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

March 27, 2025 updated by: Celgene

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Actual)

127

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Feldkirch, Austria, 6800:
        • LKH Feldkirch, Intern E, Hämatologie
      • Graz, Austria, 8036:
        • Medical University Graz
      • Linz, Austria, 4020
        • Kepleruniversitätsklinikum GmbH, Hämatologie und Internistische Onkologie
      • Linz, Austria, 4020:
        • KH der Elisabethinen Linz , 1. Interne Hämato-Onkologie
      • Ried, Austria, 4910
        • Krankenhaus der Barmherzigen Schwestern Ried, Innere Medizin I
      • Salzburg, Austria, 5020:
        • SCRI-CCCIT gemeinnützige GmbH & Universitätsklinikum der PMU Salzburg Gemeinnützige Salzburger Landeskliniken BetriebsgmbH
      • Steyr, Austria, 4400
        • LKH Steyr, Innere Medizin II
      • Vienna, Austria, 1090:
        • AKH, Innere Medizin I, Klin. Abt. f. Hämatologie
      • Vienna, Austria, 1090:
        • AKH, Universitätsklinik für Innere Medizin I /Klin. Abteilung für Onkologie
      • Vienna, Austria, 1130:
        • St. Josef Krankenhaus Wien,1. Abteilung für Innere Medizin Zentrum für Onkologie
      • Vienna, Austria, 1140:
        • Hanusch Krankenhaus Wien 3. Medizinische Abteilung Hämatolog
      • Vienna, Austria, 1160:
        • Wilhelminenspital, 1. Med.Abteilung, Zentrum für Onkologie
      • Vöcklabruck, Austria, 4840
        • Salzkammergut-Klinikum Vöcklabruck, Abteilung Innere Medizin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Relapsed and/or Refractory Multiple Myeloma

Description

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:

  1. Pregnant or Lactating Females
  2. Known hypersensitivity to Imnovid

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Pomalidomide and Dexamethasone
Pomalidomide 4mg capsules by mouth (PO) on days 1 through 21 of a 28 day cycle and Dexamethasone 40mg PO (≤75 years) or 20mg (>75years) on Days 1, 8, 15, 22 of a 28 day cycle until progression or unacceptable toxicity
Drug: Pomalidomide
4mg capsule on d1 through 21 of a 28 day cycle
Other Names:
  • Imnovid
  • CC-4047
Drug: Dexamethasone
40 mg (≤75 years) or 20mg (>75 years) oral on d1, 8, 15, 22 of a 28 day cycle
Other Names:
  • Fortecortin
Drug: Pomalidomide
4mg capsule on d1 through 14 of a 21 day cycle
Drug: Dexamethasone
cycle 1-8: 20mg PO (≤75 years) or 10mg (>75years) on Days 1, 2, 4, 5, 8, 9, 11, 12 of a 21 day cycle; from cycle 9 onwards: Dexamethasone 20mg PO (≤75 years) or 10mg (>75years) on Days 1, 2, 8, 9 of a 21 day cycle
Pomalidomide, Bortezomib and Dexamethasone
Cycle 1-8: Pomalidomide 4mg capsules by mouth (PO) on days 1 through 14 of a 21 day cycle, Bortezomib (1,3mg/m2) s.c. on day 1, 4, 8, 11 of a 21 day cycle, and Dexamethasone 20mg PO (≤75 years) or 10mg (>75years) on Days 1, 2, 4, 5, 8, 9, 11, 12 of a 21 day cycle until progression or unacceptable toxicity; from cycle 9 onwards: Pomalidomide 4mg capsules by mouth (PO) on days 1 through 14 of a 21 day cycle, Bortezomib (1,3mg/m2) s.c. on day 1 and 8 of a 21 day cycle, and Dexamethasone 20mg PO (≤75 years) or 10mg (>75years) on Days 1, 2, 8, 9 of a 21 day cycle until progression or unacceptable toxicity
Drug: Pomalidomide
4mg capsule on d1 through 21 of a 28 day cycle
Other Names:
  • Imnovid
  • CC-4047
Drug: Dexamethasone
40 mg (≤75 years) or 20mg (>75 years) oral on d1, 8, 15, 22 of a 28 day cycle
Other Names:
  • Fortecortin
Drug: Pomalidomide
4mg capsule on d1 through 14 of a 21 day cycle
Drug: Dexamethasone
cycle 1-8: 20mg PO (≤75 years) or 10mg (>75years) on Days 1, 2, 4, 5, 8, 9, 11, 12 of a 21 day cycle; from cycle 9 onwards: Dexamethasone 20mg PO (≤75 years) or 10mg (>75years) on Days 1, 2, 8, 9 of a 21 day cycle
Drug: Bortezomib
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,

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Adverse Events
Time Frame: Up to 2 years
The number of participant adverse events
Up to 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Response Rate
Time Frame: Up to 2 years
The number of participants who achieve a response
Up to 2 years
Progression Free Survival
Time Frame: Up to 2 years
The number of participants who survive without progression of disease
Up to 2 years
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
Up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Celgene

Investigators

  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 20, 2015

Primary Completion (Actual)

June 30, 2023

Study Completion (Actual)

June 30, 2023

Study Registration Dates

First Submitted

September 18, 2015

First Submitted That Met QC Criteria

September 18, 2015

First Posted (Estimated)

September 22, 2015

Study Record Updates

Last Update Posted (Actual)

March 28, 2025

Last Update Submitted That Met QC Criteria

March 27, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CC-4047-MM-017

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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