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RecruitingPhase 1interventionalRules rewrite

Phase 1: testing Etentamig (ABBV-383) for Multiple Myeloma

Multiple Myeloma (MM) is a cancer of the blood's plasma cells ( blood cell). The cancer is typically found in the bones and bone marrow (the spongy tissue inside of the bones) and can cause bone pain, fractures, infections, weaker bones, and kidney failure.

Official registry: https://clinicaltrials.gov/study/NCT05650632 · AbbVie · enrollment listed as 250

What this phase means

Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched 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 Etentamig (ABBV-383). The registry lists allocation as randomized. Multiple Myeloma (MM) is a cancer of the blood's plasma cells ( blood cell).

They plan to enroll about 250 people at 44 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

A Multicenter, Phase 1b, Open-label Study to Evaluate Dose Optimization Measures and Safety of Etentamig (ABBV-383) in Subjects With Relapsed or Refractory Multiple Myeloma

Interventions: Etentamig (ABBV-383)

Primary outcome (registry wording): Arm A (Part 1 and Part 2) Arm C, Arm D, and Arm E: Number of Grade >= 2 Cytokine Release Syndrome (CRS) Events

Who it is for (from inclusion criteria)

  • Ages 18 Years to any
  • Must have measurable disease as outlined in the protocol
  • Eastern Cooperative Oncology Group (ECOG) performance of \<= 2. Arm C and Arm D: ECOG performance of \<= 1
  • Relapsed/refractory (R/R) multiple myeloma (MM) with documented evidence of progression during or after the participant's last treatment regimen based on the investigator's determination of the International Myeloma Working Group (IMWG) 2016 criteria
  • Must be naïve to treatment with etentamig (ABBV-383)
  • Arm A: Must have received at least 3 or more lines of therapy, including a proteasome inhibitor (PI), an immunomodulatory imide drug (IMiD), and an anti-CD38 monoclonal antibody
  • Arm C: Must have received at least 2 or more lines of therapy, including exposure to a PI, an IMiD, and an anti-CD38 monoclonal antibody. Must be suitable for outpatient administration of etentamig (ABBV-383)
  • Arm D: Must have received at least 1 and no more than 3 prior lines of therapy, including exposure to a PI, an IMiD, or an anti-CD38 monoclonal antibody. Must be suitable for outpatient administration of etentamig (ABBV-383)

Public study contact (from the registry)

ABBVIE CALL CENTER

844-663-3742

abbvieclinicaltrials@abbvie.com

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

Sites listed on ClinicalTrials.gov

44 listed

+ 19 sites outside the US on the same record

Related recruiting trials in this snapshot

RecruitingPhase 1La Jolla, California
Phase 1: testing Linvoseltamab for Multiple Myeloma

This study is researching an experimental drug called linvoseltamab in combination with other drugs for the treatment of a blood cancer called multiple myeloma. Linvoseltamab has previously been studied as a single agent (without other cancer treatments) in participants with multiple myeloma that returned after prior therapies and needed to be treated again.

NCT05137054 · Official ClinicalTrials.gov record · Regeneron Pharmaceuticals

FAQ about this NCT record

Is NCT05650632 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 NCT05650632?

Phase 1. 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 NCT05650632?

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