Informations générales (source: ClinicalTrials.gov)
A Phase 2 Study of Teclistamab in Combination With Daratumumab or Lenalidomide in Elderly Patients With Newly Diagnosed Multiple Myeloma
Interventional
Phase 2
University Hospital, Lille (Voir sur ClinicalTrials)
décembre 2023
septembre 2030
16 septembre 2025
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.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| AP-HP - Hôpital Avicenne | Contact (sur clinicalTrials) | ||||
| AP-HP - Hôpital Henri Mondor-Albert Chenevier | Contact (sur clinicalTrials) | ||||
| AP-HP - Hôpital Saint Antoine | Contact (sur clinicalTrials) | ||||
| CH DE VERSAILLES SITE ANDRE MIGNOT | Contact (sur clinicalTrials) | ||||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Aphp - Hopital Saint Louis - Paris - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier de La Cote Basque - Bayonne - France | Contact (sur clinicalTrials) | ||||
| Centre Leon Berard - Lyon - France | Contact (sur clinicalTrials) | ||||
| Ch D'Avignon - Avignon - France | Contact (sur clinicalTrials) | ||||
| Ch de Dunkerque - Dunkerque - France | Contact (sur clinicalTrials) | ||||
| Chr Metz-Thionville - Metz - France | Contact (sur clinicalTrials) | ||||
| Chru Angers - Angers - France | Contact (sur clinicalTrials) | ||||
| Chru Bretonneau - Tours - France | Contact (sur clinicalTrials) | ||||
| Chru de Nancy, Hopitaux de Brabois - Nancy - France | Contact (sur clinicalTrials) | ||||
| Chu Amiens - Hopital Sud - Amiens - France | Contact (sur clinicalTrials) | ||||
| Chu Bordeaux - Pessac - France | Contact (sur clinicalTrials) | ||||
| Chu de Besancon - Besancon - France | Contact (sur clinicalTrials) | ||||
| Chu de Caen - Caen - France | Contact (sur clinicalTrials) | ||||
| Chu de Grenoble - La Tronche - France | Contact (sur clinicalTrials) | ||||
| Chu de Lille, Hopital Claude Huriez - Lille - France | Contact (sur clinicalTrials) | ||||
| Chu de Nantes Site Hotel Dieu - Nantes - France | Contact (sur clinicalTrials) | ||||
| Chu de Poitiers - Poitiers - France | Contact (sur clinicalTrials) | ||||
| Chu de Reims - Reims - France | Contact (sur clinicalTrials) | ||||
| Chu Dijon Bourgogne - Dijon - France | Contact (sur clinicalTrials) | ||||
| Chu Limoges - Limoges - France | Contact (sur clinicalTrials) | ||||
| Chu Montpellier - Montpellier - France | Contact (sur clinicalTrials) | ||||
| Chu Pontchaillou - Rennes - France | Contact (sur clinicalTrials) | ||||
| Hopital E. Muller- Ghrmsa - Mulhouse - France | Contact (sur clinicalTrials) | ||||
| Hopitaux Universitaire de Strasbourg - Hopital Hautepierre - Strasbourg - France | Contact (sur clinicalTrials) | ||||
| Oncopole Chu Toulouse - Toulouse - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
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.
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.
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.