NCT02375555 · OUTCOME

Best Responses to E-RVD.

Study of Bortezomib,Lenalidomide,Dexamethasone & Elotuzumab in Newly Diagnosed MM · Source last updated 2024-10-01

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure: COUNT_OF_PARTICIPANTS
Unit: Participants
Interval / dispersion: Not reported
Time frame: Participants were followed up to 273.6 weeks.

What was measured

Best responses to E-RVD was assessed using International Myeloma Working Group (IMWG) response criteria: Partial Response (PR) defined as 50% reduction of serum M-protein and reduction in 24h urinary M-protein by ≥90% or to \<200mg/24h; Very Good Partial Response (VGPR) defined as serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein plus urine M-protein level \<100mg/24h; Complete Response (CR) defined as negative immunofixation on serum and urine and, disappearance of any soft tissue plasmacytomas and, \<5% plasma cells in BM; Stringent Complete Response (sCR) defined as normal FLC ratio and absence of clonal cells in BM by immunohistochemistry or 2-4 color flow cytometry.

Analysis population: Best responses to E-RVD in the safety population, defined as participants with Multiple Myeloma who received one or more dose of elotuzumab. Out of the 40 participants included in the safety population, one participant did not receive or more dose of elotuzumab, and was not included in the best response analysis population.

Groups in this outcome

All Patients Treated With E-RVD (40 Patients).

Participants will receive therapy with the combination of lenalidomide, bortezomib, and dexamethasone and elotuzumab (E-RVD). Induction cycles (1 to 8) are 21-day cycles. * Elotuzumab will be administered by intravenous (IV) infusion * Bortezomib as a subcutaneous injection * Lenalidomide single daily oral dose * Dexamethasone as oral tablets and IV infusion * Stem cell mobilization will be performed for all subjects at the end of Cycle 4. Subjects may elect to stop E-RVD at the end of Cycle 4 and proceed to autologous SCT. Subjects who do not proceed to SCT may receive 8 cycles of induction therapy. The maintenance schedule (28 days) will start after 8 cycles of induction regimen for subjects not proceeding with SCT, or after recovery from SCT for subjects proceeding with it. Maintenance therapy with E-RVD will be administered to all patients, with the specific maintenance regimen determined by risk category.

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

Analysis denominator · Participants

Group	Source count
All Patients Treated With E-RVD (40 Patients).	39

Reported measurements

Source class 1

Sustained complete response (sCR)

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
All Patients Treated With E-RVD (40 Patients).	9	Not reported	Not reported	Not reported	Not reported

Complete response (CR)

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
All Patients Treated With E-RVD (40 Patients).	8	Not reported	Not reported	Not reported	Not reported

Very good partial response (VGPR)

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
All Patients Treated With E-RVD (40 Patients).	16	Not reported	Not reported	Not reported	Not reported

Partial response (PR)

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
All Patients Treated With E-RVD (40 Patients).	5	Not reported	Not reported	Not reported	Not reported

Minimal response (MR)

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
All Patients Treated With E-RVD (40 Patients).	1	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
9
title
Sustained complete response (sCR)
measurements
group Id
OG000
value
8
title
Complete response (CR)
measurements
group Id
OG000
value
16
title
Very good partial response (VGPR)
measurements
group Id
OG000
value
5
title
Partial response (PR)
measurements
group Id
OG000
value
1
title
Minimal response (MR)

denoms

counts
group Id
OG000
value
39
units
Participants

description

groups

description
Participants will receive therapy with the combination of lenalidomide, bortezomib, and dexamethasone and elotuzumab (E-RVD). Induction cycles (1 to 8) are 21-day cycles. * Elotuzumab will be administered by intravenous (IV) infusion * Bortezomib as a subcutaneous injection * Lenalidomide single daily oral dose * Dexamethasone as oral tablets and IV infusion * Stem cell mobilization will be performed for all subjects at the end of Cycle 4. Subjects may elect to stop E-RVD at the end of Cycle 4 and proceed to autologous SCT. Subjects who do not proceed to SCT may receive 8 cycles of induction therapy. The maintenance schedule (28 days) will start after 8 cycles of induction regimen for subjects not proceeding with SCT, or after recovery from SCT for subjects proceeding with it. Maintenance therapy with E-RVD will be administered to all patients, with the specific maintenance regimen determined by risk category.
id
OG000
title
All Patients Treated With E-RVD (40 Patients).

param Type

COUNT_OF_PARTICIPANTS

population Description

Best responses to E-RVD in the safety population, defined as participants with Multiple Myeloma who received one or more dose of elotuzumab. Out of the 40 participants included in the safety population, one participant did not receive or more dose of elotuzumab, and was not included in the best response analysis population.

reporting Status

POSTED

time Frame

Participants were followed up to 273.6 weeks.

title

Best Responses to E-RVD.

type

SECONDARY

unit Of Measure

Participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice