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
160 participants
INTERVENTIONAL
2022-12-01
2029-09-15
Brief Summary
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OBJECTIVES:
To evaluate the safety and tolerability of teclistamab-, talquetamab-, and JNJ-79635322-based combination regimens over the entire treatment phase for each arm, in participants with ND-TEMM
To evaluate the efficacy of teclistamab- and talquetamab-based combination regimens as induction and post-transplant maintenance treatments; JNJ-79635322-based combinations as induction and as replacement for HDT+ASCT following induction; and teclistamab in combination with talquetamab
Detailed Description
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160 participants will be enrolled with 10 participants in Arm A, 20 participants in Arm A1, 20 participants in Arm B, 10 participants in Arms C and 10 in C2, 20 participants in Arm D, 10 participants in each Arm E, E1 and optionally F and F, and 20 participants in Arm G. Cohorts may be further expanded.
Arms A, A1, B, D, E, E1, F, F1 will receive Induction therapy of 6 cycles (28-days each):
Treatment: Tec-DRd (Arm A, A1), Tec-DVRd (Arm B), Tal-DRd (Arms E, E1), Tal-DVRd (Arms F, F1) followed by HDT and a single ASCT according to local SoC treatment. Thereafter a Maintenance Therapy of maximum 18 cycles with either Tec-D (Arms A, A1, B, E, F) or Tal-D (E1, F1) is performed.
Arm D will receive 6 28-days cycles Tec-DVRd induction followed by 18 cycles Tec-Tal. Arm G will receive 6 28-day cycles of JNJ-79635322-DRd induction, followed by JNJ-79635322-D. No HDT ASCT will be performed in Arm D and Arm G.
In Arm C and C2 participants will enter the study for maintenance treatment of 18 cycles with Tec-D (Arm C) or Tal-DR (Arm C2) , after induction, HDT and ASCT according to local SoC (outside of the study).
Participants will receive maintenance treatment or following induction treatment (Arm D and G) for a maximum of 18 cycles or until confirmed progressive disease, death, intolerable toxicity, loss to follow-up, or consent withdrawal, whichever comes first. An optional end of treatment is possible for patients who have 12 months sustained MRD negativity.
Periodic safety evaluations will be conducted to ensure that treatment is safe and tolerable. Upon treatment discontinuation, an EOT Visit will be conducted. Thereafter, the participant will continue in the Follow-up Phase until death, withdrawal of consent, loss to follow-up, or end of the study, whichever occurs first.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
Induction therapy (except Arms D and G) is followed by HDT and a single ASCT according to local SoC. Participants will receive maintenance treatment with Tec-D \[Arm A, A1, B, E. F\] or Tal-D \[E1, F1\] or JNJ-79635322-D \[Arm G\].
Arm C, C1 and C2 participants will enter the study at Maintenance Treatment with Tec-D or Tal-DR after induction, HDT, and ASCT according to local SoC (outside of the study).
All Arms receive maintenance treatment for a max. of 18 cycles or until confirmed PD, death, intolerable toxicity, loss to follow-up, or consent withdrawal, whichever comes first. An optional EoT is possible for those patients who have sustained MRD negativity of 12 months.
Periodic safety evaluations will be conducted to ensure that treatment is safe and tolerable.
TREATMENT
NONE
Study Groups
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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.
Teclistamab (Tec)
Subcutaneous administration of Teclistamab
Daratumumab
Subcutaneous administration of Daratumumab
Dexamethasone
administered i.v. or orally
Lenalidomide
Administration oral
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.
Teclistamab (Tec)
Subcutaneous administration of Teclistamab
Daratumumab
Subcutaneous administration of Daratumumab
Dexamethasone
administered i.v. or orally
Lenalidomide
Administration oral
Bortezomib
Subcutaneous administration
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.
Teclistamab (Tec)
Subcutaneous administration of Teclistamab
Daratumumab
Subcutaneous administration of Daratumumab
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.
Teclistamab (Tec)
Subcutaneous administration of Teclistamab
Daratumumab
Subcutaneous administration of Daratumumab
Dexamethasone
administered i.v. or orally
Lenalidomide
Administration oral
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.
Daratumumab
Subcutaneous administration of Daratumumab
Lenalidomide
Administration oral
Talquetamab
Subcutaneous administration of Daratumumab
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.
Teclistamab (Tec)
Subcutaneous administration of Teclistamab
Daratumumab
Subcutaneous administration of Daratumumab
Dexamethasone
administered i.v. or orally
Lenalidomide
Administration oral
Talquetamab
Subcutaneous administration of Daratumumab
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.
Teclistamab (Tec)
Subcutaneous administration of Teclistamab
Daratumumab
Subcutaneous administration of Daratumumab
Dexamethasone
administered i.v. or orally
Lenalidomide
Administration oral
Talquetamab
Subcutaneous administration of Daratumumab
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.
Daratumumab
Subcutaneous administration of Daratumumab
Dexamethasone
administered i.v. or orally
Lenalidomide
Administration oral
Talquetamab
Subcutaneous administration of Daratumumab
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.
Teclistamab (Tec)
Subcutaneous administration of Teclistamab
Daratumumab
Subcutaneous administration of Daratumumab
Dexamethasone
administered i.v. or orally
Lenalidomide
Administration oral
Bortezomib
Subcutaneous administration
Talquetamab
Subcutaneous administration of Daratumumab
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.
Daratumumab
Subcutaneous administration of Daratumumab
Dexamethasone
administered i.v. or orally
Lenalidomide
Administration oral
Bortezomib
Subcutaneous administration
Talquetamab
Subcutaneous administration of Daratumumab
Arm-G JNJ-79635322-DRd induction - JNJ-79635322-D following ind
Arm G participants will receive six 28-day cycles of JNJ-79635322-DRd induction, followed byJNJ-79635322-D treatment for a maximum of eighteen 28-day cycles or until confirmed PD, death, intolerable toxicity, loss to follow-up, or consent withdrawal, whichever comes first. Tec-Tal or JNJ-79635322-D treatment can be discontinued when 12 months of sustained MRD negativity has been observed during the study.
Daratumumab
Subcutaneous administration of Daratumumab
Dexamethasone
administered i.v. or orally
Lenalidomide
Administration oral
JNJ-79635322
Subcutaneous administration
Interventions
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Teclistamab (Tec)
Subcutaneous administration of Teclistamab
Daratumumab
Subcutaneous administration of Daratumumab
Dexamethasone
administered i.v. or orally
Lenalidomide
Administration oral
Bortezomib
Subcutaneous administration
Talquetamab
Subcutaneous administration of Daratumumab
JNJ-79635322
Subcutaneous administration
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Have an ECOG performance status score of 0 to 2 at screening
* Have an ECOG performance status score of 0 to 2 at screening and immediately prior to the start of administration of study treatment
Participants in Arms A, A1, B, D, E, E1, F, F1 and G 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:
1. Multiple myeloma diagnosis according to the IMWG diagnostic criteria
2. Measurable disease at screening as defined by any of the following:
1\. Serum M-protein level ≥1.0 g/dL or 2. Urine M-protein level ≥200 mg/24 hours or 3. 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 and G participants).
Participants Arm C and C2 must also satisfy all of the following criteria:
1. Newly diagnosed multiple myeloma according to IMWG criteria.
2. Must have received 4 to 6 28-day 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 response criteria based on the investigator's assessment. Participants with plasmacytomas at the time of diagnosis must meet IMWG 2016 response criteria for ≥PR based on repeat imaging utilizing the same modality 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.
Exclusion Criteria
\- Stroke or seizure within 6 months prior study start Cycle1 Day1.
\- History of transplantations requiring immunosuppressive therapy.
\- Seropositive for HIV, HEP B, Active Hep C infection (details see protocol).
\- COPD with a FEV1 \<50% of predicted normal.
\- Moderate /severe persistent asthma within the past 2 years or any uncontrolled asthma. Exclude if FEV1 \<50% of predicted normal.
\- Concurrent medical or psychiatric condition or disease that is likely to interfere with study procedures, or that in the investigators opinion would constitute a hazard for participants.
\- Contraindications or life-threatening allergies, hypersensitivity, or intolerance to any study drug/excipients.
\- Pregnant, breastfeeding, or planning to become pregnant while enrolled in this study or within 6 months after the last dose of any study treatment regimen.
\- Plans to father a child while enrolled in this study or within 100 days after the last dose of any component of the study treatment regimen.
Arm A, A1, B, D, E, E1, F, F1
* Prior or current systemic therapy or stem cell transplant for any plasma cell dyscrasia, with the exception of emergency use of a short course (equivalent of dexamethasone 40 mg/day for a maximum 4 days) of corticosteroids before treatment.
* Arm B only: Peripheral neuropathy or neuropathic pain Grade 2 or higher as defined by the NCI-CTCAE Version 5.
Due to a potential interaction with bortezomib, received a strong CYP3A4 inducer within 5 half-lives prior to enrollment
Arm C and C2
\- Discontinued treatment due to any AE related to lenalidomide as determined by the investigator.
* Progressed on multiple myeloma therapy at any time prior to screening.
* Received a cumulative dose of corticosteroids equivalent to ≥40 mg of dexamethasone within the 14 day period before the start of study treatment administration.
* Intolerant to the starting dose of lenalidomide (10 mg).
18 Years
70 Years
ALL
No
Sponsors
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Janssen Research & Development, LLC
INDUSTRY
Deutsche Studiengruppe Multiples Myelom (DSMM)
UNKNOWN
University of Heidelberg Medical Center
OTHER
Responsible Party
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Marc Raab
Prof. Dr. med.
Locations
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Charité University Medicin Berlin
Berlin, , Germany
Clinic Chemnitz gGmbH
Chemnitz, , Germany
University Clinic Technical University Dresden
Dresden, , Germany
University Clinic Düsseldorf
Düsseldorf, , Germany
University Clinic Freiburg
Freiburg im Breisgau, , Germany
Hamburg University Clinic Eppendorf
Hamburg, , Germany
Asklepios Clinic Hamburg Altona
Hamburg, , Germany
University Hospital Heidelberg
Heidelberg, , Germany
University Clinic Schleswig-Holstein Campus Kiel
Kiel, , Germany
Technical University Munich
Munich, , Germany
University Würzburg
Würzburg, , Germany
Countries
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Central Contacts
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Other Identifiers
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GMMG-HD10/DSMM-XX
Identifier Type: -
Identifier Source: org_study_id