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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02555839
Recruitment Status : Recruiting
First Posted : September 22, 2015
Last Update Posted : November 14, 2018
Information provided by (Responsible Party):

Brief 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.

Condition or disease Intervention/treatment
Multiple Myeloma Drug: Pomalidomide Drug: Dexamethasone

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.

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Study Type : Observational
Estimated Enrollment : 70 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Multicenter Non-interventional Study to Investigate Drug Utilization of Pomalidomide in Clinical Practice for the Treatment of Relapsed/Refractory Multiple Myeloma (rrMM)
Actual Study Start Date : March 1, 2015
Estimated Primary Completion Date : September 30, 2019
Estimated Study Completion Date : September 30, 2019

Group/Cohort Intervention/treatment
Pomalidomide and Dexamethasone
Pomalidomide 4mg capsules by mouth (PO) on days 1 though 21 of a 28 day cycle and Dexamethasone 40mg PO on Days 1, 8, 15, 22 of a 28 day cycle until progression or unacceptable toxicty
Drug: Pomalidomide
4mg capsules on Days 1 through 21 of a 28 day cycle
Other Names:
  • CC-4047
  • Imnovid

Drug: Dexamethasone
40mg by mouth on Days 1, 8, 15, 22 of a 28 day cycle
Other Name: Fortecortin

Primary Outcome Measures :
  1. Number of Adverse Events [ Time Frame: Up to 2 years ]
    The number of participant adverse events

Secondary Outcome Measures :
  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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Relapsed and/or Refractory Multiple Myeloma

Inclusion Criteria:

  1. Signed Informed Consent
  2. Age > 18 years
  3. Relapsed/refractory MM
  4. ≥2 antimyeloma treatments (Lenalidomide and Bortezomib)
  5. Refractory to last pre-treatment
  6. Adequate contraception according to monitoring plan
  7. Adequate thrombosis prophylaxis

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02555839

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Contact: Associate Director Clinical Trial Disclosure 1-888-260-1599

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LKH Feldkirch, Intern E, Hämatologie Recruiting
Feldkirch, Austria, 6800:
Medical University Graz Recruiting
Graz, Austria, 8036:
KH der Elisabethinen Linz , 1. Interne Hämato-Onkologie Recruiting
Linz, Austria, 4020:
SCRI-CCCIT gemeinnützige GmbH & Universitätsklinikum der PMU Salzburg Gemeinnützige Salzburger Landeskliniken BetriebsgmbH Recruiting
Salzburg, Austria, 5020:
LKH Steyr, Innere Medizin II Recruiting
Steyr, Austria, 4400
AKH, Innere Medizin I, Klin. Abt. f. Hämatologie Recruiting
Vienna, Austria, 1090:
AKH, Universitätsklinik für Innere Medizin I /Klin. Abteilung für Onkologie Recruiting
Vienna, Austria, 1090:
St. Josef Krankenhaus Wien,1. Abteilung für Innere Medizin Zentrum für Onkologie Recruiting
Vienna, Austria, 1130:
Hanusch Krankenhaus Wien 3. Medizinische Abteilung Hämatolog Not yet recruiting
Vienna, Austria, 1140:
Wilhelminenspital, 1. Med.Abteilung, Zentrum für Onkologie Not yet recruiting
Vienna, Austria, 1160:
Sponsors and Collaborators
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Study Chair: Guenter Voraberger, MD Celgene

Additional Information:
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Responsible Party: Celgene Identifier: NCT02555839     History of Changes
Other Study ID Numbers: CC-4047-MM-017
First Posted: September 22, 2015    Key Record Dates
Last Update Posted: November 14, 2018
Last Verified: November 2018

Keywords provided by Celgene:
Relapsed Multiple Myeloma
Refractory Multiple Myeloma

Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone acetate
BB 1101
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents