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Belantamab Mafodotin in patients with relapsed or refractory AL amyloidosis
EU CTIS ID: 2024-513075-40-00
What this study is testing
To evaluate the efficacy of blmf in patients with relapsed or refractory AL amyloidosis.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1.Diagnosis of AL amyloidosis, confirmed by histology and typed with immunohistochemistry, immunoelectron microscopy or mass spectrometry, or if not available, for patients with biopsy confirmed amyloidosis and cardiac involvement alone, if they also have a negative PYP- or DPD-Tc99m bone scan.
- 10.Written informed consent in accordance with local and institutional guidelines.
- 11.Female patients: contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. A female patient is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: a.She is not of childbearing potential (WOCBP) OR b.She is a WOCBP and using, during the intervention period and for at least 4 months after the last dose of the trial, a contraceptive method that is highly effective (failure rate <1% per year), preferably with low user dependency (as described in Appendix 3). Patient agrees not to donate eggs (ova, oocytes) for the purpose of reproduction during this period. The investigator should evaluate the effectiveness of the contraceptive method in relationship to the first dose of trial intervention. A WOCBP must have a negative highly sensitive serum-pregnancy test (as required by local regulations) 72 hours before the first dose of the trial intervention. The investigator is responsible for reviewing the medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with a nearly undetected pregnancy. Nonchildbearing potential is defined as follows (by other than medical reasons): a.≥45 years of age and has not had menses for >1 year b.Patients who have been amenorrhoeic for <2 years without a history of hysterectomy and oophorectomy must have a follicle stimulating hormone value in the postmenopausal range after screening evaluation c.Post-hysterectomy, post-bilateral oophorectomy, or post-tubal ligation. Documented hysterectomy or oophorectomy must be confirmed with medical records of the actual procedure or confirmed by an ultrasound. Tubal ligation must be confirmed with medical records of the actual procedure.
- 12. Male patients: contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Male patients are eligible to participate if they agree to the following during the intervention period and for 6 months after the last dose of trial treatment to allow for clearance of any altered sperm: a.Refrain from donating sperm PLUS, either: b.Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent. OR c.Must agree to use contraception/barrier as detailed below: Agree to use a male condom, even if they have undergone a successful vasectomy, and female partner agrees to use an additional highly effective contraceptive method with a failure rate of <1% per year as when having sexual intercourse with a woman of childbearing potential who is not pregnant.
- 13. All toxicities related to previous treatment (defined by National Cancer Institute- Common Toxicity Criteria for Adverse Events [NCICTCAE], version 5, corneal toxicities are defined according to the Keratopathy Visual Activity [KVA] scale), must be ≤ Grade 1 at the time of enrolment except for alopecia.
- 14. Patient must be able to understand the trial procedures and agree to participate in the trial by providing written informed consent.
You likely can't join if
- 1.Presence of non-AL amyloidosis.
- 10.Active renal condition (infection, requirement for dialysis or any other condition that could affect the patient's safety) unrelated to AL amyloidosis. Patients with isolated proteinuria resulting from AL are eligible, provided they fulfil other inclusion criteria.
- 11.Patient must not use contact lenses while participating in this trial.
- 12.Patient must not be simultaneously enrolled in any interventional clinical trial.
- 13.Use of an investigational drug or approved systemic anti-myeloma therapy (including systemic steroids) within 14 days or five half-lives, whichever is shorter, prior to the first dose of trial drug.
- 14.Plasmapheresis within seven days prior to the first dose of the trial treatment.
See the full eligibility criteria
Who can join
- 1.Diagnosis of AL amyloidosis, confirmed by histology and typed with immunohistochemistry, immunoelectron microscopy or mass spectrometry, or if not available, for patients with biopsy confirmed amyloidosis and cardiac involvement alone, if they also have a negative PYP- or DPD-Tc99m bone scan.
- 10.Written informed consent in accordance with local and institutional guidelines.
- 11.Female patients: contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. A female patient is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: a.She is not of childbearing potential (WOCBP) OR b.She is a WOCBP and using, during the intervention period and for at least 4 months after the last dose of the trial, a contraceptive method that is highly effective (failure rate <1% per year), preferably with low user dependency (as described in Appendix 3). Patient agrees not to donate eggs (ova, oocytes) for the purpose of reproduction during this period. The investigator should evaluate the effectiveness of the contraceptive method in relationship to the first dose of trial intervention. A WOCBP must have a negative highly sensitive serum-pregnancy test (as required by local regulations) 72 hours before the first dose of the trial intervention. The investigator is responsible for reviewing the medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with a nearly undetected pregnancy. Nonchildbearing potential is defined as follows (by other than medical reasons): a.≥45 years of age and has not had menses for >1 year b.Patients who have been amenorrhoeic for <2 years without a history of hysterectomy and oophorectomy must have a follicle stimulating hormone value in the postmenopausal range after screening evaluation c.Post-hysterectomy, post-bilateral oophorectomy, or post-tubal ligation. Documented hysterectomy or oophorectomy must be confirmed with medical records of the actual procedure or confirmed by an ultrasound. Tubal ligation must be confirmed with medical records of the actual procedure.
- 12. Male patients: contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Male patients are eligible to participate if they agree to the following during the intervention period and for 6 months after the last dose of trial treatment to allow for clearance of any altered sperm: a.Refrain from donating sperm PLUS, either: b.Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent. OR c.Must agree to use contraception/barrier as detailed below: Agree to use a male condom, even if they have undergone a successful vasectomy, and female partner agrees to use an additional highly effective contraceptive method with a failure rate of <1% per year as when having sexual intercourse with a woman of childbearing potential who is not pregnant.
- 13. All toxicities related to previous treatment (defined by National Cancer Institute- Common Toxicity Criteria for Adverse Events [NCICTCAE], version 5, corneal toxicities are defined according to the Keratopathy Visual Activity [KVA] scale), must be ≤ Grade 1 at the time of enrolment except for alopecia.
- 14. Patient must be able to understand the trial procedures and agree to participate in the trial by providing written informed consent.
- 2.Patients must have had at least two cycles of therapy directed against plasma cell clone. However, patients that have received high dose therapy with melphalan as their only therapy are also eligible.
- 3.Patients must be 18 years of age or above
- 4.ECOG performance status 0, 1 or 2.
- 5.Mayo stage 1 or Mayo stage 2 or Mayo stage 3A1-3 defined as both cTnT < 0.035 ng/mL (or in place of cTnT the cTnI < 0.10 ng/mL or high sensitivity Troponin T < 54 ng/L) AND simultaneous NT-proBNP ≤ 332 ng/L, OR EITHER above threshold, or BOTH above threshold but with NTproBNP < 8500 ng/L (stage 3A disease)
- 6.Supine systolic blood pressure ≥ 90 mmHg.
- 7.Measurable disease defined by at least one of the following: a.serum free light chain (FLC) ≥2.0 mg/dL (20 mg/L) with an abnormal kappa:lambda ratio or the difference between involved and uninvolved free light chains (dFLC) ≥2mg/dL (20 mg/L). b.presence of a monoclonal spike that is ≥0.5 g/dl.
- 8.Symptomatic organ involvement (heart, kidney, liver/GI tract, peripheral nervous system).
- 9. Patients must have adequate organ function.
What rules you out
- 1.Presence of non-AL amyloidosis.
- 10.Active renal condition (infection, requirement for dialysis or any other condition that could affect the patient's safety) unrelated to AL amyloidosis. Patients with isolated proteinuria resulting from AL are eligible, provided they fulfil other inclusion criteria.
- 11.Patient must not use contact lenses while participating in this trial.
- 12.Patient must not be simultaneously enrolled in any interventional clinical trial.
- 13.Use of an investigational drug or approved systemic anti-myeloma therapy (including systemic steroids) within 14 days or five half-lives, whichever is shorter, prior to the first dose of trial drug.
- 14.Plasmapheresis within seven days prior to the first dose of the trial treatment.
- 15.Treatment with a monoclonal antibody within 30 days prior to the first dose of the trial treatment. Serious conditions unrelated to AL, such as SARS-CoV-2, may be permitted but need to be discussed with the medical doctor and trial-site personnel.
- 16.Major surgery ≤ 4 weeks prior to initiating trial treatment.
- 17.Evidence of active mucosal or internal bleeding
- 18.Known immediate or delayed hypersensitivity reaction or idiosyncratic reactions to blmf or drugs chemically related to blmf, or any of the components of the trial treatment.
- 19.Active infection requiring treatment.
- 2.Presence of lytic bone lesions or active myeloma with hypercalcemia, cast nephropathy, anemia due to marrow infiltration or extramedullary disease > 60% plasma cells in bone marrow.
- 20.Known HIV infection (defined as positive testing for human immunodeficiency virus [HIV] antibodies).
- 21.Positive test for hepatitis B surface antigen (HBsAg), or hepatitis B core antibody (HBcAb) at screening or within 3 months prior to the first dose of trial treatment.
- 22.Positive test for hepatitis C antibody hepatitis C RNA at screening or within 3 months prior to the first dose of the trial treatment.
- 23.Invasive malignancies other than the disease under trial, unless the second malignancy has been medically stable for at least 2 years and, in the opinion of the principal investigators, will not affect the evaluation of the effects of the clinical trial treatments of the currently targeted malignancy. Patients with curatively treated non-melanoma skin cancer may be enrolled without a 2-year restriction.
- 24.Any serious and/or unstable pre-existing medical, psychiatric disorder, or other conditions (including lab abnormalities) that could interfere with the patient's safety, informed consent or compliance to the trial procedures.
- 25.Patients must not be pregnant or breast-feeding.
- 26.Participant must not have received a live or live-attenuated vaccine within 30 days prior to first dose of belantamab mafodotin.
- 3.Previous exposure to anti-BCMA agents.
- 4.Cardiac stage IIIB disease: both cTnT > 0.035 ng/mL (or in place of cTnT the cTnI > 0.10 ng/mL or high sensitivity Troponin T > 54 ng/L) AND simultaneous NT-proBNP >8500 ng/L.
- 5.Known repetitive ventricular arrhythmias on 24h Holter Electrocardiograms (ECG) despite anti-arrhythmic treatment. Patient must not have evidence of cardiovascular risk including any of the following: •Evidence of current clinically significant uncontrolled arrhythmias, including clinically significant ECG abnormalities such as 2nd degree (Mobitz Type II) or 3rd degree atrioventricular (AV) block. •History of myocardial infarction, acute coronary syndromes (including unstable or uncontrolled angina), coronary angioplasty, or stenting or bypass grafting within three (3) months of screening. •Class III or IV heart failure as defined by the New York Heart Association functional classification system (NYHA, 1994). •Severe uncontrolled ventricular arrhythmias, sick sinus syndrome, electrocardiographic evidence of acute ischemia or Grade 3 conduction system abnormalities (unless patient has a pacemaker). •Uncontrolled hypertension or hypotension (i.e., supine SBP< 90 mmHg despite supportive therapy with midodrine)
- 6.Significant neuropathy (Grades 3–4, or Grade 2 with pain) within 14 days prior to Cycle 1 Day 1.
- 7.Pleural effusions requiring thoracentesis or ascites requiring paracentesis within 14 days prior to Cycle 1 Day 1.
- 8.Ongoing corneal epithelial disease except mild changes in corneal epithelium (mild punctate keratopathy).
- 9.Current unstable liver or biliary disease defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia (except due to related nephrotic syndrome), esophageal or gastric varices, persistent jaundice, or cirrhosis. Note: Stable non-cirrhotic chronic liver disease (including Gilbert's syndrome or asymptomatic gallstones) or hepatobiliary involvement of malignancy is acceptable if otherwise meets entry criteria.
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.