Daratumumab and Pomalidomide in Previously Treated Patients With AL Amyloidosis (NCT04895917) | Clinical Trial Compass
TerminatedPhase 2
Daratumumab and Pomalidomide in Previously Treated Patients With AL Amyloidosis
Stopped: low patient enrollment rate
Italy27 participantsStarted 2021-06-23
Plain-language summary
This study aims at establishing a new powerful combination of daratumumab and pomalidomide as rescue treatment for patients with R/R AL amyloidosis.
Who can participate
Age range
18 Years – 99 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Histologic diagnosis of AL amyloidosis;
. Patients should have received at least one line(and no more than 3 lines)with an alkylating agent and/or a PIn and dexamethasone and not be in VGPR or CR at the time of inclusion (patients who did not reach VGPR or patients in VGPR or better but with an hematological relapse can be included);
. Measurable hematologic disease: difference between involved and uninvolved FLC \> 20 mg/L with an abnormal k/l ratio;
. Wash-out period of at least 4 weeks from previous antitumor therapy or any investigational treatment or 5 half-lives from previous antibodies, whichever is longer. Treatment from previous therapy should be in accordance to the local clinical practice in which a 4 weeks period is required for the evaluation of response;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Rate of good quality (i.e. CR+VGPR) hematologic response.
Timeframe: 6 months
Trial details
NCT IDNCT04895917
SponsorFondazione IRCCS Policlinico San Matteo di Pavia
. Adequate bone marrow function prior to 1st drug intake (C1D1), without transfusion or growth factor support within 5 days prior to 1st drug intake, defined as:
. Adequate organ function defined as:
. Female patients who are postmenopausal for at least 1 year before the screening visit, or are surgically sterile, or if they are of childbearing potential, agree to practice effective methods of contraception from the time of signing the informed consent through 30 days after the last dose of study drug, or agree to completely abstain from intercourse (serum pregnancy test has to be performed for all women of childbearing potential at the beginning of each cycle during the study. In addition, a pregnancy test may be done at any time during the study at the discretion of the investigator if a subject miss a period or has unusual menstrual bleeding);
Exclusion criteria
. Presence of non-AL amyloidosis;
. AL amyloidosis with isolated soft tissue involvement;
. Bone marrow plasma cells \>30% and clinically symptomatic multiple myeloma with lytic bone lesions;
. NT-proBNP \>8500 ng/L and hs-troponin I \>100 ng/L (cardiac stage IIIb patients);
. Repetitive ventricular arrhythmias on 24h Holter ECG despite anti-arrhythmic treatment, except if a pacemaker has been implanted;
. Chronic atrial fibrillation with uncontrolled heart rate;
. Supine systolic blood pressure \<100 mmHg;
. Subject is a woman who is pregnant, or breast-feeding, or planning to become pregnant;