will not be permitted entry to the study.
1. Any form of secondary, hereditary, senile, localized, dialysis-related or leukocyte
chemotactic factor 2-related (ALECT2) amyloidosis
2. Meets the International Myeloma Working Group (IMWG) definition of multiple myeloma.
3. Supine systolic blood pressure < 90 mmHg or symptomatic orthostatic hypotension,
defined as a decrease in systolic blood pressure upon standing of > 20 mmHg despite
medical management (e.g., midodrine, fludrocortisones) in the absence of volume
4. Taking prednisone or its equivalent > 10 mg/day
5. Receiving dialysis
6. Planned stem cell transplant during the first 6 months of protocol therapy.
7. Myocardial infarction, uncontrolled angina, severe uncontrolled ventricular
arrhythmias, or percutaneous cardiac intervention with recent stent, coronary artery
bypass grafting or major cerebrovascular accident within 6 months prior to screening
8. Left ventricular ejection fraction (LVEF) < 45 percent by echocardiogram or multigated
acquisition scan (MUGA) within the last 6 months
9. Severe valvular stenosis (e.g. aortic or mitral stenosis with a valve area <1.0 cm^2)
or severe congenital heart disease
10. History of sustained ventricular tachycardia or aborted ventricular fibrillation or
with a history of atrioventricular nodal or sinoatrial 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)
11. QTcF > 500 msec. Participants who have a pacemaker may be included regardless of
calculated QTc interval.
12. Evidence of acute ischemia or active conduction system abnormalities with the
exception of any of the following:
1. First degree AV-block
2. Second degree AV-block Type 1 (Mobitz Type 1/Wenckebach type)
3. Right or left bundle branch block
4. Atrial fibrillation with a controlled ventricular rate (uncontrolled [i.e., >110
bpm] ventricular rate is not allowed [determined by an average of three beats in
Lead II or representative beats if Lead II is not representative of the overall
13. Major surgery within 4 weeks of first dose or planned major surgery during the study.
Patients with surgical procedures conducted under local anesthesia may participate.
14. POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly,
endocrinopathy, monoclonal protein [M-protein] and skin changes)
15. Active malignancy (including lymphoma) with the exception of any of the following:
1. Adequately treated basal cell carcinoma, squamous cell carcinoma, or in situ
2. Adequately treated Stage I cancer from which the patient is currently in
remission and has been in remission for > 2 years
3. Low-risk prostate cancer with Gleason score < 7 and prostate-specific antigen <
16. Patients receiving an investigational drug/device in another clinical investigational
study within 60 days before Screening
17. Nursing mothers will not be permitted entry into the study.
Ages Eligible for Study
18 Years - N/A
Genders Eligible for Study