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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Celgene Corporation
Sponsor:
Information provided by (Responsible Party):
Celgene Corporation
ClinicalTrials.gov Identifier:
NCT01081028
First received: March 4, 2010
Last updated: December 31, 2013
Last verified: December 2013
  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:


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


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

  • Clinical practice [ 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


Estimated Enrollment: 3000
Study Start Date: September 2009
Estimated Study Completion Date: December 2023
Estimated Primary Completion Date: December 2023 (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
  • 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

  Show 281 Study Locations
Sponsors and Collaborators
Celgene Corporation
Investigators
Study Director: Yasir Nagarwala, 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: December 31, 2013
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 August 21, 2014