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New treatment option for AL Amyloidosis
Official title Elranatamab in Patients With Relapsed or Refractory AL Amyloidosis
ClinicalTrials.gov ID: NCT06569147
What this study is testing
What is Elranatamab?
Elranatamab is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for al amyloidosis.
Also referred to as Elrexfio.
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
- This study will evaluate the safety, tolerability and efficacy of elranatamab in patients with relapsed or refractory AL amyloidosis.
- 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
- Previously diagnosed with AL amyloidosis based on IMWG criteria who have relapsed or refractory disease after treatment with at least one prior line...
- Participants must have progression of light chain disease, defined as dFLC \>20mg/L.
- For Phase 2 only, measurable hematologic disease, satisfying one of the following criteria: Difference between involved and uninvolved free light...
- Age ≥ 18 years
- ECOG performance status ≤2 or Karnofsky ≥60%
You likely can't join if
- Prior BCMA-targeting bispecific antibodies or BCMA-targeting CAR-T therapy.
- Participants refractory to belantamab mafodotin OR participants that have received belantamab as the immediate past line of therapy.
- Participants who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \> Grade 1) with the...
- Participants who are receiving any other investigational agents for this condition.
- Participants with Stage IIIB Amyloidosis as defined by the 2004 Mayo Clinic Criteria (see above).
- History of allergic reactions to elranatamab.
See the full eligibility criteria
- Previously diagnosed with AL amyloidosis based on IMWG criteria who have relapsed or refractory disease after treatment with at least one prior line of therapy (minimum 2 cycles).
- Participants must have progression of light chain disease, defined as dFLC \>20mg/L.
- For Phase 2 only, measurable hematologic disease, satisfying one of the following criteria: Difference between involved and uninvolved free light chain (FLC) over 40 mg/L; Abnormal level of FLC with an abnormal κ/λ...
- Age ≥ 18 years
- ECOG performance status ≤2 or Karnofsky ≥60%
- Participants must meet the following organ and marrow function as defined below: Absolute leukocyte count ≥3,000/mcL , Absolute neutrophil count ≥1,000/mcL, Absolute platelet count ≥75,000/mcL , Direct bilirubin ≤1.5 ×...
- Participants who received belantamab mafodotin are eligible if discontinued due to intolerance or adverse event.
- For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.
- Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. For participants with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV...
- AL Amyloidosis Cardiac stage I, II or IIIa disease based on the 2013 European Modification of the 2004 Standard Mayo Clinic Staging in participants with advanced cardiac involvement (Dispenzieri et al., 2004; Wechalekar...
- The effects of elranatamab on the developing human fetus are unknown. Based on the mechanism of action, elranatamab may cause fetal harm when administered to a pregnant woman and therefore should not be used during...
- Ability to understand and the willingness to sign a written informed consent document.
- Willingness to undergo study procedures, including bone marrow biopsies as detailed in the schedule of events.
- Participants should have received prior treatment with Daratumumab + CyBorD.
- Prior BCMA-targeting bispecific antibodies or BCMA-targeting CAR-T therapy.
- Participants refractory to belantamab mafodotin OR participants that have received belantamab as the immediate past line of therapy.
- Participants who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \> Grade 1) with the exception of alopecia.
- Participants who are receiving any other investigational agents for this condition.
- Participants with Stage IIIB Amyloidosis as defined by the 2004 Mayo Clinic Criteria (see above).
- History of allergic reactions to elranatamab.
- Participants with an active malignancy (including lymphoma) with the following exceptions: adequately treated basal cell carcinoma, squamous cell carcinoma, or in situ cervical cancer; adequately treated stage I cancer...
- Women who are pregnant, breastfeeding, or planning to become pregnant while enrolled in this study or 4 months following discontinuation of elranatamab, whichever is longer. Pregnant women are excluded from this study...
- Have any other medical, social or psychological factors that could affect the participant's safety or ability to consent personally or comply with study procedures.
- Participants meeting criteria for active MM based on presence of CRAB criteria (a ratio of involved versus uninvolved FLC over 100 is allowed in the absence of CRAB criteria).
- Participants with active clinically significant autoimmune diseases.
- Participants seropositive for the human immunodeficiency virus (HIV).
- Severe, uncontrolled orthostatic hypotension resulting in syncopal/pre-syncopal events despite optimized medical management (e.g., midodrine, pyridostigmine) and in the absence of volume depletion.
- Plan for autologous stem cell transplant during the first 6 months of protocol therapy.
- History of acute coronary syndrome or uncontrolled ventricular arrhythmias within 3 months prior to screening.
- Evidence of LV systolic dysfunction as defined by LVEF is \< 30% by echocardiogram at Screening per site cardiology interpretation.
- Presence of severe valvular stenosis (e.g., aortic or mitral stenosis with a valve area \< 1.0 cm2) or severe congenital heart disease.
- Have history of sustained ventricular tachycardia or aborted ventricular fibrillation or a history of atrioventricular nodal or sinoatrial nodal dysfunction if a permanent pacemaker (PPM) or implantable...
- QT corrected by Fridericia (QTcF) is \> 550 msec on Screening ECG unless they have a PPM/ICD implanted.
- Screening EKG showing acute myocardial ischemia or active conduction system abnormalities with the exception of any of the following: First degree atrioventricular block; Second degree atrioventricular block Type 1...
- Major surgery that required general anesthesia within 4 weeks of randomization or is planning major surgery during the study.
- NYHA class IV symptoms or participants with acute decompensation of congestive heart failure.
- Transplant eligible participants who have not undergone transplant are not eligible.
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
Compensation & support
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 Boston, Massachusetts, 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.