NCT01712789 · REGISTRY CONDITION SEARCH

Evaluation of Safety of Pomalidomide in Combination With Dexamethasone (Low Dose) in Patients With Refractory or Relapsed and 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: 2022-01-10

The primary purpose of the study is to evaluate the safety and efficacy and to generate PK and biomarker data for the combination of pomalidomide and low-dose dexamethasone in patients with refractory or relapsed and refractory multiple myeloma. The study consists of a Screening phase within 28 days prior to cycle 1 day 1, a Treatment phase and a Follow-up phase which starts within 28 days of discontinuation from study treatment, every 3 months for up to 5 years. In addition, the collection of steady-state PK data from a large population will enable robust population PK and assess Pomalidomide exposure response analyses. The exploratory objectives of the study are to investigate potential markers predictive of POM response or resistance and pharmacodynamic markers.

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

Number of Participants With Treatment Emergent Adverse Events (TEAE)

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outcome · POSTED

Overall Response

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outcome · POSTED

Time to Response

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outcome · POSTED

Kaplan Meier Estimate of Duration of Response

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outcome · POSTED

Kaplan Meier Estimate of Progression Free Survival (PFS) According to the European Medicines Agency Guidelines

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outcome · POSTED

Kaplan Meier Estimate of Time to Progression

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outcome · POSTED

Kaplan Meier Estimate of Overall Survival (OS)

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outcome · POSTED

Pomalidomide Exposure - Apparent (Oral) Clearance (CL/F)

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outcome · POSTED

Pomalidomide Exposure - Apparent Volume of Distribution (V/F)

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outcome · POSTED

Cytogenetic Analysis

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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: * Patients ≥18 years old, who must understand and voluntarily sign an Informed Consent. * Patients must have documented diagnosis of Multiple Myeloma and have measurable disease. * Patients must have undergone prior treatment with ≥ 2 treatments lines, of anti-myeloma therapy. * Patients must have either refractory or relapsed and refractory disease. * Patients must have received at least 2 consecutive cycles of prior treatment that include lenalidomide and bortezomib, either alone or in combination regimens. * Patients must have received adequate alkylator therapy Exclusion Criteria: * Prior history of malignancies, other than Multiple Myeloma. * Previous therapy with Pomalidomide, hypersensitivity to thalidomide and lenalidomide or dexamethasone. * Patients who received an allogeneic bone marrow or allogeneic peripheral blood stem cell transplant. * Patients who are planning for or who are eligible for stem cell transplant. * Patients who received major surgery and any anti-myeloma drug therapy within the last 14 days of starting study treatment. * Patients with a current disease that can interfere with protocol procedures or study treatment. * Patients unable or unwilling to undergo antithrombotic prophylactic treatment. * Pregnant or breastfeeding females.
healthy Volunteers: false
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
Pomalidomide 4mg by mouth (PO) daily days 1 through 21 of a 28 day cycle and dexamethasone 40mg/day PO for those ≤75 years of age or 20mg/day for those greater than 75 years of age on Days 1, 8, 15 and 22 of a 28 day cycle.
intervention Names
Drug: Pomalidomide
Drug: Dexamethasone
label
Pomalidomide plus Dexamethasone
type
EXPERIMENTAL

interventions

arm Group Labels
Pomalidomide plus Dexamethasone
description
Oral Pomalidomide at the starting dose of 4 mg on Days 1-21 of a 28-day cycle
name
Pomalidomide
type
DRUG
arm Group Labels
Pomalidomide plus Dexamethasone
description
Oral Low dose Dexamethasone at the starting dose of 40mg/day (≤ 75 years old) or 20 mg/day (\> 75 years old) on Days 1, 8, 15 and 22 of a 28-day cycle.
name
Dexamethasone
type
DRUG

Study design

allocation

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 682
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
An adverse event (AE) is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a subject during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the subject's health, regardless of etiology. Any worsening (i.e., any significant adverse change in the frequency or intensity of a pre- existing condition) was considered an AE. The severity of AEs were graded based on the symptoms according to version 4.0 of the National Cancer Institute Common Terminology Criteria for Adverse Events. Second primary malignancies were monitored as events of interest and considered as part of the assessment of AEs. A SAE = AE occurring at any dose that: * Results in death; * Is life-threatening * Requires inpatient hospitalization or prolongation of existing hospitalization * Results in persistent or significant disability/incapacity * Is a congenital anomaly/birth defect
measure
Number of Participants With Treatment Emergent Adverse Events (TEAE)
time Frame
From the first dose of study treatment up to 28 days following the last dose of study treatment. The median duration of treatment with pomalidomide and LD-dex was 21.4 weeks.

secondary Outcomes

description
Overall response rate (ORR) was defined as the percentage of participants with a stringent complete response (sCR), complete response (CR), very good partial response (VGPR) or partial response (PR) according to the International Myeloma Working Group uniform response criteria (IMWG URC) assessed by the Investigator. Responses must have been confirmed at at least 2 consecutive assessments before the institution of any new therapy with no known evidence of progressive or new bone lesions
measure
Overall Response
time Frame
Response was assessed at each treatment cycle and at treatment discontinuation; median duration of treatment with pomalidomide and LD-dex was 21.4 weeks
description
Time to response was defined as the time from treatment enrollment to the first documentation of response (sCR, CR, VGPR or PR) based on IMWG criteria.
measure
Time to Response
time Frame
Response was assessed at each treatment cycle and at treatment discontinuation; median duration of treatment with pomalidomide and LD-dex was 21.4 weeks
description
Duration of response, calculated for responders only, was defined as time from the initial documented response (SCR, CR, VGPR or PR) to the first confirmed disease progression, or death if no disease progression was recorded. Participants without a documented progression were censored at the time of their last tumor assessment.
measure
Kaplan Meier Estimate of Duration of Response
time Frame
From enrollment to the end of follow-up; median time on follow-up was 10.9 (range 0 - 81) months
description
Progression free survival was calculated as the time from study enrollment, defined as the IVRS enrollment date, until either PD or death (any cause). Participants without an event (either a documented PD or death) at the time of study end were censored at the time of their last documented disease assessment or at the IVRS enrollment date if no disease assessment was conducted.
measure
Kaplan Meier Estimate of Progression Free Survival (PFS) According to the European Medicines Agency Guidelines
time Frame
From enrollment to the end of follow-up; median time on follow-up was 10.9 (range 0 - 81) months
description
Time to progression was calculated as the time from study enrollment until first recorded disease progression as determined by the site investigator based on the IMWG criteria, or until death due to progression. Participants not experiencing a documented progression were censored at the time of their last tumor assessment (or at the time of trial enrollment if no assessment was conducted).
measure
Kaplan Meier Estimate of Time to Progression
time Frame
From enrollment to the end of follow-up; median time on follow-up was 10.9 (range 0 - 81) months
description
Overall survival was calculated as the time from study enrollment, defined as the IVRS enrollment date, until death due to any cause. Participants who did not have death data at the time of study end/analysis were censored at the time they were last known to be alive.
measure
Kaplan Meier Estimate of Overall Survival (OS)
time Frame
From enrollment to the end of follow-up; median time on follow-up was 10.9 (range 0 - 81) months
description
Pharmacokinetic (PK) parameters are derived from pomalidomide concentration versus time data.
measure
Pomalidomide Exposure - Apparent (Oral) Clearance (CL/F)
time Frame
Cycles 1, 2, 3, 4, 5, 6
description
Pharmacokinetic (PK) parameters are derived from Pomalidomide concentration versus time data.
measure
Pomalidomide Exposure - Apparent Volume of Distribution (V/F)
time Frame
Cycles 1, 2, 3, 4, 5, 6
description
Cytogenetic analysis was to be performed using fluorescence in situ hybridization (FISH) methodology at a local laboratory, to evaluate the relationship between cytogenetic profiles and the combination of POM and LD-DEX in terms of response and outcome.
measure
Cytogenetic Analysis
time Frame
Study entry

Full study description

brief Summary: The primary purpose of the study is to evaluate the safety and efficacy and to generate PK and biomarker data for the combination of pomalidomide and low-dose dexamethasone in patients with refractory or relapsed and refractory multiple myeloma. The study consists of a Screening phase within 28 days prior to cycle 1 day 1, a Treatment phase and a Follow-up phase which starts within 28 days of discontinuation from study treatment, every 3 months for up to 5 years. In addition, the collection of steady-state PK data from a large population will enable robust population PK and assess Pomalidomide exposure response analyses. The exploratory objectives of the study are to investigate potential markers predictive of POM response or resistance and pharmacodynamic markers.

Source references

references

citation
Dimopoulos MA, Palumbo A, Corradini P, Cavo M, Delforge M, Di Raimondo F, Weisel KC, Oriol A, Hansson M, Vacca A, Blanchard MJ, Goldschmidt H, Doyen C, Kaiser M, Petrini M, Anttila P, Cafro AM, Raymakers R, San-Miguel J, de Arriba F, Knop S, Rollig C, Ocio EM, Morgan G, Miller N, Simcock M, Peluso T, Herring J, Sternas L, Zaki MH, Moreau P. Safety and efficacy of pomalidomide plus low-dose dexamethasone in STRATUS (MM-010): a phase 3b study in refractory multiple myeloma. Blood. 2016 Jul 28;128(4):497-503. doi: 10.1182/blood-2016-02-700872. Epub 2016 May 25.
pmid
27226434
type
BACKGROUND
citation
Moreau P, Dimopoulos MA, Richardson PG, Siegel DS, Cavo M, Corradini P, Weisel K, Delforge M, O'Gorman P, Song K, Chen C, Bahlis N, Oriol A, Hansson M, Kaiser M, Anttila P, Raymakers R, Joao C, Cook G, Sternas L, Biyukov T, Slaughter A, Hong K, Herring J, Yu X, Zaki M, San-Miguel J. Adverse event management in patients with relapsed and refractory multiple myeloma taking pomalidomide plus low-dose dexamethasone: A pooled analysis. Eur J Haematol. 2017 Sep;99(3):199-206. doi: 10.1111/ejh.12903. Epub 2017 Jun 14.
pmid
28504846
type
BACKGROUND
citation
Qian X, Dimopoulos MA, Amatangelo M, Bjorklund C, Towfic F, Flynt E, Weisel KC, Ocio EM, Yu X, Peluso T, Sternas L, Zaki M, Moreau P, Thakurta A. Cereblon gene expression and correlation with clinical outcomes in patients with relapsed/refractory multiple myeloma treated with pomalidomide: an analysis of STRATUS. Leuk Lymphoma. 2019 Feb;60(2):462-470. doi: 10.1080/10428194.2018.1485915. Epub 2018 Aug 2.
pmid
30068263
type
BACKGROUND
citation
Siegel DS, Weisel KC, Dimopoulos MA, Baz R, Richardson P, Delforge M, Song KW, San Miguel JF, Moreau P, Goldschmidt H, Cavo M, Jagannath S, Yu X, Hong K, Sternas L, Zaki M, Palumbo A. Pomalidomide plus low-dose dexamethasone in patients with relapsed/refractory multiple myeloma and moderate renal impairment: a pooled analysis of three clinical trials. Leuk Lymphoma. 2016 Dec;57(12):2833-2838. doi: 10.1080/10428194.2016.1177181. Epub 2016 Jun 7.
pmid
27267105
type
BACKGROUND

Source notices and limitations

Discovery and provenance

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Preserved source evidence · Not medical advice