Study of Teclistamab in Combination in Elderly Patients With Multiple Myeloma

Last updated: July 31, 2024
Sponsor: University Hospital, Lille
Overall Status: Active - Recruiting

Phase

2

Condition

Multiple Myeloma

Cancer

Leukemia

Treatment

Teclistamab

Daratumumab

Lenalidomide

Clinical Study ID

NCT05572229
2022_0174
2022-001594-31
  • Ages > 65
  • All Genders

Study Summary

The primary hypothesis of this study is that teclistamab SC in combination with daratumumab SC or lenalidomide will be safe and induce a high rate of VGPR or better in newly diagnosed multiple myeloma patients

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patient must be at least ≥65 years of age at the time of informed consent withdocumented 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 FLCratio

  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 personduring the study and for a minimum of 4 weeks after the last dose of lenalidomide orfor a period of 3 months after the last dose of other study treatments, whicheveroccurs 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 malepatient is vasectomized, he still must wear a condom (with or without spermicidalfoam/gel/film/cream/suppository), but his female partner is not required to usecontraception.

  6. A male patient must agree not to donate sperm for the purpose of reproduction duringthe study and for a minimum of 4 weeks after the last dose of lenalidomide or forperiod of 3 months after receiving the last dose of other study treatments,whichever occurs later.

  7. Must sign an ICF (or their legally acceptable representative must sign in accordancewith local requirements) indicating that the patient understands the purpose of, andprocedures required for, the study and is willing to participate in the study.

  8. Must be willing and able to adhere to the lifestyle restrictions specified in thisprotocol.

Exclusion

Exclusion Criteria:

Medical Conditions

  1. CNS involvement or clinical signs of meningeal involvement of multiple myeloma. Ifeither 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), orprimary light chain amyloidosis.

  3. Any ongoing myelodysplastic syndrome or B cell malignancy (other than multiplemyeloma).

  4. Any history of malignancy, other than multiple myeloma, which is considered at highrisk 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 forpatients with known or suspected of having COPD or asthma and patients must beexcluded if FEV1 <50% of predicted normal.

  9. Moderate or severe persistent asthma within the past 2 years or uncontrolled asthmaof any classification. Note that FEV1 testing is required for patients known orsuspected 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 prednisonewithin 14-days before the first dose of study drug (does not include pretreatmentmedications).

  12. Received a live, attenuated vaccine within 4 weeks before the first dose of studydrug. 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 shortcourse of corticosteroids prior to signing ICF (not to exceed 40 mg ofdexamethasone, or equivalent per day for a maximum of 4 days, total of 160 mgdexamethasone or equivalent).

  14. Contraindications or life-threatening allergies, hypersensitivity, or intolerance toany 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. OtherExclusions

  18. Women of childbearing potential

  19. Patient had major surgery or had significant traumatic injury within 2 weeks priorto the start of administration of study treatment, or will not have fully recoveredfrom surgery., or has major surgery planned during the time the patient is expectedto be treated in the study or within 2 weeks after administration of the last doseof study treatment.

  20. Concurrent medical or psychiatric condition or disease that is likely to interferewith study procedures or results.

  21. Patient plans to father a child while enrolled in this study or within 3 monthsafter the last dose of study intervention.

  22. Person under guardianship, trusteeship or deprived of freedom by a judicial oradministrative decision.

Study Design

Total Participants: 74
Treatment Group(s): 3
Primary Treatment: Teclistamab
Phase: 2
Study Start date:
December 21, 2023
Estimated Completion Date:
September 30, 2030

Connect with a study center

  • Chu Amiens - Hopital Sud

    Amiens,
    France

    Site Not Available

  • Chru Angers

    Angers,
    France

    Active - Recruiting

  • Ch D'Avignon

    Avignon,
    France

    Site Not Available

  • Centre Hospitalier de La Cote Basque

    Bayonne,
    France

    Active - Recruiting

  • Chu de Besancon

    Besancon,
    France

    Active - Recruiting

  • Aphp Hopital Avicenne

    Bobigny,
    France

    Site Not Available

  • Chu de Caen

    Caen,
    France

    Active - Recruiting

  • Chu Dijon Bourgogne

    Dijon,
    France

    Site Not Available

  • Ch de Dunkerque

    Dunkerque,
    France

    Site Not Available

  • Chu de Grenoble

    La Tronche,
    France

    Site Not Available

  • Centre Hospitalier de Versailles

    Le Chesnay,
    France

    Active - Recruiting

  • Chu de Lille, Hopital Claude Huriez

    Lille,
    France

    Active - Recruiting

  • Chu Limoges

    Limoges,
    France

    Site Not Available

  • Centre Leon Berard

    Lyon,
    France

    Site Not Available

  • Chr Metz-Thionville

    Metz,
    France

    Site Not Available

  • Chu Montpellier

    Montpellier,
    France

    Site Not Available

  • Hopital E. Muller- Ghrmsa

    Mulhouse,
    France

    Site Not Available

  • Chru de Nancy, Hopitaux de Brabois

    Nancy,
    France

    Active - Recruiting

  • Chu de Nantes Site Hotel Dieu

    Nantes,
    France

    Site Not Available

  • Aphp - Chu Henri Mondor

    Paris,
    France

    Site Not Available

  • Aphp - Hopital Saint Antoine

    Paris,
    France

    Site Not Available

  • Aphp - Hopital Saint Louis

    Paris,
    France

    Site Not Available

  • Chu Bordeaux

    Pessac,
    France

    Site Not Available

  • Chu de Poitiers

    Poitiers,
    France

    Site Not Available

  • Chu de Reims

    Reims,
    France

    Site Not Available

  • Chu Pontchaillou

    Rennes,
    France

    Site Not Available

  • Hopitaux Universitaire de Strasbourg - Hopital Hautepierre

    Strasbourg,
    France

    Active - Recruiting

  • Oncopole Chu Toulouse

    Toulouse,
    France

    Site Not Available

  • Chru Bretonneau

    Tours,
    France

    Active - Recruiting

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