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Completed

NCT Number: NCT01734928

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

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.

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Key information

Conditions

Multiple Myeloma Blood Protein Disorders Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hospital St. Polten, Sankt Pölten, Austria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pomalidomide

Drug

Pomalidomide 4 mg will be taken orally on Days 1-14 of a 21-day cycle.

Other names: Oral Pomalidomide, CC-4047

bortezomib

Drug

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.

Other names: Velcade

Dexamethasone

Drug

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.

Primary outcomes

  1. 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

    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.

Secondary outcomes

  1. Overall Survival (OS)

    Time frame: From randomization to date of death, up to approximately 65 months

    Overall survival (OS) is calculated as the time from randomization to death from any cause.

  2. 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

    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

  3. 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

    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

  4. 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

    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.

  5. 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

    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.

Sponsors and collaborators

Lead sponsor

Celgene

Industry

Registry information

Official study title

A Phase 3, Multicenter, Randomized, Open-Label Study to Compare the Efficacy and Safety of Pomalidomide, Bortezomib and Low-Dose Dexamethasone Versus Bortezomib and Low-Dose Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma

Acronym: OPTIMISMM

Important dates

Study start
2013
Primary completion
2022
Study completion
2022
First posted
Nov 28, 2012
Registry last updated
Jun 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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