Skip to content
Triangle logo TriangleGet started
← Full study record

NCT03710603 · OUTCOME

Determine the Incidence of Anti-daratumumab Antibodies (Immunogenicity) for All Subjects Who Receive at Least 1 Dose of Daratumumab and Determine the Incidence of Anti-rHuPH20 Antibodies

Daratumumab, VELCADE (Bortezomib), Lenalidomide and Dexamethasone Compared to VELCADE, Lenalidomide and Dexamethasone in Subjects With Previously Untreated Multiple Myeloma · Source last updated 2026-02-10

This outcome was registered, but no numerical results were posted in the captured record.

Measure
Not reported
Unit
Not reported
Interval / dispersion
Not reported
Time frame
From randomization to the clinical cutoff date. Maximum follow up was 54.41 months

What was measured

Immunogenicity of daratumumab serum samples will be screened for antibodies binding to daratumumab and serum titer will also be determined from confirmed positive samples using validated immunoassay methods. Other immunogenicity analyses (eg, assessment of neutralizing capabilities) may be performed to further characterize the immune responses that are generated. Plasma samples will be screened for antibodies binding to rHuPH20 and will be assessed in confirmatory and titer assays as necessary

Groups in this outcome

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Reported measurements

No numerical measurement classes were posted for this outcome. Missing is not zero.

Complete source fields
denom Units Selected
Participants
description
Immunogenicity of daratumumab serum samples will be screened for antibodies binding to daratumumab and serum titer will also be determined from confirmed positive samples using validated immunoassay methods. Other immunogenicity analyses (eg, assessment of neutralizing capabilities) may be performed to further characterize the immune responses that are generated. Plasma samples will be screened for antibodies binding to rHuPH20 and will be assessed in confirmatory and titer assays as necessary
reporting Status
NOT_POSTED
time Frame
From randomization to the clinical cutoff date. Maximum follow up was 54.41 months
title
Determine the Incidence of Anti-daratumumab Antibodies (Immunogenicity) for All Subjects Who Receive at Least 1 Dose of Daratumumab and Determine the Incidence of Anti-rHuPH20 Antibodies
type
SECONDARY

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice