A Phase 2 Study to Evaluate Safety and Efficacy of Teclistamab- and Talquetamab-based Combination Regimens in Participants with Newly Diagnosed Transplant Eligible Multiple Myeloma

Status: Recruiting
Location: See all (11) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

Phase 2 Study to Evaluate Safety and Efficacy of Teclistamab- and Talquetamab-based Combination Regimens in Participants with Newly Diagnosed Transplant Eligible Multiple Myeloma OBJECTIVES: The primary objective is to evaluate the safety and tolerability of teclistamab- and talquetamab-based combination regimens over the entire treatment phase for each arm, in participants with ND-TEMM The key secondary objective is to evaluate the efficacy of teclistamab- and talquetamab-based combination regimens as induction and post-transplant maintenance treatments, and teclistamab in combination with talquetamab as replacement for HDT+ASCT following induction

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• \- 18 years of age to 70 years of age, inclusive

• Have an ECOG performance status score of 0 to 2 at screening

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

• Participants in Arms A, A1, B, D, E, E1, F and F1 must also satisfy all of the following criteria to be enrolled in the study:

• 1\. Documented multiple myeloma requiring treatment as defined by the criteria below:

⁃ Multiple myeloma diagnosis according to the IMWG diagnostic criteria

⁃ Measurable disease at screening as defined by any of the following:

∙ Serum M-protein level ≥1.0 g/dL or

‣ Urine M-protein level ≥200 mg/24 hours or

‣ Serum immunoglobulin free light chain level ≥10 mg/dL and abnormal serum free light chain ratio

⁃ 2\. Newly diagnosed participants for whom HDT and ASCT is part of the intended treatment plan (except Arm D participants).

⁃ Participants Arm C and C2 must also satisfy all of the following criteria:

‣ Newly diagnosed multiple myeloma according to IMWG criteria.

‣ Must have received 4 to 6 cycles of 3 or 4 drug-induction therapy that includes a proteasome inhibitor and/or an IMiD with or without anti-CD38 monoclonal antibody and a single or tandem ASCT. Post-ASCT consolidation is permitted for up to 2 cycles as long as the total number of induction plus consolidation cycles does not exceed 6.

⁃ 3 Must have received only one line of therapy and achieved at least a PR as per IMWG 2016 without evidence of progression at the time of enrollment.

⁃ 4\. Must have received HDT and ASCT within 12 months of the start of induction therapy and be within 6 months of the last ASCT (7 months for participants who received consolidation) at the time of enrollment.

Locations
Other Locations
Germany
Charité University Medicin Berlin
RECRUITING
Berlin
Clinic Chemnitz gGmbH
RECRUITING
Chemnitz
University Clinic Technical University Dresden
RECRUITING
Dresden
University Clinic Düsseldorf
RECRUITING
Düsseldorf
University Clinic Freiburg
RECRUITING
Freiburg Im Breisgau
Asklepios Clinic Hamburg Altona
RECRUITING
Hamburg
Hamburg University Clinic Eppendorf
RECRUITING
Hamburg
University Hospital Heidelberg
RECRUITING
Heidelberg
University Clinic Schleswig-Holstein Campus Kiel
RECRUITING
Kiel
Technical University Munich
RECRUITING
Munich
University Würzburg
RECRUITING
Würzburg
Contact Information
Primary
Marc S Raab, Prof. Dr. med
s.gmmg@med.uni-heidelberg.de
+49 6221 56
Time Frame
Start Date: 2022-12-01
Estimated Completion Date: 2028-08-15
Participants
Target number of participants: 130
Treatments
Experimental: Arm A Tec-DRd Induction and Tec-D Maintenance
Arm A participants will receive teclistamab as subcutaneous (SC) injection in combination with daratumumab SC, lenalidomide and dexamethasone in 6 cycles of induction therapy, followed by teclistamab SC injection in combination with daratumumab SC in maximum 18 cycles of maintenance therapy.
Experimental: Arm B Tec-DVRd Induction and Tec-D Maintenance
Arm B participants will receive teclistamab as subcutaneous (SC) injection in combination with daratumumab SC, lenalidomide, dexamethasone and bortezomib in 6 cycles of induction therapy, followed by teclistamab SC injection in combination with daratumumab SC in maximum 18 cycles of maintenance therapy.
Experimental: Arm C Tec-D Maintenance
Arm C participants will receive maximum 18 cycles of teclistamab SC injection in combination with daratumumab SC and lenalidomide as maintenance therapy.
Experimental: Arm A1 Tec-DRd Induction and Tec-D Maintenance
Arm A1 participants will receive teclistamab as subcutaneous (SC) injection in combination with daratumumab SC, lenalidomide and dexamethasone in 6 cycles of induction therapy, followed by teclistamab SC injection in combination with daratumumab SC in maximum 18 cycles of maintenance therapy.
Experimental: Arm C2 Tal-DR Maintenance
Arm C2 participants will receive maximum 18 cycles of talquetamab SC injection in combination with daratumumab SC and lenalidomide as maintenance therapy.
Experimental: Arm D Tec-DRd Induction and Tec-Tal following induction
Arm D participants will receive teclistamab as subcutaneous (SC) injection in combination with daratumumab SC, lenalidomide and dexamethasone in 6 cycles of induction therapy, followed by a combination of teclistamab and talquetamab SC injection in maximum 18 cycles of following induction therapy.
Experimental: Arm E Tal-DRd Induction and Tec-D Maintenance
Arm E participants will receive talquetamab as subcutaneous (SC) injection in combination with daratumumab SC, lenalidomide and dexamethasone in 6 cycles of induction therapy, followed by teclistamab SC injection in combination with daratumumab SC in maximum 18 cycles of maintenance therapy.
Experimental: Arm E1 Tal-DRd Induction and Tal-D Maintenance
Arm E1 participants will receive talquetamab as subcutaneous (SC) injection in combination with daratumumab SC, lenalidomide and dexamethasone in 6 cycles of induction therapy, followed by talquetamab SC injection in combination with daratumumab SC in maximum 18 cycles of maintenance therapy.
Experimental: Arm F Tal-DVRd Induction and Tec-D Maintenance
Arm F participants will receive talquetamab as subcutaneous (SC) injection in combination with daratumumab SC, bortezomib, lenalidomide and dexamethasone in 6 cycles of induction therapy, followed by teclistamab SC injection in combination with daratumumab SC in maximum 18 cycles of maintenance therapy.
Experimental: Arm F1 Tal-DVRd Induction and Tal-D Maintenance
Arm F1 participants will receive talquetamab as subcutaneous (SC) injection in combination with daratumumab SC, bortezomib, lenalidomide and dexamethasone in 6 cycles of induction therapy, followed by talquetamab SC injection in combination with daratumumab SC in maximum 18 cycles of maintenance therapy.
Related Therapeutic Areas
Sponsors
Leads: University of Heidelberg Medical Center
Collaborators: Janssen Research & Development, LLC, Deutsche Studiengruppe Multiples Myelom (DSMM)

This content was sourced from clinicaltrials.gov

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