Connect® MM- The Multiple Myeloma Disease Registry - Full Text View

Sponsor:	Celgene Corporation
Information provided by:	Celgene Corporation
ClinicalTrials.gov Identifier:	NCT01081028

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:

Genetics Home Reference related topics: aceruloplasminemia hemophilia

MedlinePlus related topics: Cancer Multiple Myeloma

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:	Kristen Sullivan, Study Manager, Celgene Corporation
ClinicalTrials.gov Identifier:	NCT01081028 History of Changes
Other Study ID Numbers:	Connect ® MM
Study First Received:	March 4, 2010
Last Updated:	June 13, 2011
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 February 09, 2012