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New study aims for Long-Term remission in Standard-Risk myeloma

NCT ID NCT06577025

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Aug 28, 2026 · Updated 3 times

Summary

This study is for people newly diagnosed with a standard-risk form of multiple myeloma, a blood cancer. Researchers want to see if giving a sequence of advanced cell therapies (Cilta-cel, Tal-D, Tec-D) after initial chemotherapy can lead to a very deep and lasting remission, possibly with no detectable cancer cells for at least 2 years. The goal is to improve long-term outcomes and potentially achieve a state close to a cure, though ongoing monitoring will be needed.

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

43 people

The number who actually took part.

Started

Aug 2024

Expected to finish

Sep 2030

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 to 70 years

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: * Participants with documented new diagnosis of multiple myeloma (MM) according to international myeloma working group (IMWG) diagnostic criteria and with no prior myeloma-directed therapy * Participants must have standard-risk MM (stage I and II) based on revised International Staging System (R-ISS) * Participants must be considered fit (score equals to \[=\] 0) or intermediate-fit (score=1) according to IMWG Frailty Index assessment (based on the Charlson Comorbidity Index, the Katz Activity of Daily Living and the Lawson Instrumental Activities of Daily Living) * Measurable disease defined as: Serum monoclonal paraprotein (M-protein) level greater than or equal to (\>=) 1.0 gram per deciliter (g/dL) (\>=10 gram per liter \[g/L\] for institutions using alternative units) or urine M-protein level \>= 200 milligrams per 24 hours (mg/24 hours); Light chain MM without measurable disease in the serum or the urine: Serum immunoglobulin free light chain \>=10 milligrams per deciliter (mg/dL) (\>=100 mg/L for institutions using alternative units) and abnormal serum immunoglobulin kappa lambda free light chain ratio * Eastern Cooperative Oncology Group (ECOG) performance status grade of 0 or 1 Exclusion Criteria: * Any ongoing myelodysplastic syndrome or B-cell malignancy (other than MM). Any history of malignancy, other than MM, which is considered at high risk of recurrence requiring systemic therapy * Peripheral neuropathy or neuropathic pain of Grade \>= 2, as defined by National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 * Known active or prior history of central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of MM * Stroke or seizure within 6 months of signing the informed consent form (ICF) * Plasma cell leukemia at the time of diagnosis or any time thereafter through apheresis (\>= 5 percent \[%\] circulating plasma cells in peripheral blood smears), Waldenstrom macroglobulinemia, polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes(POEMS) syndrome, or primary amyloid light chain amyloidosis with associated organ dysfunction * Presence of high-risk disease features: (a) Cytogenetic high risk lesions by MM fluorescence in situ hybridization (FISH) including deletion 17p (del\[17p\])/, t(4;14), t(14;16), amplification 1q (amp\[1q21\]) (\>= 4 copies); (b) Presence of 1 or more extramedullary plasmacytomas * Seropositive for human immunodeficiency virus (HIV)

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Conditions

The condition(s) this trial relates to.

plasma cell myeloma

As listed by the trial registrant

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

Multiple myeloma

Contacts and locations

Locations

  • City of Hope

    Duarte, California, 91010, United States

  • Fundacao Antonio Prudente A C Camargo Cancer Center

    São Paulo, 01509 900, Brazil

  • Hosp Clinico Univ de Salamanca

    Salamanca, 37007, Spain

  • Hosp. Univ. 12 de Octubre

    Madrid, 28041, Spain

  • Hosp. Univ. Marques de Valdecilla

    Santander, 39008, Spain

  • IDOR - Regional Bahia

    Salvador, 41253-190, Brazil

  • Levine Cancer Institute

    Charlotte, North Carolina, 28204, United States

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065, United States

  • Peter MacCallum Cancer Centre

    Melbourne, 3000, Australia

  • Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein

    São Paulo, 05652 900, Brazil

  • The Alfred Hospital

    Melbourne, 3004, Australia

  • Universitaetsklinikum Heidelberg

    Heidelberg, 69120, Germany

  • Universitaetsklinikum Tuebingen

    Tübingen, 72076, Germany

  • Universitatsklinikum Wurzburg

    Würzburg, 97080, Germany

  • University of California San Francisco

    San Francisco, California, 94143, United States

  • University of Iowa Hospital and Clinics

    Iowa City, Iowa, 52242, United States

More trials for these conditions

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