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A Post Authorisation Registry of IMNOVID (Pomalidomide) for Patients With Relapsed and Refractory Multiple Myeloma.

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ClinicalTrials.gov Identifier: NCT02164955
Recruitment Status : Recruiting
First Posted : June 17, 2014
Last Update Posted : December 7, 2018
Sponsor:
Information provided by (Responsible Party):
Celgene

Brief Summary:

This registry is a prospective, multi-center, observational study and will collect safety data on multiple myeloma adult patients who have received at least two prior therapies and take IMNOVID (pomalidomide) as part of standard care.

The registry will remain open until 500 patients will have received at least 3 cycles of pomalidomide. All patients registered will be followed up prospectively for up to 3 years following the end of pomalidomide treatment. During this time the incidence of second primary malignancies (SPM), overall survival and any occurrence of a pregnancy will be assessed.


Condition or disease Intervention/treatment
Multiple Myeloma Drug: IMNOVID

Study Type : Observational [Patient Registry]
Estimated Enrollment : 750 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: A Non-interventional Post Authorisation Registry of Patients Treated With Pomalidomide for Relapsed and Refractory Multiple Myeloma Who Have Received at Least Two Prior Treatment Regimens, Including Both Lenalidomide and Bortezomib, and Have Demonstrated Disease Progression on the Last Therapy
Actual Study Start Date : June 26, 2014
Estimated Primary Completion Date : August 31, 2022
Estimated Study Completion Date : August 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Group/Cohort Intervention/treatment
Relapsed and Refractory Multiple Myeloma Patients
Single Cohort of Relapsed and Refractory Multiple Myeloma Patients treated with IMNOVID (pomalidomide)
Drug: IMNOVID
IMNOVID (pomalidomide) as prescribed in routine clinical practice
Other Name: pomalidomide




Primary Outcome Measures :
  1. Determine incidence of risks as outlined in the Risk Management Plan [ Time Frame: Up to 5 years ]
    To characterize and determine the incidence of important identified and potential risks as outlined in the risk management plan (RMP) among previously treated multiple myeloma patients who are currently being treated with IMNOVID (pomalidomide) in a post-marketing setting.


Secondary Outcome Measures :
  1. Pregnancy Prevention Programme Effectiveness [ Time Frame: Up to 5 years ]
    To describe and assess the effectiveness, implementation and compliance of the Celgene Pregnancy Prevention Programme for patients recruited in this registry


Other Outcome Measures:
  1. Previous Treatments [ Time Frame: Approximately 6 months ]
    To describe the type of myeloma treatment administered immediately prior to receiving IMNOVID (pomalidomide).



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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
Patients with symptomatic, measurable relapsed and refractory multiple myeloma who have received at least two prior treatment regimens, including both bortezomib and lenalidomide and have demonstrated disease progression on the last therapy and are commencing a pomalidomide based treatment.
Criteria

Inclusion Criteria:

Understand and voluntarily sign an informed consent form, if applicable, and have never been previously treated with pomalidomide before their inclusion in the Registry.

Patients with symptomatic, measurable relapsed and refractory multiple myeloma who have received at least two prior treatment regimens, including both bortezomib and lenalidomide and have demonstrated disease progression on the last therapy and are commencing a pomalidomide based treatment.

Exclusion Criteria:

Refusal to participate in the Registry or currently participating in the treatment phase of an interventional clinical trial.

Pregnancy.

Women of childbearing potential, unless all the conditions of the pregnancy prevention program are met.

Male patients unable to follow or comply with the required contraceptive measures.

Hypersensitivity to the active substance or to any of the excipients.


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 ClinicalTrials.gov identifier (NCT number): NCT02164955


Contacts
Contact: Associate Director, Clinical Trial Disclosure 1-888-260-1599 clinicaltrialdisclosure@celgene.com

  Show 129 Study Locations
Sponsors and Collaborators
Celgene
Investigators
Study Director: Elisabeth Kueenburg, MD Celgene

Additional Information:
Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT02164955     History of Changes
Other Study ID Numbers: CC-4047-MM-015
First Posted: June 17, 2014    Key Record Dates
Last Update Posted: December 7, 2018
Last Verified: December 2018

Keywords provided by Celgene:
Pomalidomide
Multiple Myeloma
Relapsed, Refractory
Observational
Imnovid
Registry
Post-approval
Safety

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Pomalidomide
Thalidomide
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents
Immunosuppressive Agents
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents