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

Status: Recruiting
Location: See all (29) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 65
Healthy Volunteers: f
View:

• 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

• Have an ECOG performance status score of 0-2

• Not considered for high-dose chemotherapy and autologous SCT

• Have clinical laboratory values meeting the criteria during the Screening Phase.

• 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.

Locations
Other Locations
France
Chu Amiens - Hopital Sud
RECRUITING
Amiens
Chru Angers
RECRUITING
Angers
Ch D'Avignon
ACTIVE_NOT_RECRUITING
Avignon
Centre Hospitalier de La Cote Basque
RECRUITING
Bayonne
Chu de Besancon
RECRUITING
Besançon
Aphp Hopital Avicenne
NOT_YET_RECRUITING
Bobigny
Chu de Caen
RECRUITING
Caen
Chu Dijon Bourgogne
RECRUITING
Dijon
Ch de Dunkerque
ACTIVE_NOT_RECRUITING
Dunkirk
Chu de Grenoble
RECRUITING
La Tronche
Centre Hospitalier de Versailles
RECRUITING
Le Chesnay
Chu de Lille, Hopital Claude Huriez
RECRUITING
Lille
Chu Limoges
ACTIVE_NOT_RECRUITING
Limoges
Centre Leon Berard
NOT_YET_RECRUITING
Lyon
Chr Metz-Thionville
RECRUITING
Metz
Chu Montpellier
RECRUITING
Montpellier
Hopital E. Muller- Ghrmsa
NOT_YET_RECRUITING
Mulhouse
Chru de Nancy, Hopitaux de Brabois
RECRUITING
Nancy
Chu de Nantes Site Hotel Dieu
ACTIVE_NOT_RECRUITING
Nantes
Aphp - Chu Henri Mondor
ACTIVE_NOT_RECRUITING
Paris
Aphp - Hopital Saint Antoine
NOT_YET_RECRUITING
Paris
Aphp - Hopital Saint Louis
NOT_YET_RECRUITING
Paris
Chu Bordeaux
RECRUITING
Pessac
Chu de Poitiers
RECRUITING
Poitiers
Chu de Reims
NOT_YET_RECRUITING
Reims
Chu Pontchaillou
ACTIVE_NOT_RECRUITING
Rennes
Hopitaux Universitaire de Strasbourg - Hopital Hautepierre
RECRUITING
Strasbourg
Oncopole Chu Toulouse
RECRUITING
Toulouse
Chru Bretonneau
RECRUITING
Tours
Contact Information
Primary
Salomon MANIER, MD
salomon.manier@chru-lille.fr
0320445962
Time Frame
Start Date: 2023-12-21
Estimated Completion Date: 2030-09
Participants
Target number of participants: 74
Treatments
Experimental: Tec-Dara
For patients assigned to cohort A (Tec-Dara) patients will receive Tec-Dara until documented PD or unacceptable toxicity
Experimental: Tec-Len
For patients assigned to cohort B (Tec-Len) patients will receive Tec-Len until documented PD or unacceptable toxicity
Related Therapeutic Areas
Sponsors
Collaborators: Janssen Pharmaceutica N.V., Belgium
Leads: University Hospital, Lille

This content was sourced from clinicaltrials.gov

Similar Clinical Trials