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New drug duo aims to control two cancers at once

NCT ID NCT07638683

Disease control Sponsor: Shanghai Zhongshan Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Aug 04, 2026 · Updated 2 times

Summary

This study tests whether combining two drugs, teclistamab and daratumumab, can help people newly diagnosed with both multiple myeloma and light chain amyloidosis. About 30 adults will receive the treatment for up to 24 cycles. The goal is to see if the combo improves survival without the disease getting worse, and to check for side effects.

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

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2026

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

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: 1. Age ≥18 years, any sex/gender 2. Diagnosis of multiple myeloma according to IMWG criteria 3. Histopathologic diagnosis of AL amyloidosis confirmed by: * Green birefringence under polarized light microscopy with Congo red staining; AND at least one of the following: 1. Immunohistochemistry and/or immunofluorescence 2. Mass spectrometry 3. Electron microscopy/immunoelectron microscopy 4. Measurable disease at screening 5. Newly diagnosed, no prior anti-plasma cell therapy 6. Adequate laboratory values: * Hemoglobin ≥7.5 g/dL * Absolute neutrophil count ≥1.0×10⁹/L * Platelet count ≥70×10⁹/L (platelet transfusion acceptable; \>50×10⁹/L if ≥50% bone marrow nucleated cells are plasma cells) * ALT ≤2.5× upper limit of normal (ULN) * AST ≤2.5× ULN * Total bilirubin ≤2.0× ULN * Creatinine clearance ≥30 mL/min * Corrected serum calcium ≤14 mg/dL 7. Male and female participants of childbearing potential must use at least 2 effective contraceptive methods during the study 8. Voluntarily signed informed consent form (ICF) Exclusion Criteria: 1. Prior anti-myeloma therapy or stem cell transplantation 2. Diagnosis of monoclonal gammopathy of undetermined significance (MGUS), smoldering multiple myeloma, primary AL amyloidosis without concurrent MM, Waldenström macroglobulinemia, plasma cell leukemia, POEMS syndrome, or other malignancies within 3 years prior to enrollment 3. Active infection or autoimmune disease 4. Uncontrolled diabetes, hypertension, or other comorbidities 5. Pregnant or lactating female 6. Currently participating in another interventional study 7. Any other condition that the investigator considers unsuitable for study participation

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Conditions

The condition(s) this trial relates to.

AL amyloidosis Immunoglobulin Light-chain Amyloidosis plasma cell myeloma

As listed by the trial registrant

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

Al amyloidosis Multiple myeloma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Zhongshan Hospital Fudan University

    RECRUITING

    Shanghai, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.