RecruitingPhase 2interventionalRules rewrite

Phase 2: testing Linvoseltamab for Multiple Myeloma

This is a single-center, single-arm, phase 2 study designed to measure the how well it works and safety of linvoseltamab in multiple myeloma (MM) patients who relapsed following BCMA CAR T-cell therapy, whether standard of care or investigational.

Official registry: https://clinicaltrials.gov/study/NCT07009899 · Medical College of Wisconsin · enrollment listed as 34

What this phase means

Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Linvoseltamab. The registry lists allocation as na. This is a single-center, single-arm, phase 2 study designed to measure the how well it works and safety of linvoseltamab in multiple myeloma (MM) patients who relapsed following BCMA CAR T-cell therapy, whether standard of care or investigational.

They plan to enroll about 34 people at Milwaukee. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

BCMA Bispecific Antibody Therapy for Post-BCMA CAR T-Cell Therapy Relapse (RECLAIM)

Interventions: Linvoseltamab

Primary outcome (registry wording): Overall Response Rate

Who it is for (from inclusion criteria)

Ages 18 Years to any
Eastern Cooperative Oncology Group (ECOG) Performance Status criteria of 0-3
Received any standard of care or investigational BCMA CAR T-cell therapy as their last line of therapy ≥ 6 months prior to enrollment
Must have measurable disease for response assessment as per the IMWG response assessment criteria
a. Note: if a patient does not have measurable serum M or free light chain, evidence of measurable disease by imaging is acceptable (e.g., extramedullary disease, new lesions)
Adequate hepatic function as defined below:
Total bilirubin ≤ 1.5 x the upper limit of the normal range (ULN)
Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 x ULN

Who the registry excludes

Previously on a BCMA-directed therapy other than BCMA CAR T-cell therapy (e.g., BCMA bispecific antibody, BCMA antibody drug conjugate) or T cell engaging therapy (e.g., GPRC5D bispecific antibody, GPRC5D CAR T-cell therapy)
History of neurodegenerative condition, Central Nervous System (CNS) movement disorder, or patients with a history of seizure within 12 months prior to study enrollment
Any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to this protocol
Prior organ transplant requiring immunosuppressive therapy
Known to be human immunodeficiency virus (HIV) positive
Known to have hepatitis A, B, or C active infection
Known allergy to any of the study medications, their analogues, or excipients in the various formulations of any agent

Public study contact (from the registry)

Medical College of Wisconsin Cancer Center Clinical Trials Office

866-680-0505

cccto@mcw.edu

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

1 listed

Froedtert & the Medical College of Wisconsin — Milwaukee, Wisconsin (recruiting)

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Phase 1: testing Linvoseltamab for Multiple Myeloma

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FAQ about this NCT record

Is NCT07009899 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07009899?

Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07009899?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary