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Teclistamab combined with other treatments for elderly patients with multiple myeloma

A Phase 2 Study of Teclistamab in Combination With Daratumumab or Lenalidomide in Elderly Patients With Newly Diagnosed Multiple Myeloma

Phase 2 Interventional University Hospital, Lille · NCT05572229

This study is testing if combining teclistamab with either daratumumab or lenalidomide can help older patients with newly diagnosed multiple myeloma who can't have a stem cell transplant feel better.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment74 (estimated)
Ages65 Years and up
SexAll
SponsorUniversity Hospital, Lille Academic / other
Drugs / interventionschemotherapy, radiation, prednisone, teclistamab, daratumumab
Locations29 sites (Amiens and 28 other locations)
Trial IDNCT05572229 on ClinicalTrials.gov

What this trial studies

This Phase 2 clinical trial evaluates the safety and efficacy of teclistamab in combination with either daratumumab or lenalidomide in elderly patients who have newly diagnosed multiple myeloma and are not eligible for stem cell transplantation. The study is open-label and multicenter, involving two cohorts to assess the effectiveness of the combinations in achieving a high rate of very good partial response (VGPR) or better. Enrollment will be interrupted for an interim analysis of efficacy and safety.

Who should consider this trial

Good fit: Ideal candidates are patients aged 65 and older with newly diagnosed multiple myeloma who are not eligible for high-dose chemotherapy and autologous stem cell transplantation.

Not a fit: Patients who are younger than 65 or those who are eligible for high-dose chemotherapy and stem cell transplantation may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve outcomes for elderly patients with newly diagnosed multiple myeloma.

How similar studies have performed: Other studies have shown promising results with similar combinations of teclistamab and other agents in treating multiple myeloma, indicating potential for success.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Amiens and 28 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Multiple MyelomaNewly diagnosed Multiple MyelomaElderly patientsTeclistamabDaratumumabLenalidomideToxicity
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.