Study of Teclistamab in Combination in Elderly Patients With Multiple Myeloma
NCT ID: NCT05572229
Last Updated: 2025-09-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
74 participants
INTERVENTIONAL
2023-12-21
2030-09-30
Brief Summary
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This is an open-label, multicenter, non-comparative, 2-cohort, 2-stage with interruption of enrollment for an efficacy and safety interim analysis, interventional Phase 2 study evaluating the efficacy and safety of a combination with Tec-Dara (Cohort A) or Tec-Len (Cohort B) in patients with newly diagnosed multiple myeloma who are not eligible for SCT.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Tec-Dara
For patients assigned to cohort A (Tec-Dara) patients will receive Tec-Dara until documented PD or unacceptable toxicity
Teclistamab
Teclistamab will be administered via a subcutaneous injection (SC)
Daratumumab
Daratumumab will be administered via a subcutaneous injection (SC)
Tec-Len
For patients assigned to cohort B (Tec-Len) patients will receive Tec-Len until documented PD or unacceptable toxicity
Teclistamab
Teclistamab will be administered via a subcutaneous injection (SC)
Lenalidomide
Lenalidomide will be administered orally
Interventions
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Teclistamab
Teclistamab will be administered via a subcutaneous injection (SC)
Daratumumab
Daratumumab will be administered via a subcutaneous injection (SC)
Lenalidomide
Lenalidomide will be administered orally
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
65 Years
ALL
No
Sponsors
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Janssen Pharmaceutica N.V., Belgium
INDUSTRY
University Hospital, Lille
OTHER
Responsible Party
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Principal Investigators
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Salomon MANIER, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Lille
Locations
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Chu Amiens - Hopital Sud
Amiens, , France
Chru Angers
Angers, , France
Ch D'Avignon
Avignon, , France
Centre Hospitalier de La Cote Basque
Bayonne, , France
Chu de Besancon
Besançon, , France
Aphp Hopital Avicenne
Bobigny, , France
Chu de Caen
Caen, , France
Chu Dijon Bourgogne
Dijon, , France
Ch de Dunkerque
Dunkirk, , France
Chu de Grenoble
La Tronche, , France
Centre Hospitalier de Versailles
Le Chesnay, , France
Chu de Lille, Hopital Claude Huriez
Lille, , France
Chu Limoges
Limoges, , France
Centre Leon Berard
Lyon, , France
Chr Metz-Thionville
Metz, , France
Chu Montpellier
Montpellier, , France
Hopital E. Muller- Ghrmsa
Mulhouse, , France
Chru de Nancy, Hopitaux de Brabois
Nancy, , France
Chu de Nantes Site Hotel Dieu
Nantes, , France
Aphp - Chu Henri Mondor
Paris, , France
Aphp - Hopital Saint Antoine
Paris, , France
Aphp - Hopital Saint Louis
Paris, , France
Chu Bordeaux
Pessac, , France
Chu de Poitiers
Poitiers, , France
Chu de Reims
Reims, , France
Chu Pontchaillou
Rennes, , France
Hopitaux Universitaire de Strasbourg - Hopital Hautepierre
Strasbourg, , France
Oncopole Chu Toulouse
Toulouse, , France
Chru Bretonneau
Tours, , France
Countries
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Central Contacts
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Other Identifiers
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2022-001594-31
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2022_0174
Identifier Type: -
Identifier Source: org_study_id
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