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Completed

NCT Number: NCT02555839

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

LKH Feldkirch, Intern E, Hämatologie, Feldkirch, Austria

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About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Signed IC
  • age ≥ 18 years
  • relapsed/refractory MM
  • cohort A (combination pomalidomide und dexamethasone):

≥2 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):

≥1 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

Treatment and study plan

Pomalidomide

Drug

4mg capsule on d1 through 21 of a 28 day cycle

Other names: CC-4047, Imnovid

Dexamethasone

Drug

40 mg (≤75 years) or 20mg (>75 years) oral on d1, 8, 15, 22 of a 28 day cycle

Other names: Fortecortin

bortezomib

Drug

cycle 1-8: Bortezomib (1,3mg/m2) s.c. on day 1, 4, 8, 11 of a 21 day cycle; from cycle 9 onwards: Bortezomib (1,3mg/m2) s.c. on day 1 and 8 of a 21 day cycle,

Primary outcomes

  1. Number of Adverse Events

    Time frame: Up to 2 years

    The number of participant adverse events

Secondary outcomes

  1. Response Rate

    Time frame: Up to 2 years

    The number of participants who achieve a response

  2. Progression Free Survival

    Time frame: Up to 2 years

    The number of participants who survive without progression of disease

  3. Duration of Response

    Time frame: Up to 2 years

    Duration of response is defined as time from the initial documented response (partial response or better) to confirmed disease progression

Sponsors and collaborators

Lead sponsor

Celgene

Industry

Registry information

Official study title

Multicenter Non-interventional Study to Investigate Drug Utilization of Pomalidomide in Clinical Practice for the Treatment of Relapsed/Refractory Multiple Myeloma (rrMM)

Important dates

Study start
2015
Primary completion
2023
Study completion
2023
First posted
Sep 22, 2015
Registry last updated
Mar 28, 2025

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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