News - Talvey (talquetamab-tgvs)

Immune Effector Cell-Associated HLH-Like Syndrome (IEC-HS) in CAR-T and TCE-Treated Myeloma and B-Cell Malignancies: Insights from a Pharmacovigilance Study. (PubMed, Transplant Cell Ther)

IEC-HS is a rare but potentially fatal complication. Our disproportionality analysis identifies significant reporting signals for tisa-cel and cilta-cel. The high absolute number of cases observed for products like axi-cel appears to reflect high utilization rather than a disproportionate risk, underscoring the necessity of using statistical signal detection methods when interpreting spontaneous reports.

4 days ago

Journal • Adverse events

ROR1 (Receptor Tyrosine Kinase Like Orphan Receptor 1)

Yescarta (axicabtagene ciloleucel) • Breyanzi (lisocabtagene maraleucel) • Kymriah (tisagenlecleucel-T) • Epkinly (epcoritamab-bysp) • Elrexfio (elranatamab-bcmm) • Tecartus (brexucabtagene autoleucel) • Abecma (idecabtagene vicleucel) • Carvykti (ciltacabtagene autoleucel) • Lunsumio (mosunetuzumab-axgb) • Talvey (talquetamab-tgvs) • Tecvayli (teclistamab-cqyv) • Columvi (glofitamab-gxbm)

MonumenTAL-8: A Study of Ciltacabtagene Autoleucel and Talquetamab for the Treatment of Participants With High-Risk Multiple Myeloma (clinicaltrials.gov)

P2, N=11, Active, not recruiting, Janssen Research & Development, LLC | Recruiting --> Active, not recruiting

1 month ago

Enrollment closed

Carvykti (ciltacabtagene autoleucel) • Talvey (talquetamab-tgvs)

MMulti-Immune HR; Multi-Target Immunotherapy for High-Risk Multiple Myeloma (clinicaltrials.gov)

P2, N=50, Not yet recruiting, University of Arkansas | Initiation date: Oct 2025 --> Apr 2026

1 month ago

Trial initiation date

clonoSEQ

lenalidomide • Darzalex (daratumumab) • melphalan • Talvey (talquetamab-tgvs) • Tecvayli (teclistamab-cqyv)

2ms

OPTec: Outpatient Administration of Teclistamab or Talquetamab for Multiple Myeloma (clinicaltrials.gov)

P2, N=75, Recruiting, SCRI Development Innovations, LLC | Trial completion date: Mar 2026 --> Oct 2027 | Trial primary completion date: Feb 2026 --> Aug 2027

2 months ago

Trial completion date • Trial primary completion date

Actemra IV (tocilizumab) • Talvey (talquetamab-tgvs) • Tecvayli (teclistamab-cqyv)

2ms

aMMbition: A Study of Different Sequences of Cilta-cel, Talquetamab in Combination With Daratumumab and Teclistamab in Combination With Daratumumab Following Induction With Daratumumab, Bortezomib, Lenalidomide and Dexamethasone in Participants With Standard-risk Newly Diagnosed Multiple Myeloma (clinicaltrials.gov)

P2, N=43, Active, not recruiting, Janssen Research & Development, LLC | Recruiting --> Active, not recruiting

2 months ago

Enrollment closed

lenalidomide • bortezomib • cyclophosphamide • fludarabine IV • Darzalex Faspro (daratumumab and hyaluronidase-fihj) • Carvykti (ciltacabtagene autoleucel) • Talvey (talquetamab-tgvs) • Tecvayli (teclistamab-cqyv)

2ms

MonumenTAL-8: A Study of Ciltacabtagene Autoleucel and Talquetamab for the Treatment of Participants With High-Risk Multiple Myeloma (clinicaltrials.gov)

P2, N=10, Recruiting, Janssen Research & Development, LLC | Trial completion date: Aug 2026 --> Nov 2026

2 months ago

Trial completion date

Carvykti (ciltacabtagene autoleucel) • Talvey (talquetamab-tgvs)

2ms

MonumenTAL-6: A Study Comparing Talquetamab Plus Pomalidomide, Talquetamab Plus Teclistamab, and Elotuzumab, Pomalidomide, and Dexamethasone or Pomalidomide, Bortezomib, and Dexamethasone in Participants With Relapsed or Refractory Myeloma Who Have Received an Anti-CD38 Antibody and Lenalidomide (clinicaltrials.gov)

P3, N=795, Recruiting, Janssen Research & Development, LLC | Trial completion date: Jun 2027 --> Jan 2028

2 months ago

Trial completion date

lenalidomide • bortezomib • pomalidomide • Empliciti (elotuzumab) • Talvey (talquetamab-tgvs) • Tecvayli (teclistamab-cqyv) • dexamethasone injection

2ms

TRIMM-2: A Study of Subcutaneous Daratumumab Regimens in Combination With Bispecific T Cell Redirection Antibodies for the Treatment of Participants With Multiple Myeloma (clinicaltrials.gov)

P1, N=290, Active, not recruiting, Janssen Research & Development, LLC | Trial primary completion date: Aug 2025 --> Apr 2027

2 months ago

Trial primary completion date

pomalidomide • Darzalex Faspro (daratumumab and hyaluronidase-fihj) • Talvey (talquetamab-tgvs) • Tecvayli (teclistamab-cqyv)

2ms

P3, N=795, Recruiting, Janssen Research & Development, LLC | Trial completion date: Jun 2030 --> Jun 2027

2 months ago

Trial completion date

lenalidomide • bortezomib • pomalidomide • Empliciti (elotuzumab) • Talvey (talquetamab-tgvs) • Tecvayli (teclistamab-cqyv) • dexamethasone injection

3ms

A Study of JNJ-64407564 in Japanese Participants With Relapsed or Refractory Multiple Myeloma (clinicaltrials.gov)

P1, N=15, Completed, Janssen Pharmaceutical K.K. | Active, not recruiting --> Completed

3 months ago

Trial completion

Talvey (talquetamab-tgvs)

3ms

REALiTEC: A Study of Clinical Outcomes in Patients With Relapsed/Refractory Multiple Myeloma (RRMM) Treated With T-cell Redirectors Outside of Clinical Trials (clinicaltrials.gov)

P=N/A, N=900, Recruiting, Janssen-Cilag Ltd. | N=600 --> 900 | Trial primary completion date: Jun 2025 --> Jun 2026

3 months ago

Enrollment change • Trial primary completion date

Talvey (talquetamab-tgvs) • Tecvayli (teclistamab-cqyv)

4ms

Talquetamab & Lenalidomide as Post Stem Cell Transplant Maintenance in Multiple Myeloma (clinicaltrials.gov)

P2, N=20, Recruiting, Stanford University | Not yet recruiting --> Recruiting

4 months ago

Enrollment open

clonoSEQ

lenalidomide • Talvey (talquetamab-tgvs)