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New treatment option for AL Amyloidosis
Official title Phase 1/2a Study of Belantamab Mafodotin in Relapsed or Refractory AL Amyloidosis
ClinicalTrials.gov ID: NCT05145816
What this study is testing
What is Belantamab mafodotin 2.5 mg/kg (8 weeks)?
Belantamab mafodotin 2.5 mg/kg (8 weeks) is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for al amyloidosis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this study is to test the safety of drug, Belantamab Mafodotin, and see what effects (good and bad) it has on people who take it and have amyloidosis, and to determine the most effective dose of the drug. The study will have 2 phases (parts).
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Participants medically diagnosed with relapsed or refractory Amyloid Light Chain Amyloidosis (AL amyloidosis) with one or more line of treatment as...
- Must have received a proteosome inhibitor, alkylator and anti-cluster of differentiation 38 (CD38) antibody (e.g., daratumumab - for patients who...
- Failed treatment and/or intolerant/ineligible for above agents NOTE: Patients who fail to achieve Partial Hematological Response or better after 2...
- Participant must be over 18 years of age inclusive, at the time of signing the informed consent.
- Participant and Disease Characteristics: Patient must have primary systemic AL amyloidosis, histologically confirmed at the initial diagnosis before...
You likely can't join if
- Patients previously treated for active symptomatic multiple myeloma.
- Any corneal disease except for mild epithelial punctate keratopathy.
- Patients with known immediate or delayed hypersensitivity reaction or idiosyncratic reactions to belantamab mafodotin or drugs chemically related to...
- Patients eligible for autologous stem cell transplantation (ASCT).
- Evidence of significant cardiovascular condition as specified below:
- N-terminal-prohormone of brain natriuretic peptide (NT-proBNP) ≥ 8500ng/L within 14 days of registration.
See the full eligibility criteria
Who can join
- Participants medically diagnosed with relapsed or refractory Amyloid Light Chain Amyloidosis (AL amyloidosis) with one or more line of treatment as below:
- Must have received a proteosome inhibitor, alkylator and anti-cluster of differentiation 38 (CD38) antibody (e.g., daratumumab - for patients who were eligible to receive in newly diagnosed AL Amyloidosis) and...
- Failed treatment and/or intolerant/ineligible for above agents NOTE: Patients who fail to achieve Partial Hematological Response or better after 2 cycles of induction therapy for newly diagnosed AL Amyloidosis are also...
- Participant must be over 18 years of age inclusive, at the time of signing the informed consent.
- Participant and Disease Characteristics: Patient must have primary systemic AL amyloidosis, histologically confirmed at the initial diagnosis before initiation of 1st-line treatment by positive Congo red stain with...
- Patient must have measurable disease within 28 days prior to registration; serum quantitative immunoglobulins (immunoglobulin G (IgG), immunoglobulin A (IgA), and immunoglobulin M (IgM), serum free kappa and lambda, and...
- Measurable disease of amyloid light chain amyloidosis as defined by at least One of the following: a. Serum M-protein ≥0.5 g/dL by protein electrophoresis (routine serum protein electrophoresis and immunofixation). b...
- One or more organs impacted by AL Amyloidosis according to consensus guidelines below per National Comprehensive Cancer Network (NCCN)Guidelines Version 1.2016: a. Cardiac Involvement i. Mean left ventricular wall...
- Patients must have completed other systemic therapy or investigational drug ≥ 28 days or five half-lives prior to registration, surgery (other than biopsies) ≥ 28 days prior to registration, and any autologous stem cell...
- Patients must have a complete medical history and physical exam within 14 days prior to registration.
- New York Heart Association (NYHA) Class 1 - 3a which has been clinically stable for 56 days before registration
- Eastern Cooperative Oncology Group (ECOG) performance score 0, 1 or 2
- Left ventricular ejection fraction (LVEF) by echocardiogram (ECHO) \> 35% within 28 days prior to registration.
- Adequate organ system functions within 14 days of registration as defined by the laboratory assessments below: a) Hematologic i) Absolute neutrophil count (ANC): ≥1.0 × 10(9)/ L \ ii) Hemoglobin: ≥8.0 g/dL \ iii)...
- Females of childbearing potential: These participants must have a negative baseline pregnancy test using serum or urine within 14 days prior to starting therapy and a confirmatory negative serum pregnancy test with a...
- Is a woman of child bearing potential (WOCBP) and using a contraceptive method that is highly effective (with a failure rate of \<1% per year), preferably with low user dependency (as described in Appendix 9), during...
- A WOCBP must have a negative serum pregnancy test (as required by local regulations) within 72 hours before the first dose of study intervention.
- The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with a nearly undetected pregnancy.
- Non-childbearing potential is defined as follows (by other than medical reasons): i. ≥45 years of age and has not had menses for \>1 year. ii. Patients who have been amenorrhoeic for \<2 years without history of a...
- Refrain from donating sperm Plus, either:
- 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
- agree to use a barrier method of birth control (e.g., male condom), even if they have undergone a successful vasectomy, and female partner to use an additional highly effective contraceptive method with a failure rate...
- Hepatitis B surface antigen (HBsAg)-negative, anti-Hemoglobin C (HBc)-positive patients are at lower risk of HBV reactivation compared with HBsAg-positive patients, risk of HBV reactivation should be considered in all...
- Patients with chronic HBV infection with active disease who meet the criteria for anti HBV therapy should be on a suppressive antiviral therapy prior to initiation of cancer therapy.
- Patients actively on treatment for HCV should have HCV below the limit of quantification before initiation of anti-cancer therapy.
- Patients who are HCV antibody (Ab) positive but HCV Ribonucleic Acid (RNA) negative due to prior treatment or natural resolution of infection are eligible.
What rules you out
- Patients previously treated for active symptomatic multiple myeloma.
- Any corneal disease except for mild epithelial punctate keratopathy.
- Patients with known immediate or delayed hypersensitivity reaction or idiosyncratic reactions to belantamab mafodotin or drugs chemically related to belantamab mafodotin, or any of the components of the study treatment.
- Patients eligible for autologous stem cell transplantation (ASCT).
- Evidence of significant cardiovascular condition as specified below:
- N-terminal-prohormone of brain natriuretic peptide (NT-proBNP) ≥ 8500ng/L within 14 days of registration.
- New York Heart Association (NYHA) classification IIIB (3b) through IV (4) heart failure
- Heart failure that in the opinion of the investigator is on the basis of ischemic heart disease (e.g., prior myocardial infarction with documented history of cardiac enzyme elevation and electrocardiogram (ECG) changes)...
- Unstable heart failure defined as emergency hospitalization for worsening, or decompensated heart failure, or syncopal episode within 1 month of screening
- people with a history of sustained ventricular tachycardia or aborted ventricular fibrillation or with a history of atrioventricular nodal or sinoatrial (SA) nodal dysfunction for which a pacemaker/implantable...
- Interval from the Q wave on the ECG to point T using Fredericia's formula (QTcF) \> 500 msec. people who have a pacemaker may be included regardless of calculated QTc interval
- Symptomatic, clinically significant autonomic neuropathy which the Investigator feels will preclude administration of study treatment
- Acute coronary syndrome, or any form of coronary revascularization procedure including coronary artery bypass grafting (CABG), within 6 months of screening
- Prior solid organ transplant, or anticipated to undergo solid organ transplantation, or requiring left ventricular assist device (LVAD) implantation, during the course of the study
- Stroke within 6 months of screening, or transient ischemic attack (TIA) within 3 months of screening
- 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 angina), coronary angioplasty, or stenting or bypass grafting within three (3) months of Screening
- Uncontrolled hypertension
- Prior history of malignancy with the exception of the following: adequately treated basal cell or squamous cell skin cancer, curatively treated non-melanoma skin cancer, in situ cervical cancer, adequately treated stage...
- Presence of any comorbid or uncontrolled medical condition (e.g. uncontrolled hypertension) - defined as defined as an average SBP ≥ 160mm Hg or diastolic ≥ 100mm Hg despite optimal treatment) at screening, which in the...
- Unwillingness or inability to follow the procedures outlined in the protocol.
- Received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 4 weeks or five half-lives, whichever is shorter, before Cycle 1 Day 1.
- Participant must not use contact lenses while participating in this study.
- Participant must not have had major surgery ≤ 4 weeks prior to initiating study treatment.
- Participant must not have any evidence of active mucosal or internal bleeding.
- Participant must not have any serious and/or unstable pre-existing medical, psychiatric disorder, or other conditions (including lab abnormalities) that could interfere with participant's safety, obtaining informed...
- Participants must not be pregnant or lactating.
- Participant must not be simultaneously enrolled in any treatment clinical trial.
- Participant must not have an active infection requiring treatment.
- Participant must not have current unstable liver or biliary disease defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice, or cirrhosis...
The study team makes the final eligibility decision.
Where it's taking place
- Nashville, Tennessee, United States
- Dallas, Texas, United States
- Salt Lake City, Utah, United States
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nashville, Tennessee, United States; Dallas, Texas, United States; Salt Lake City, Utah, United States. 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 ClinicalTrials.gov; the study team decides eligibility.