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Trial record 1 of 1 for:    NCT01081028
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Connect® MM- The Multiple Myeloma Disease Registry

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ClinicalTrials.gov Identifier: NCT01081028
Recruitment Status : Active, not recruiting
First Posted : March 5, 2010
Last Update Posted : December 22, 2017
Sponsor:
Information provided by (Responsible Party):
Celgene

Brief Summary:
The purpose of the Connect® MM Registry is to explore the natural history and real world management of patients with newly diagnosed symptomatic multiple myeloma (MM) and provide unique insights into the management of MM and the impact of this hematologic disorder on patients.

Condition or disease
Multiple Myeloma

Study Type : Observational
Actual Enrollment : 3011 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Connect® MM- The Multiple Myeloma Disease Registry
Study Start Date : September 1, 2009
Estimated Primary Completion Date : December 31, 2024
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma
U.S. FDA Resources

Group/Cohort
Group One: Patients enrolled between Sep2009 and Nov2011
Newly diagnosed multiple myeloma patients enrolled between Sep 2009 and Nov 2011.
Group Two: Patients enrolled between Dec2012 and mid-2016
Newly diagnosed multiple myeloma patients enrolled between Dec 2012 and mid-2016



Primary Outcome Measures :
  1. Identify and summarize patterns in therapeutic regimens [ Time Frame: Minimum 8 years ]
    Describe practice patterns of common first-line treatment regimens and subsequent therapeutic strategies in patients newly diagnosed with symptomatic MM in the community and academic setting

  2. Identify and summarize patterns in therapeutic regimens and patient outcomes [ Time Frame: Minimum 8 years ]
    Provide insight into treatment regimens and therapy sequence in clinical practice as they relate to clinical outcomes (response, overall survival, progression-free survival) in patients newly diagnosed with symptomatic MM


Secondary Outcome Measures :
  1. Summarize Effectiveness of Treatment Regimens [ Time Frame: Minimum 8 years ]
    Describe any differences in effectiveness associated with different treatment regimens, including common first-line regimens, subsequent therapeutic strategies and regional effects (such as proximity of academic centers) in patients newly diagnosed with symptomatic MM

  2. Summarize health-related quality of life (HRQoL) relation to treatment regimens/sequence and clinical outcomes [ Time Frame: Minimum 8 years ]
    Describe the health-related quality of life (HRQoL) of patients newly diagnosed with symptomatic MM, and to explore the association with HRQoL of treatment regimens/sequence and clinical outcomes



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with newly diagnosed multiple myeloma and being treated in community or academic settings in the United States
Criteria

Inclusion Criteria:

  • Newly diagnosed with symptomatic MM within 2 months of enrollment in Connect®MM registry
  • Age ≥18 years
  • Willing and able to provide signed informed consent
  • Agrees to complete patient assessment questionnaires either alone or with minimal assistance from caregivers and/or trained site personnel

Exclusion Criteria:

- None


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): NCT01081028


  Show 253 Study Locations
Sponsors and Collaborators
Celgene
Investigators
Study Director: Amit Agarwal, MD PhD Celgene Corporation

Publications:
Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT01081028     History of Changes
Other Study ID Numbers: Connect ® MM
First Posted: March 5, 2010    Key Record Dates
Last Update Posted: December 22, 2017
Last Verified: December 2017

Keywords provided by Celgene:
Multiple Myeloma
MM
disease registry
Connect®

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