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Amyloid Light-chain AmyloidosisPhase 2NCT07524634

Dose Schedule Study of BCMA Bispecific Antibody, Elranatamab, for Newly Diagnosed Immunoglobulin Light Chain (AL) Amyloidosis

A Phase 2 study testing BCMA bispecific in people with Amyloid Light-chain Amyloidosis, run by Case Comprehensive Cancer Center at 2 sites in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This research study is for people who have newly diagnosed with AL (light chain) amyloidosis and have not yet received any treatment for this condition. The purpose of this study is to evaluate whether elranatamab, a type of immunotherapy drug, can produce deep remissions and organ recovery in people with newly… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Amyloid Light-chain Amyloidosis
What is being tested?
BCMA bispecific
Could I receive a placebo?
No, everyone receives an active treatment
How many people
64 participants
Where
2 sitesUnited States
Study dates
Aug 2026to Jun 2031
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Newly diagnosed Immunoglobulin Light Chain (AL) amyloidosis who have not received any prior therapy.
  • Participants must have a tissue biopsy demonstrating Congo red positivity with characteristic birefringence on polarized microscopy and immunohistochemistry or mass spectrometry confirming light chain type.
  • Participants must not have any evidence of myeloma defining events based on the International Myeloma Working Group (IMWG) myeloma diagnostic criteria (SLIM-CRAB). This excludes the light chain ratio criteria of involved versus uninvolved free light chains (FLC) over 100 in the absence of CRAB criteria.
  • Age ≥ 18 years
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤2
  • Participants must meet the following organ and marrow function as defined below: Absolute neutrophil count ≥1,000/mcL, Absolute platelet count ≥50,000/mcL, Direct bilirubin ≤1.5 × institutional upper limit of normal (ULN) AST(SGOT)/ALT(SGPT) ≤3 × institutional ULN.
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  • Participants must have a clonal plasma cell burden of less than 40%.
  • 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 viral load.
  • AL Amyloidosis Cardiac stage I, II or IIIa disease based on the 2015 European Modification of the 2004 Standard Mayo Clinic Staging in participants with advanced cardiac involvement (Dispenzieri et al., 2004; Wechalekar et al., 2013) (NT-proBNP <8500 ng/L and troponin criteria per staging system).
  • 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 pregnancy. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation and until 90 days since the last dose of Elranatamab. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 90 days after completion of Elranatamab administration.
  • 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.

Who cannot join

  • Participants who are receiving any other investigational agents for this condition.
  • Participants with Stage IIIB Amyloidosis as defined by the Europeans Revised 2004 Mayo Clinic Criteria.
  • 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 from which the participant is currently in remission and has been for over 2 years; low-risk prostate cancer with a Gleason score < 7 and prostate specific antigen < 10ng/mL; other localized, indolent and/or low risk cancer may be permitted.
  • 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 because Elranatamab is an agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with Elranatamab, breastfeeding should be discontinued if the mother is treated with Elranatamab.
  • 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 with active clinically significant autoimmune diseases.
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  • 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 or solid organ 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 Left Ventricular (LV) systolic dysfunction as defined by Left Ventricular Ejection Fraction (LVEF) is < 30% by echocardiogram at Screening per site cardiology interpretation.
  • 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 cardioverter-defibrillator (ICD) is not placed.
  • 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 (Mobitz Type 1/Wenckebach type); Right or left bundle branch block (e.g., Left Bundle Branch Block, Right Bundle Branch Block, Left Anterior Fascicular Block, or Left Posterior Fascicular Block); Atrial fibrillation with a controlled ventricular rate; Bifascicular block assessed as benign by the Investigator
  • Major surgery that required general anesthesia within 4 weeks of randomization or is planning major surgery during the study.
  • NYHA class IV symptoms
  • Participants with a Glomerular Filtration Rate (GFR) <20, unless stable on dialysis for at least 3 months

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Sandra Mazzoni, DO contact

216-444-8111

mazzons@ccf.org

United States2 sites

  • Case Comprehensive Cancer Center, Cleveland Clinic Foundation Taussig Cancer Institute

    Cleveland, Ohio, 44195

    Sandra Mazzoni, DO, 216-444-8111, mazzons@ccf.org

    Sandra Mazzoni, DO

  • Mayo Clinic

    Rochester, Minnesota, 55902

    Taxiarchis Kourelis, MD, 507-284-2511, Kourelis.taxiarchis@mayo.edu

    Taxiarchis Kourelis, MD

Other trials in United States

About this study

Official title: Dose Schedule Investigation of B-Cell Maturation Antigen (BCMA) Bispecific Antibody, Elranatamab, for Treatment of Newly Diagnosed Light Chain Amyloidosis

This research study is for people who have newly diagnosed with AL (light chain) amyloidosis and have not yet received any treatment for this condition. The purpose of this study is to evaluate whether elranatamab, a type of immunotherapy drug, can produce deep remissions and organ recovery in people with newly diagnosed AL amyloidosis, and to compare two different dosing schedules.

Elranatamab (brand name ELREXFIO™) is an investigational (experimental) drug in the setting of AL amyloidosis. It works by connecting immune cells (T-cells) directly to the abnormal plasma cells that are causing amyloidosis, triggering the immune system to destroy those cells. It is not approved by the Food and Drug Administration (FDA) for use in AL amyloidosis.

Read more

Participants in this study will receive elranatamab as a series of injections under the skin (subcutaneously) over 6 treatment cycles (approximately 6 months). Treatment begins with inpatient "step-up" doses designed to reduce side effects, followed by two different dosing schedules based on which study arm participants are randomly assigned to. Participants will have regular blood tests, physical exams, bone marrow biopsies, and heart assessments throughout the study, and follow-up visits for up to 2 years after treatment ends.

This study is randomized, meaning that participants will be assigned by chance (similar to a coin flip) to one of two treatment arms. Participants cannot choose their arm.

Participation in this research will last approximately 6 months of active treatment, followed by follow-up visits for up to 2 years (with an option to extend to 5 years).

Read the detailed description

Immunoglobulin light chain (AL) amyloidosis is a disorder of a certain type of blood cell (plasma cells). With this disorder, some plasma cells make abnormal, misfolded light chain proteins that can build up in tissues and organs, damaging them over time. In the United States, about 5 in every 100,000 people have this disorder. Even though it is rare, it can be very serious. Many people who have this disease are very sick upon diagnosis and require care from many different types of doctors. Cardiac (heart) involvement is the most common reason why people may get very sick and die. Contemporary plasma cell directed therapy has helped to improve outcomes, but many people still do not respond quickly or strongly enough. Some people still have worsening organ damage or cannot handle the strong treatments due to organ damage. In fact, early mortality is common, especially in people with cardiac involvement. There is a need for treatments that can quickly and safely lower harmful light chain levels, especially for people whose organs are already affected by the disease.

Elranatamab is a type of drug called a bispecific antibody that connects a B cell maturation antigen (BCMA), a protein on plasma cells, with CD3, a protein on T cells. It can redirect T cells to kill plasma cells that are expressing BCMA. Treatments that use elranatamab have led to positive responses in people with multiple myeloma, a type of blood disease. There is early evidence to show that this drug may also help people with AL amyloidosis. This study will test elranatamab given for a set period of time in people with newly diagnosed AL amyloidosis. It will use two dosing schedules designed to balance efficacy with infection and tolerability risk in a population that is medically fragile.

Being tested
BCMA bispecific
Keywords
B-Cell Maturation Antigen, Elranatamab, Step-up dosing, Bispecific
Medical subject headings
Immunoglobulin Light-chain Amyloidosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BCMA bispecificDrug

    Also called Elranatamab, ELREXFIO™

    All Participants will receive standard step-up dosing (SUD) of BCMA bispecific (elranatamab) in Cycle 1. They will then have 5 additional 28-day cycles on two different dose schedules, for a total duration of 6 months.

Study groups in NCT07524634
Study groupRoleWhat they receive
Arm A: SUD followed by Arm A dose schedulingExperimentalParticipants in Arm A will receive standard step-up dosing (SUD) with one dose a week after SUD, followed by Arm A dose scheduling with a fixed duration of 6 months of BCMA bispecific.
Receives: Drug: BCMA bispecific
Arm B: SUD followed by Arm B dose schedulingExperimentalParticipants in Arm B will receive standard step-up dosing (SUD) with one dose a week after SUD, followed by Arm B dose scheduling with a fixed duration of 6 months of BCMA bispecific.
Receives: Drug: BCMA bispecific

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Efficacy of BCMA bispecific in treating newly diagnosed AL Amyloid, as measured by hematologic complete response (hCR) rates

    hCR rate is defined as the proportion of participants who experience a normalization of free light chain (FLC) levels with negative serume and urine immunofixation, measured through blood tests, at the end of therapy.

    Measured: At end of therapy (after 6 cycles, up to 6 months)

Secondary outcomes (14)

  1. Time to complete hematologic response (hCR)

    Time to complete hCR is defined as the length of time from the start of treatment to time of complete hCR.

    Measured: Up to 6 months

  2. Overall Response rate (ORR)

    ORR is defined as the percentage of participants in Arm A vs Arm B who show a partial, very good partial or complete, hematological response from start of treatment to the end of treatment.

    Measured: At end of therapy (after 6 cycles, up to 6 months)

  3. Duration of hematologic response

    Duration of hematologic response is defined as the length of time in Arm A vs Arm B from first hematologic response until the disease progresses or the participant dies, whichever comes first.

    Measured: Up to 6 months

  4. Progression free survival (PFS) rate

    PFS rate is defined as the length of time from start of treatment until the disease progresses, the participant dies, or the trial ends, in Arm A vs Arm B.

    Measured: Up to 60 months

  5. Overall survival

    Overall survival is defined as the length of time from start of treatment until death, in Arm A vs Arm B.

    Measured: Up to 60 months

  6. Percentage of participants who achieve organ response

    Percentage of participants in Arm A vs Arm B who achieve organ (i.e., renal and cardiac) response.

    Measured: Up to 60 months

  7. Time between the first treatment and first recorded involved organ response

    Length of time between the first treatment and the best recorded involved organ response in Arm A vs Arm B.

    Measured: Up to 60 months

  8. Major organ deterioration progression free survival (MOD-PFS)

    MOD-PFS is defined as the length of time from start of treatment until organ deterioration response (heart, kidney, liver, and peripheral nervous system), the participant dies, the trial ends, or cessation of study drug due to a cause other than documented progression.

    Measured: Up to 60 months

  9. Hospitalization rate

    Hospitalization rate is defined as the percentage of subjects in Arm A vs Arm B that are hospitalized over time from the start of treatment to the end of the observed study follow up period.

    Measured: Up to 60 months

  10. Rates of disease

    Rates of disease is defined as the percentage of subjects in Arm A vs Arm B that experience a cardiac event or an infection from the start of treatment to observed study follow up period.

    Measured: Up to 60 months

  11. Minimal Residual Disease (MRD) negativity rates at end of therapy

    MRD negativity rates are measured from MRD test results of bone marrow aspirate samples using next generation flow cytometry with 10^-5 sensitivity.

    Measured: At end of therapy (after 6 cycles, up to 6 months)

  12. Minimal Residual Disease (MRD) negativity rates at 24 months

    MRD negativity rates are measured from MRD test results of bone marrow aspirate samples using next generation flow cytometry with 10^-5 sensitivity.

    Measured: At 24 months

  13. Change in Quality of life (QoL)

    QoL is measured using the Short Form 36 Questionnaire (SF-36) score. The questionnaire has 19 questions assessing frequency and severity of symptoms impacting quality of life that are answered on a 5-point Likert scale from Excellent/All of the time (4) to Very Severe/None of the time (0). Seven questions assess behaviors impacting quality of life answered Yes or No. Answers are scored, and higher scores indicate greater quality of life.

    Measured: Baseline, end of treatment (up to 6 months)

  14. Rates of hypogammaglobulinemia, defined as IgG levels of <500

    Hypogammaglobulinemia is defined as IgG levels of <500.

    Measured: Up to 60 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Apr 2026
  2. Study startAug 2026 (estimated)
  3. Primary completionJun 2031 (estimated)
  4. Study completionJun 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
64 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07524634
Sponsor's protocol ID
CASE1A26
Status last verified
Aug 2026
First submitted
6 Apr 2026
Last updated
5 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: All participant data will be shared via peer-reviewed publication as a combined summary. Any individual outcomes published per participant will be deidentified utilizing the subject ID (eg. Dose level, demographics, adverse events etc.).

Publications

  • Kastritis E, Palladini G, Minnema MC, Wechalekar AD, Jaccard A, Lee HC, Sanchorawala V, Gibbs S, Mollee P, Venner CP, Lu J, Schonland S, Gatt ME, Suzuki K, Kim K, Cibeira MT, Beksac M, Libby E, Valent J, Hungria V, Wong SW, Rosenzweig M, Bumma N, Huart A, Dimopoulos MA, Bhutani D, Waxman AJ, Goodman SA, Zonder JA, Lam S, Song K, Hansen T, Manier S, Roeloffzen W, Jamroziak K, Kwok F, Shimazaki C, Kim JS, Crusoe E, Ahmadi T, Tran N, Qin X, Vasey SY, Tromp B, Schecter JM, Weiss BM, Zhuang SH, Vermeulen J, Merlini G, Comenzo RL; ANDROMEDA Trial Investigators. Daratumumab-Based Treatment for Immunoglobulin Light-Chain Amyloidosis. N Engl J Med. 2021 Jul 1;385(1):46-58. doi: 10.1056/NEJMoa2028631.

    PubMed 34192431

  • Chakraborty R, Bhutani D, Mapara M, Reshef R, Maurer MS, Radhakrishnan J, Lentzsch S. Reduced early mortality with Daratumumab-based frontline therapy in AL amyloidosis: A retrospective cohort study. Am J Hematol. 2024 Mar;99(3):477-479. doi: 10.1002/ajh.27179. Epub 2023 Dec 15. No abstract available.

    PubMed 38100285

  • Lesokhin AM, Tomasson MH, Arnulf B, Bahlis NJ, Miles Prince H, Niesvizky R, Rodriotaguez-Otero P, Martinez-Lopez J, Koehne G, Touzeau C, Jethava Y, Quach H, Depaus J, Yokoyama H, Gabayan AE, Stevens DA, Nooka AK, Manier S, Raje N, Iida S, Raab MS, Searle E, Leip E, Sullivan ST, Conte U, Elmeliegy M, Czibere A, Viqueira A, Mohty M. Elranatamab in relapsed or refractory multiple myeloma: phase 2 MagnetisMM-3 trial results. Nat Med. 2023 Sep;29(9):2259-2267. doi: 10.1038/s41591-023-02528-9. Epub 2023 Aug 15.

    PubMed 37582952

  • Vianna P, Chakraborty R, Hossain S, Bhutani D, Miller S, Rossi A, Cuddy SAM, Falk RH, Lentzsch S, Laubach JP, Bianchi G. Safety and efficacy of elranatamab in patients with relapsed and/or refractory immunoglobulin light-chain amyloidosis. Blood. 2025 Oct 16;146(16):1929-1935. doi: 10.1182/blood.2025028383.

    PubMed 40712156

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BCMA bispecific in people with Amyloid Light-chain Amyloidosis, run by Case Comprehensive Cancer Center at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Sandra Mazzoni, DO (216-444-8111, mazzons@ccf.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Efficacy of BCMA bispecific in treating newly diagnosed AL Amyloid, as measured by hematologic complete response (hCR) rates (time frame: At end of therapy (after 6 cycles, up to 6 months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07524634, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2026.

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