EUCTR2020-004001-32-GRActive, not recruitingPhase 1
A phase 2 study of Belantamab Mafodotin in patients with relapsed or refractory AL amyloidosis
European Myeloma Network – EM0 sites36 target enrollmentStarted: December 4, 2020Last updated:
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 36
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •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.
- •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.
- •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 study, 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 study
- •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
- •study 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
- •Nonchildbearing potential is defined as follows (by other than medical
- •a.=45 years of age and has not had menses for >1
- •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
- •c.Post-hysterectomy, post-bilateral oophorectomy, or post-tubal
- •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
- +3 more not shown
Exclusion Criteria
- •1.Presence of non-AL amyloidosis.
- •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.
- •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
- •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.
- •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.
- •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 study.
- •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 study drug.
- •14.Plasmapheresis within seven days prior to the first dose of the study
- •15.Treatment with a monoclonal antibody within 30 days prior to the
- •first dose of the study treatment. Serious conditions unrelated to AL,
- •such as SARS-CoV-2, may be permitted but need to be discussed with
- •the medical doctor and study-site personnel.
- +6 more not shown
Investigators
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