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New drug cocktail aims to tame myeloma in seniors

NCT ID NCT05572229

Disease control Sponsor: University Hospital, Lille 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This study is testing a new drug called teclistamab, given as a shot, together with either daratumumab (another shot) or lenalidomide (a pill) in people aged 65 and older who have just been diagnosed with multiple myeloma and cannot have a stem cell transplant. The goal is to see if these combinations are safe and can shrink the cancer significantly after four cycles of treatment. About 74 participants will be enrolled across multiple centers.

What this could mean

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

Active substance
Teclistamab (a drug given as a shot under the skin) combined with either daratumumab (shot) or lenalidomide (pill)
What this could lead to
If successful, this could offer a new, effective treatment option for elderly patients with newly diagnosed multiple myeloma who cannot undergo a stem cell transplant.
What could go wrong
This is a Phase 2 trial with only 74 participants, so results are preliminary. The combination may cause side effects or not work as well as hoped.

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 74 people

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

Started

Dec 2023

Expected to finish

Sep 2030

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

65 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. Patient must be at least ≥65 years of age at the time of informed consent with documented multiple myeloma as defined by the criteria below: Multiple myeloma diagnosis according to IMWG diagnostic criteria Measurable disease at Screening as defined by any of the following: Serum monoclonal paraprotein (M-protein) level ³ 0.5 g/dL; or Urine M protein level ³ 200 mg/24 hours; or Serum Ig FLC ³ 10 mg/dL and abnormal serum Ig kappa/lambda FLC ratio 2. Have an ECOG performance status score of 0-2 3. Not considered for high-dose chemotherapy and autologous SCT 4. Have clinical laboratory values meeting the criteria during the Screening Phase. 5. A male patient must wear a condom (with spermicidal foam/gel/film/cream/suppository) when engaging in any activity that allows for passage of ejaculate to another person during the study and for a minimum of 4 weeks after the last dose of lenalidomide or for a period of 3 months after the last dose of other study treatments, whichever occurs later. If the male patient's partner is a female of childbearing potential, she must also be practicing a highly effective method of contraception. If the male patient is vasectomized, he still must wear a condom (with or without spermicidal foam/gel/film/cream/suppository), but his female partner is not required to use contraception. 7\. A male patient must agree not to donate sperm for the purpose of reproduction during the study and for a minimum of 4 weeks after the last dose of lenalidomide or for period of 3 months after receiving the last dose of other study treatments, whichever occurs later. 8\. Must sign an ICF (or their legally acceptable representative must sign in accordance with local requirements) indicating that the patient understands the purpose of, and procedures required for, the study and is willing to participate in the study. 9\. Must be willing and able to adhere to the lifestyle restrictions specified in this protocol. Exclusion Criteria: Medical Conditions 1. CNS involvement or clinical signs of meningeal involvement of multiple myeloma. If either is suspected, negative whole brain MRI and lumbar cytology are required. 2. Plasma cell leukemia, Waldenström's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, M-protein, and skin changes), or primary light chain amyloidosis. 3. Any ongoing myelodysplastic syndrome or B cell malignancy (other than multiple myeloma). 4. Any history of malignancy, other than multiple myeloma, which is considered at high risk of recurrence requiring systemic therapy 5. Any active malignancies (ie, progressing or requiring treatment change in the last 24 months) other than multiple myeloma. 6. Stroke, transient ischemic attack, or seizure within 6 months prior to signing ICF. 7. Presence of the a cardiac conditions. Tec-Dara-specific 8. COPD with a FEV1 \<50% of predicted normal. Note that FEV1 testing is required for patients with known or suspected of having COPD or asthma and patients must be excluded if FEV1 \<50% of predicted normal. 9. Moderate or severe persistent asthma within the past 2 years or uncontrolled asthma of any classification. Note that FEV1 testing is required for patients known or suspected asthma and patients must be excluded if FEV1 \<50% of predicted normal. Prior/Concomitant Therapy 10. Radiotherapy within 14 days or focal radiation within 7 days. 11. Received a cumulative dose of corticosteroids equivalent to ≥140 mg of prednisone within 14-days before the first dose of study drug (does not include pretreatment medications). 12. Received a live, attenuated vaccine within 4 weeks before the first dose of study drug. Non-live or non-replicating vaccines authorized for emergency use (eg, COVID-19) are allowed. 13. Any prior therapy for multiple myeloma or smoldering myeloma other than a short course of corticosteroids prior to signing ICF (not to exceed 40 mg of dexamethasone, or equivalent per day for a maximum of 4 days, total of 160 mg dexamethasone or equivalent). 14. Contraindications or life-threatening allergies, hypersensitivity, or intolerance to any study drug or its excipients. Diagnostic Assessments 15. HIV positive. 16. Hepatitis B infection. 17. Active hepatitis C infection as measured by positive HCV-RNA testing. Other Exclusions 18. Women of childbearing potential 19. Patient had major surgery or had significant traumatic injury within 2 weeks prior to the start of administration of study treatment, or will not have fully recovered from surgery., or has major surgery planned during the time the patient is expected to be treated in the study or within 2 weeks after administration of the last dose of study treatment. 20. Concurrent medical or psychiatric condition or disease that is likely to interfere with study procedures or results. 21. Patient plans to father a child while enrolled in this study or within 3 months after the last dose of study intervention. 22. Person under guardianship, trusteeship or deprived of freedom by a judicial or administrative decision.

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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

How to take part

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

  1. The places running it

    23 sites. 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

  • Aphp - Chu Henri Mondor

    ACTIVE_NOT_RECRUITING

    Paris, France

  • Aphp - Hopital Saint Antoine

    NOT_YET_RECRUITING

    Paris, France

  • Aphp - Hopital Saint Louis

    NOT_YET_RECRUITING

    Paris, France

  • Aphp Hopital Avicenne

    NOT_YET_RECRUITING

    Bobigny, France

  • Centre Hospitalier de La Cote Basque

    RECRUITING

    Bayonne, France

  • Centre Hospitalier de Versailles

    RECRUITING

    Le Chesnay, France

  • Centre Leon Berard

    NOT_YET_RECRUITING

    Lyon, France

  • Ch D'Avignon

    ACTIVE_NOT_RECRUITING

    Avignon, France

  • Ch de Dunkerque

    ACTIVE_NOT_RECRUITING

    Dunkirk, France

  • Chr Metz-Thionville

    RECRUITING

    Metz, France

  • Chru Angers

    RECRUITING

    Angers, France

  • Chru Bretonneau

    RECRUITING

    Tours, France

  • Chru de Nancy, Hopitaux de Brabois

    RECRUITING

    Nancy, France

  • Chu Amiens - Hopital Sud

    RECRUITING

    Amiens, France

  • Chu Bordeaux

    RECRUITING

    Pessac, France

  • Chu Dijon Bourgogne

    RECRUITING

    Dijon, France

  • Chu Limoges

    ACTIVE_NOT_RECRUITING

    Limoges, France

  • Chu Montpellier

    RECRUITING

    Montpellier, France

  • Chu Pontchaillou

    ACTIVE_NOT_RECRUITING

    Rennes, France

  • Chu de Besancon

    RECRUITING

    Besançon, France

  • Chu de Caen

    RECRUITING

    Caen, France

  • Chu de Grenoble

    RECRUITING

    La Tronche, France

  • Chu de Lille, Hopital Claude Huriez

    RECRUITING

    Lille, France

  • Chu de Nantes Site Hotel Dieu

    ACTIVE_NOT_RECRUITING

    Nantes, France

  • Chu de Poitiers

    RECRUITING

    Poitiers, France

  • Chu de Reims

    NOT_YET_RECRUITING

    Reims, France

  • Hopital E. Muller- Ghrmsa

    NOT_YET_RECRUITING

    Mulhouse, France

  • Hopitaux Universitaire de Strasbourg - Hopital Hautepierre

    RECRUITING

    Strasbourg, France

  • Oncopole Chu Toulouse

    RECRUITING

    Toulouse, France

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