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New drug combo aims to tame rare heart disease

NCT ID NCT05250973

Disease control Sponsor: Janssen Research & Development, LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Aug 28, 2026 · Updated 4 times

Summary

This phase 2 trial tests a drug combination including daratumumab for people with AL amyloidosis, a rare disease where abnormal proteins damage organs, especially the heart. The study has two groups: one gets the full combo right away, the other starts some drugs later. Researchers are checking heart safety and how the drug works in different racial groups. About 151 newly diagnosed patients are taking part.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Daratumumab (a targeted antibody) combined with cyclophosphamide, bortezomib, and dexamethasone
What this could lead to
If successful, this could lead to a safer and more effective treatment option for AL amyloidosis, especially for patients with heart complications.
What could go wrong
This is a mid-stage trial with only 151 participants, so results may not apply to everyone. Heart-related side effects are a key concern being studied.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

151 people

The number who actually took part.

Started

Mar 2022

Expected to finish

Oct 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Cohort 1: Cardiac involvement (amyloid light chain \[AL\] amyloidosis Mayo Cardiac Stage II and Stage IIIa) with or without other organ(s) involved; Cohort 2: One or more organs impacted by systemic AL amyloidosis according to consensus guidelines * Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0, 1 or 2 * A female participant of childbearing potential must have a negative serum or urine test at screening and within 72 hours of the first dose of study treatment and must agree to further serum or urine pregnancy tests during the study * A male participant must agree not to donate sperm for the purpose of reproduction during the study and for a minimum of 6 months after receiving the last dose of cyclophosphamide or 100 days after discontinuation of daratumumab, whichever is longer * Cohort 2 only: self-identified racial and ethnic minorities, including Black or African American * Measurable disease at screening defined by one of the following: Difference between iFLC and uninvolved FLC (dFLC) \>= 40mg/L per central laboratory Serum involved free light chain (iFLC) \>= 40 mg/L with an abnormal kappa:lambda ratio Serum M-protein \>= 0.5 g/dL Exclusion Criteria: * Prior therapy for systemic AL amyloidosis or multiple myeloma including medications that target cluster of differentiation 38 (CD38), with the exception of 160 milligrams(mg) dexamethasone or equivalent corticosteroid maximum exposure prior to randomization/enrollment * Previous or current diagnosis of symptomatic multiple myeloma, including the presence of lytic bone disease, plasmacytomas, \>=60% plasma cells in the bone marrow, or hypercalcemia related to myeloma. * Participant received any of the following therapies: 1. treatment with an investigational drug or used an invasive investigational medical device within 14 days or at least 5 half-lives, whichever is less; 2. vaccinated with an investigational vaccine (except for COVID-19) live, attenuated or replicating viral vector vaccines less than (\<) 4 weeks prior to randomization/enrollment. Participants who are taking strong Cytochrome P450 3A4(CYP3A4) inducers must discontinue their use at least 5 half-lives prior to the first dose of bortezomib * Stem cell transplantation -Planned stem cell transplant during the first 9 cycles of protocol therapy are excluded. Stem cell collection during the first 9 cycles of protocol therapy is permitted * Grade 2 sensory or Grade 1 painful peripheral neuropathy

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Conditions

The condition(s) this trial relates to.

AL amyloidosis amyloidosis primary systemic amyloidosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Amyloidosis

Contacts and locations

Locations

  • Alexandra General Hospital of Athens

    Athens, 11528, Greece

  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan, 48201, United States

  • Boston University Medical Center

    Boston, Massachusetts, 02118, United States

  • CHU De Poitiers

    Poitiers, 86000, France

  • CHU Rangueil

    Toulouse, 31400, France

  • CHU de Limoges

    Limoges, 87042, France

  • Centre hospitalier Lyon-Sud

    Pierre-Bénite, 69495, France

  • Charite Campus Benjamin Franklin

    Berlin, 12203, Germany

  • City of Hope

    Duarte, California, 91010, United States

  • Clinica Univ. de Navarra

    Pamplona, 31008, Spain

  • Clinica Univ. de Navarra 1

    Madrid, 28027, Spain

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2, Canada

  • DIPARTIMENTO DI BIOTECNOLOGIE CELLULARI ED EMATOLOGIA - UNIVERSITà ''LA SAPIENZA''

    Roma, 00161, Italy

  • First affiliated Hospital of Zhejiang University

    Hangzhou, 310003, China

  • Fondazione IRCCS Policlinico San Matteo

    Pavia, 27100, Italy

  • Hosp Clinic de Barcelona

    Barcelona, 08036, Spain

  • Hosp Clinico Univ de Salamanca

    Salamanca, 37007, Spain

  • Hosp Univ Vall D Hebron

    Barcelona, 08035, Spain

  • Hosp. Univ. Germans Trias I Pujol

    Badalona, 08916, Spain

  • Hospital Maastricht University Medical Center

    Maastricht, 6229 HX, Netherlands

  • Leicester Royal Infirmary - Haematology

    Leicester, LE1 5WW, United Kingdom

  • Levine Cancer Institute

    Charlotte, North Carolina, 28204, United States

  • Memorial Sloan Kettering

    New York, New York, 10065, United States

  • Moffitt Cancer Center

    Tampa, Florida, 33612, United States

  • Ohio Health Research Institute

    Columbus, Ohio, 43214, United States

  • Peking University First Hospital

    Beijing, 100034, China

  • Peking University People's Hospital

    Beijing, 100044, China

  • Ruijin Hospital Shanghai Jiao Tong University

    Shanghai, 200025, China

  • Tom Baker Cancer Center

    Calgary, Alberta, T2N 4N2, Canada

  • Tufts Medical Center

    Boston, Massachusetts, 02111, United States

  • UMC Utrecht

    Utrecht, 3584 CX, Netherlands

  • UT Southwestern Medical Center

    Dallas, Texas, 75390, United States

  • Universitaetsklinikum Heidelberg Medizinische Klinik V

    Heidelberg, 69120, Germany

  • Universitatsklinikum Essen

    Essen, 45122, Germany

  • University College Hospital

    London, NW1 2PG, United Kingdom

  • University Health Network UHN Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 2M9, Canada

  • University Hospital of Cleveland

    Cleveland, Ohio, 44106, United States

  • University Medical Center Groningen

    Groningen, 9713 GZ, Netherlands

  • University of Washington

    Seattle, Washington, 02118-30002, United States

  • Università Degli Studi Di Napoli Federico Ii

    Naples, 80131, Italy

  • VCU Medical Center

    Richmond, Virginia, 23298, United States

  • Wake Forest University - Baptist Medical Center

    Winston-Salem, North Carolina, 27157, United States

  • West China Hospital Si Chuan University

    Chengdu, 610041, China

  • West Penn Hospital

    Pittsburgh, Pennsylvania, 15224, United States

  • Winship Cancer Institute Emory University

    Atlanta, Georgia, 30322, United States

  • Yale

    New Haven, Connecticut, 06520, United States

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