RecruitingPhase 1 / Phase 2interventionalRules rewrite

Phase 1 / Phase 2: testing Cevostamab for Multiple Myeloma

Q: Is NCT05583617 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.

Q: What phase is NCT05583617?

Phase 1 / Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Q: Can PlainTrials tell me if I qualify for NCT05583617?

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

CO43923 is a platform study that will measure the safety, how well it works, and pharmacokinetics (PK) of multiple treatment combinations, as this drug alone or in combination, in participants with multiple myeloma (MM). The study is designed with the flexibility to open new treatment substudies as new treatments become available.

Official registry: https://clinicaltrials.gov/study/NCT05583617 · Hoffmann-La Roche · enrollment listed as 200

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 Cevostamab, Lenalidomide, or Tocilizumab. The registry lists allocation as randomized. CO43923 is a platform study that will measure the safety, how well it works, and pharmacokinetics (PK) of multiple treatment combinations, as this drug alone or in combination, in participants with multiple myeloma (MM).

They plan to enroll about 200 people at 16 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

A Platform Study Evaluating the Safety and Efficacy of Multiple Treatments in Patients With Multiple Myeloma

Interventions: Cevostamab, Lenalidomide, Tocilizumab, Iberdomide, Dexamethasone

Primary outcome (registry wording): Stage 1: Percentage of Participants with Adverse Events (AEs)

Who it is for (from inclusion criteria)

Ages 18 Years to any
Diagnosed with MM per International Myeloma Working Group (IMWG) criteria
Eastern Cooperative Oncology Group Performance Status of 0, or 1, or 2
Resolution of AEs from prior anti-cancer therapy to Grade \<=1
Agreement to undergo scheduled assessments and procedures
Additional who can join for SS2:
Completion of planned induction therapy and achievement of at least a partial response (PR)
Autologous Stem Cell Transplant (SCT) within 100 days prior to first study treatment and the absence of progressive disease

Who the registry excludes

Inability to comply with protocol-mandated hospitalization and procedures
History of confirmed progressive multifocal leukoencephalopathy
History of other malignancy within 2 years prior to screening
Current or past history of central nervous system (CNS) disease
Significant cardiovascular disease that may limit a participant's ability to adequately respond to a CRS event
Symptomatic active pulmonary disease or requiring supplemental oxygen
Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection at study enrollment, or any major episode of infection requiring treatment with IV antibiotics where the last dose of IV antibiotics was given within 14 days prior to first study treatment

Public study contact (from the registry)

Reference Study ID Number: CO43923 https://forpatients.roche.com/ No attachments to email below.

888-662-6728 (U.S. and Canada)

global-roche-genentech-trials@gene.com

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

Sites listed on ClinicalTrials.gov

16 listed

Prince of Wales Hospital — Randwick, New South Wales, Australia (recruiting)
St Vincent's Hospital Melbourne — Fitzroy, Victoria, Australia (recruiting)
CHU Lyon Sud - Service Hématologie — Pierre-Bénite, France (recruiting)
IUCT Oncopole — Toulouse, France (recruiting)
Hopital Bretonneau — Tours, France (recruiting)
IGR — Villejuif, France (withdrawn)
Universitätsklinikum Hamburg-Eppendorf Onkologisches Zentrum Medizinische Klinik II — Hamburg, Germany (recruiting)
Universitätsklinikum Leipzig - Klinik und Poliklinik für Hämatologie — Leipzig, Germany (recruiting)
Uniwersyteckie Centrum Kliniczne — Gda?sk, Poland (recruiting)
Szpital Kliniczny Ministerstwa Spraw Wewnetrznych i Administracji z Warminsko-Mazurskim Centrum Onkologii w Olsztynie — Olsztyn, Poland (recruiting)
Uniwersytecki Szpital Kliniczny w Poznaniu — Późna, Poland (withdrawn)
Severance Hospital, Yonsei University Health System — Seoul, South Korea (recruiting)

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FAQ about this NCT record

Is NCT05583617 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 NCT05583617?

Phase 1 / 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 NCT05583617?

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