NCT01734928 · REGISTRY CONDITION SEARCH

Safety and Efficacy of Pomalidomide, Bortezomib and Low-dose Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE3
Status at capture: COMPLETED
Registry last update: 2023-06-06

The purpose of this study is to compare the efficacy of the combination of pomalidomide, bortezomib and low dose dexamethasone to the combination of bortezomib and low dose dexamethasone in participants with relapsed/refractory multiple myeloma. This study will also assess how safe the combination of pomalidomide, bortezomib and low dose dexamethasone is compared to the combination of bortezomib and low dose dexamethasone.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Progression Free Survival by Independent Response Adjudication Committee (IRAC)

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outcome · POSTED

Overall Survival (OS)

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outcome · POSTED

Overall Response Rate by Independent Response Adjudication Committee (IRAC)

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outcome · POSTED

Duration of Response by Independent Response Adjudication Committee (IRAC)

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outcome · POSTED

Number of Participants With Grade 3-4 Treatment Emergent Adverse Events (TEAE)

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outcome · POSTED

Number of Participants With Grade 5 Treatment Emergent Adverse Events (TEAE)

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility Criteria: Inclusion Criteria: * Must be ≥ 18 years at the time of signing informed consent. * Must have documented diagnosis of multiple myeloma and have measureable disease by serum and urine protein electrophoresis. * Must have had at least 1 but no greater than 3 prior anti-myeloma regimens. * Must have documented disease progression during or after their last anti-myeloma therapy. * All subjects must have received prior treatment with a lenalidomide containing regimen for at least 2 consecutive cycles. Exclusion Criteria: * Documented progressive disease during therapy or within 60 days of the last dose of a bortezomib-containing therapy under the 1.3 mg/m\^2 dose twice weekly dosing schedule. * Peripheral neuropathy Grade 3, Grade 4 or Grade 2 with pain within 14 days prior to randomization. * Non-secretory multiple myeloma. * Subjects with severe renal impairment requiring dialysis. * Previous therapy with pomalidomide.
healthy Volunteers: false
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
4 mg of Pomalidomide will be taken orally on Days 1-14 of a 21-day cycle along with 1.3 mg/m2 of Bortezomib administered subcutaneously on Days 1, 4, 8 and 11 of 21 days for cycles 1 -8 and on days 1, 8 of 21 days for cycle 9 and onward until disease progression, and Dexamethasone 20 mg/day \[≤ 75 years old\] or 10 mg/day \[\> 75 years old\] orally on days 1, 2, 4, 5, 8, 9, 11, 12 of 21 days for cycles 1-8 and on days 1, 2,8, 9 of 21 days for cycles 9 and onward until disease progression.
intervention Names
Drug: Pomalidomide
Drug: Bortezomib
Drug: Dexamethasone
label
Pomalidomide, Bortezomib and Low Dose Dexamethasone
type
EXPERIMENTAL
description
1.3 mg/m2 of Bortezomib will be administered subcutaneously on Days 1, 4, 8 and 11 of 21 days for cycles 1 -8 and on Days 1, 8 of 21 days for cycle 9 and onward until disease progression along with Dexamethasone 20 mg/day \[≤ 75 years old\]or 10 mg/day \[\> 75 years old\] orally on days 1, 2, 4, 5, 8, 9, 11, 12 of 21 days for cycles 1-8 and on Days 1, 2, 8, 9 of 21 days for cycles 9 and onward until disease progression.
intervention Names
Drug: Bortezomib
Drug: Dexamethasone
label
Bortezomib and Low Dose Dexamethasone
type
ACTIVE_COMPARATOR

interventions

arm Group Labels
Pomalidomide, Bortezomib and Low Dose Dexamethasone
description
Pomalidomide 4 mg will be taken orally on Days 1-14 of a 21-day cycle.
name
Pomalidomide
other Names
Oral Pomalidomide
CC-4047
type
DRUG
arm Group Labels
Bortezomib and Low Dose Dexamethasone
Pomalidomide, Bortezomib and Low Dose Dexamethasone
description
Bortezomib 1.3 mg/m2 will be administered subcutaneously on Days 1, 4, 8 and 11 of 21 days for cycles 1 -8 and on Days 1, 8 of 21 days for cycle 9 and onward until disease progression.
name
Bortezomib
other Names
Velcade
type
DRUG
arm Group Labels
Bortezomib and Low Dose Dexamethasone
Pomalidomide, Bortezomib and Low Dose Dexamethasone
description
Dexamethasone 20 mg/day \[≤ 75 years old\] or 10 mg/day \[\>75 years old\] will be taken orally on Days 1, 2, 4, 5, 8, 9, 11, 12 of 21 days for cycles 1-8 and on Days 1, 2, 8, 9 of 21 days for cycles 9 and onward until disease progression.
name
Dexamethasone
type
DRUG

Study design

allocation

RANDOMIZED

intervention Model

PARALLEL

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 559
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
Progression free survival (PFS) will be calculated as the time between the randomization and progressive disease (PD) or death. Progressive Disease is defined as an Increase of ≥ 25% from nadir in: * Serum M-component and/or (the absolute increase must be ≥ 0.5 g/dL)g * Urine M-component and/or (the absolute increase must be ≥ 200 mg/24 hours) * In patients without measurable serum and urine M-protein levels the difference between involved and uninvolved FLC levels, the absolute increase must be \> 100 mg/dL. * Bone marrow plasma cell percentage, the absolute % must be ≥ 10%h * Definite development of new bone lesions or soft tissue plasmacytomas increase in the size of existing bone lesions or soft tissue plasmacytomas. -Development of hypercalcemia (corrected serum calcium \> 11.5 mg/dL or 2.65 mmol/L) that can be attributed solely to the plasma cell proliferative disorder.
measure
Progression Free Survival by Independent Response Adjudication Committee (IRAC)
time Frame
From randomization to progressive disease or death during the IRAC assessment period, up to approximately 42 months

secondary Outcomes

description
Overall survival (OS) is calculated as the time from randomization to death from any cause.
measure
Overall Survival (OS)
time Frame
From randomization to date of death, up to approximately 65 months
description
The ORR together with the relative proportions in each response category (ie, stringent CR \[sCR\], CR, very good PR \[VGPR\], PR, SD, and PD) by treatment using the IMWG criteria will be examined. Complete Response: Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow SCR: CR+ Normal FLC ratio and Absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine Mprotein level \< 100 mg per 24 hours PR: ≥ 50% reduction of serum M-Protein and reduction in 24-hour urinary M-protein by ≥ 90% or to \< 200 mg per 24 hours Progressive Disease: Please refer to Primary outcome measure for definition SD: Not meeting criteria for CR, VGPR, PR, or progressive disease
measure
Overall Response Rate by Independent Response Adjudication Committee (IRAC)
time Frame
From randomization to progressive disease or death during the IRAC assessment period, up to approximately 42 months
description
Duration of myeloma response is defined as the duration from the time when the IMWG response criteria are first met for sCR or CR or VGPR or PR until the first date the response criteria are met for PD or until the subject died from any cause, whichever occurs first. Complete Response: Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow SCR: CR+ Normal FLC ratio and Absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine Mprotein level \< 100 mg per 24 hours PR: ≥ 50% reduction of serum M-Protein and reduction in 24-hour urinary M-protein by ≥ 90% or to \< 200 mg per 24 hours Progressive Disease: Please refer to Primary outcome measure for definition SD: Not meeting criteria for CR, VGPR, PR, or progressive disease
measure
Duration of Response by Independent Response Adjudication Committee (IRAC)
time Frame
From randomization to progressive disease or death during the IRAC assessment period, up to approximately 42 months
description
Treatment-emergent adverse events (TEAEs) are defined as any AE occurring or worsening on or after the first dose date of the study treatment and within 28 days after the last dose date.
measure
Number of Participants With Grade 3-4 Treatment Emergent Adverse Events (TEAE)
time Frame
From first dose to 28 days after the last dose (up to approximately 44 months
description
Treatment-emergent adverse events (TEAEs) are defined as any AE occurring or worsening on or after the first dose date of the study treatment and within 28 days after the last dose date.
measure
Number of Participants With Grade 5 Treatment Emergent Adverse Events (TEAE)
time Frame
From first dose to 28 days after the last dose (up to approximately 44 months

Full study description

brief Summary: The purpose of this study is to compare the efficacy of the combination of pomalidomide, bortezomib and low dose dexamethasone to the combination of bortezomib and low dose dexamethasone in participants with relapsed/refractory multiple myeloma. This study will also assess how safe the combination of pomalidomide, bortezomib and low dose dexamethasone is compared to the combination of bortezomib and low dose dexamethasone.

Source references

references

citation
Richardson PG, Oriol A, Beksac M, Liberati AM, Galli M, Schjesvold F, Lindsay J, Weisel K, White D, Facon T, San Miguel J, Sunami K, O'Gorman P, Sonneveld P, Robak P, Semochkin S, Schey S, Yu X, Doerr T, Bensmaine A, Biyukov T, Peluso T, Zaki M, Anderson K, Dimopoulos M; OPTIMISMM trial investigators. Pomalidomide, bortezomib, and dexamethasone for patients with relapsed or refractory multiple myeloma previously treated with lenalidomide (OPTIMISMM): a randomised, open-label, phase 3 trial. Lancet Oncol. 2019 Jun;20(6):781-794. doi: 10.1016/S1470-2045(19)30152-4. Epub 2019 May 13.
pmid
31097405
type
DERIVED
citation
Richardson PG, Hofmeister CC, Raje NS, Siegel DS, Lonial S, Laubach J, Efebera YA, Vesole DH, Nooka AK, Rosenblatt J, Doss D, Zaki MH, Bensmaine A, Herring J, Li Y, Watkins L, Chen MS, Anderson KC. Pomalidomide, bortezomib and low-dose dexamethasone in lenalidomide-refractory and proteasome inhibitor-exposed myeloma. Leukemia. 2017 Dec;31(12):2695-2701. doi: 10.1038/leu.2017.173. Epub 2017 Jun 2.
pmid
28642620
type
DERIVED