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Connect® MM- The Multiple Myeloma Disease Registry

This study is currently recruiting participants.
Verified June 2011 by Celgene Corporation
Sponsor:
Information provided by (Responsible Party):
Celgene Corporation
ClinicalTrials.gov Identifier:
NCT01081028
First received: March 4, 2010
Last updated: April 9, 2012
Last verified: June 2011
History of Changes
  Purpose

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
Multiple Myeloma

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Connect® MM- The Multiple Myeloma Disease Registry

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Celgene Corporation:

Primary Outcome Measures:
  • Identify and summarize patterns in therapeutic regimens [ Time Frame: up to 8 years ] [ Designated as safety issue: No ]
    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

  • Identify and summarize patterns in therapeutic regimens and patient outcomes [ Time Frame: up to 8 years ] [ Designated as safety issue: No ]
    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:
  • Summarize Effectiveness of Treatment Regimens [ Time Frame: up to 8 years ] [ Designated as safety issue: No ]
    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

  • Summarize health-related quality of life (HRQoL) relation to treatment regimens/sequence and clinical outcomes [ Time Frame: up to 8 years ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 1500
Study Start Date: September 2009
Estimated Study Completion Date: September 2017
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with multiple myoloma and being treated in community or academic settings.

Criteria

Inclusion Criteria:

  • Newly diagnosed with symptomatic MM within 2 months of enrollment in Connect® MM registry
  • Age ≥18 years
  • Able to read and speak English
  • 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:

• Participation in a clinical study in which study treatment is blinded

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01081028

Contacts
Contact: Kristen Sullivan 1-913-266-0329 connectmm@celgene.com

  Show 253 Study Locations
Sponsors and Collaborators
Celgene Corporation
Investigators
Study Director: Mohamad Hussein, MD Celgene Corporation
  More Information

No publications provided

Responsible Party: Celgene Corporation
ClinicalTrials.gov Identifier: NCT01081028     History of Changes
Other Study ID Numbers: Connect ® MM
Study First Received: March 4, 2010
Last Updated: April 9, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Celgene Corporation:
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

ClinicalTrials.gov processed this record on May 16, 2013