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NCT01441973 · ClinicalTrials.gov registry record · Phase 2

Biomarker Study of Elotuzumab in High Risk Smoldering Myeloma

A Phase 2 study, sponsored by Bristol-Myers Squibb.

Completed
Registry status
Phase 2
Development phase
41
Enrollment target

NCT01441973: Completed Phase 2 study, sponsored by Bristol-Myers Squibb.

NCT01441973 is a Phase 2 study that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 41 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (69% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01441973, a Phase 2 study, has completed, sponsored by Bristol-Myers Squibb.

COMPLETED
Registry status
Phase 2
Development phase
41 participants
Enrollment target

Study Summary

The purpose of this study is to determine whether elotuzumab will improve response in patients with high risk smoldering myeloma who have more CD56\^dim cells (a marker for the health of the body's immune system)

Primary Outcome

Estimated using linear regression model, with baseline CD56\^dim cells as the independent covariate, and maximal percent reduction in serum M protein as the dependent variable. For 1 patient who had nonmeasurable disease at baseline, the percent change in serum kappa-lambda difference was used instead of the percent change in serum M protein. Unit of measure=percent change from baseline in M protein cells/ percent change in CD56\^dim cells (% chg from BL in M pro/% chg CD56\^dim cs)

Interventions

  • BIOLOGICAL Elotuzumab (BMS-901608; HuLuc63)

Trial Details

FieldValue
Enrollment Target 41 participants
Start Date 2011-12-28
Est. Completion 2017-01-17
Phase Phase 2
Bristol-Myers Squibb

1,025 total trials

What the finished NCT01441973 record still lists

NCT01441973 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 41 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (69% lower).

The record links to 0 conditions, and to 1 intervention - of which Elotuzumab (BMS-901608; HuLuc63) is the first listed.

NCT01441973 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01441973 about?

NCT01441973 is a clinical study titled "Biomarker Study of Elotuzumab in High Risk Smoldering Myeloma". The purpose of this study is to determine whether elotuzumab will improve response in patients with high risk smoldering myeloma who have more CD56\^dim cells (a marker for the health of the body's immune system)

What is the current status of trial NCT01441973?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 41 participants. The study started on 2011-12-28. Estimated completion is 2017-01-17.

What interventions are being tested in trial NCT01441973?

The interventions under investigation include: Elotuzumab (BMS-901608; HuLuc63) (BIOLOGICAL).

Who is sponsoring clinical trial NCT01441973?

This trial is sponsored by Bristol-Myers Squibb, which has 1,025 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01441973's enrollment target sits among peer trials

41 1352nd of 2000 higher than 639 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01441973, the US trial registry maintained by the National Library of Medicine. NCT01441973 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.