NCT01049945 · OUTCOME

Dose Limiting Toxicity of Bendamustine Hydrochloride and Lenalidomide in Combination With Dexamethasone (Phase I)

Bendamustine Hydrochloride, Lenalidomide, and Dexamethasone in Treating Patients With Relapsed Multiple Myeloma · Source last updated 2020-02-11

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

Measure: NUMBER
Unit: Dose Limiting Toxic Events
Interval / dispersion: Not reported
Time frame: One cycle of treatment

What was measured

The Maximum Tolerated Dose (MTD) is the dose level below that at which a dose limiting toxicity (DLT) is observed in ≥ 33% (i.e., ≥ 2 of 6) subjects in a cohort. A dose limiting toxicity is defined as one of the following adverse events in the Common Terminology Criteria for Adverse Events (CTCAE) v 3.0 deemed at least possibly related to treatment: * Grade 2 neuropathy with pain * Any grade 3 Non-Hematologic toxicity * Any grade Non-Hematologic event requiring a dose reduction in cycle 1 or delaying the next cycle by \>14 days. * Grade 4 neutropenia * Febrile neutropenia * Grade 4 thrombocytopenia * Grade 3 thrombocytopenia associated with bleeding * Any Hematologic event requiring a dose reduction in cycle 1 or a delay in the next cycle of treatment by \>14 days. We are reporting the results of this endpoint as the number of DLTs per dose level.

Analysis population: All participants registered to the Phase I portion of this study were evaluable for this endpoint.

Groups in this outcome

Phase I, Dose Level 1

Bendamustine 50 mg/m\^2 IV day 1 Lenalidomide 15 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity

Phase I, Dose Level 2

Bendamustine 50 mg/m\^2 IV day 1 and 2 Lenalidomide 15 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity

Phase I, Dose Level 3

Bendamustine 75 mg/m\^2 IV day 1 and 2 Lenalidomide 15 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity

Phase I, Dose Level 4

Bendamustine 75 mg/m\^2 IV day 1 and 2 Lenalidomide 25 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity

Phase I, Dose Level 5

Bendamustine 100 mg/m\^2 IV day 1 and 2 Lenalidomide 25 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity

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
Phase I, Dose Level 1	3
Phase I, Dose Level 2	6
Phase I, Dose Level 3	3
Phase I, Dose Level 4	6
Phase I, Dose Level 5	3

Reported measurements

Source class 1

Values in Dose Limiting Toxic Events · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Phase I, Dose Level 1	0	Not reported	Not reported	Not reported	Not reported
Phase I, Dose Level 2	1	Not reported	Not reported	Not reported	Not reported
Phase I, Dose Level 3	0	Not reported	Not reported	Not reported	Not reported
Phase I, Dose Level 4	0	Not reported	Not reported	Not reported	Not reported
Phase I, Dose Level 5	2	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
0
group Id
OG001
value
1
group Id
OG002
value
0
group Id
OG003
value
0
group Id
OG004
value
2

denoms

counts
group Id
OG000
value
3
group Id
OG001
value
6
group Id
OG002
value
3
group Id
OG003
value
6
group Id
OG004
value
3
units
Participants

description

groups

description
Bendamustine 50 mg/m\^2 IV day 1 Lenalidomide 15 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity
id
OG000
title
Phase I, Dose Level 1
description
Bendamustine 50 mg/m\^2 IV day 1 and 2 Lenalidomide 15 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity
id
OG001
title
Phase I, Dose Level 2
description
Bendamustine 75 mg/m\^2 IV day 1 and 2 Lenalidomide 15 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity
id
OG002
title
Phase I, Dose Level 3
description
Bendamustine 75 mg/m\^2 IV day 1 and 2 Lenalidomide 25 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity
id
OG003
title
Phase I, Dose Level 4
description
Bendamustine 100 mg/m\^2 IV day 1 and 2 Lenalidomide 25 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity
id
OG004
title
Phase I, Dose Level 5

param Type

NUMBER

population Description

All participants registered to the Phase I portion of this study were evaluable for this endpoint.

reporting Status

POSTED

time Frame

One cycle of treatment

title

Dose Limiting Toxicity of Bendamustine Hydrochloride and Lenalidomide in Combination With Dexamethasone (Phase I)

type

PRIMARY

unit Of Measure

Dose Limiting Toxic Events

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Preserved source evidence · Not medical advice