Treatment of Relapsed/Refractory Multiple Myeloma (rrMM) With Pomalidomide in Clinical Practice

  • STATUS
    Recruiting
  • End date
    Sep 30, 2022
  • participants needed
    150
  • sponsor
    Celgene
Updated on 25 January 2021
maintenance therapy
induction therapy
dexamethasone
lenalidomide
bortezomib
refractory multiple myeloma
pomalidomide

Summary

There is a high unmet medical need for an anti-myeloma therapy for RRMM patients previously treated with Lenalidomide and Bortezomib, due to poor prognosis.

This observational study focuses on the collection of data concerning the safe and optimal usage of Pomalidomide, a new therapy option for RRMM patients, thereby increasing the knowledge about optimal AE management. Beside this, further analysis of tolerability, dosage and efficacy will be performed.

This knowledge could lead to a optimization of Pomalidomide usage and treatment.

Description

There is a high unmet medical need for further anti-myeloma therapy in patients with RRMM who have previously been treated with Lenalidomide and Bortezomib containing regimens that is both active and tolerable, as these patients have a poor prognosis. Hands-on experience with Pomalidomide is very limited in Austria and a non-interventional study enhances the attention paid to safe use and handling of the product as well as increase knowledge about optimal adverse event (AE) management substantially.

A detailed record of the medical history including. co-morbidities and pre-treatment regimens will allow analysis of the impact there of on tolerability, dosage and efficacy.

Beside the collection of data on efficacy and tolerability this observational drug utilization study could give insight into the clinical practice and the routine use of Pomalidomide.

Details
Condition Multiple Myeloma, Lymphoproliferative Disorder, Lymphoproliferative disorders, multiple myeloma (mm)
Treatment Pomalidomide, Dexamethasone, Bortezomib
Clinical Study IdentifierNCT02555839
SponsorCelgene
Last Modified on25 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Signed IC
age 18 years
relapsed/refractory MM
cohort A (combination pomalidomide und dexamethasone)
antimyeloma treatments (including lenalidomide and bortezomib), induction
therapy followed by ASCT and consolidation or maintenance therapy is
considered as 1 antimyeloma treatment
cohort B (combination pomalidomide, bortezomib and dexamethasone)
antimyeloma treatments (including lenalidomide) induction therapy followed
by ASCT and consolidation or maintenance therapy is considered as 1
antimyeloma treatment
refractory to last antimyeloma treatment
adequate contraception according to RMP
adequate thrombosis prophylaxis

Exclusion Criteria

Pregnant or Lactating Females
Known hypersensitivity to Imnovid
Clear my responses

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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