Relating Clinical Outcomes in Multiple Myeloma to Personal Assessment of Genetic Profile (CoMMpass)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Multiple Myeloma Research Foundation
Sponsor:
Collaborators:
Translational Genomics Research Institute, Phoenix, Arizona.
Spectrum Health Hospitals
Van Andel Research Institute
Information provided by (Responsible Party):
Multiple Myeloma Research Foundation
ClinicalTrials.gov Identifier:
NCT01454297
First received: October 7, 2011
Last updated: June 26, 2014
Last verified: June 2014
  Purpose

The primary objective of this observational study is to identify the molecular profiles and clinical characteristics that define subsets of myeloma patients during the course of the disease.


Condition
Multiple Myeloma

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective, Longitudinal, Observational Study in Newly Diagnosed Multiple Myeloma (MM) Patients to Assess the Relationship Between Patient Outcomes, Treatment Regimens and Molecular Profiles

Resource links provided by NLM:


Further study details as provided by Multiple Myeloma Research Foundation:

Primary Outcome Measures:
  • Molecular profiles and clinical characteristics that define subsets of myeloma patients at initial diagnosis and at relapse of disease. [ Time Frame: Baseline to 5years. ] [ Designated as safety issue: No ]
    Standard clinical and laboratory assessments. Genomic tests (DNA and RNA sequencing, etc.) on bone marrow aspirates obtained at baseline, suspected complete response, and relapse/progression.


Secondary Outcome Measures:
  • Response rates [ Time Frame: Up to one year after baseline. ] [ Designated as safety issue: No ]
    IMWG criteria: stringent complete response, complete response, very good partial response, partial response, no response.

  • Survival rates [ Time Frame: Five to eight years after baseline ] [ Designated as safety issue: No ]
    Progression-free survival and overall survival

  • Bone disease assessed radiographically [ Time Frame: Baseline and during five to eight years of follow-up ] [ Designated as safety issue: No ]
  • Health-related quality of life [ Time Frame: Baseline and during five to eight years of follow-up ] [ Designated as safety issue: No ]
    EORTC QLQ-C30 and QLQ-MY20

  • Resource utilization [ Time Frame: Baseline and during five to eight years of follow-up ] [ Designated as safety issue: No ]
    Hospitalizations and ER visits

  • Severe adverse events [ Time Frame: Five to eight years ] [ Designated as safety issue: Yes ]
    Severe/CTCAE grade 3-4 adverse events (checklist)


Biospecimen Retention:   Samples With DNA

Bone marrow, Peripheral Blood


Estimated Enrollment: 1000
Study Start Date: July 2011
Estimated Study Completion Date: July 2019
Estimated Primary Completion Date: July 2019 (Final data collection date for primary outcome measure)
Groups/Cohorts
Newly diagnosed Multiple Myeloma
This is a prospective observational study in patients with symptomatic multiple myeloma who have not yet initiated therapy for their disease.

Detailed Description:

Understanding the molecular basis of cancer is a critical step toward devising the most effective treatment of the patient as an individual. The promise of molecular targeted therapeutics and personalized cancer care has been demonstrated in breast and lung cancer and chronic myeloid leukemia. However, similar examples of success in multiple myeloma have not been achieved despite extensive basic research as well as clinical advances. What is well understood is that myeloma is a heterogeneous disease with great genetic and epigenetic complexity.22, 23 Therefore, there remains a critical need to understand myeloma patient biology in the context of current patient care.24 The objective of this longitudinal study is to identify patient subgroups and phenotypes defined by molecular profiling and clinical features. These profiles will enable a better understanding of mechanisms of disease, drug response and patient relapse. Ultimately the study is intended to drive successful drug development and patient care in multiple myeloma.

  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

Newly diagnosed, symptomatic, multiple myeloma, candidates for systemic treatment

Criteria

Inclusion Criteria:

  • Patient is at least 18 years old.
  • Patient has been diagnosed with symptomatic MM with measurable disease that includes at least one of the following:

Serum M protein ≥ 1g/dl Urine M protein ≥ 200 mg/24 hrs Involved free light chain level ≥ 10 mg/dl and an abnormal serum free light chain ratio (<0.26 or >1.65).

  • The patient is a candidate for systemic therapy that includes an IMiD® (e.g., lenalidomide, pomalidomide, thalidomide) and/or proteasome inhibitor (e.g., bortezomib, carfilzomib) as part of the initial regimen.
  • No more than 30 days from baseline bone marrow evaluation as per this protocol to initiation of first-line therapy.
  • Patient has read, understood and signed informed consent.

Exclusion Criteria:

  • Patient is already receiving systemic therapy for MM (a single dose of bisphosphonates and up to 100 mg total dose of dexamethasone or equivalent corticosteroids are permitted prior to registration on study).
  • Patient had another malignancy within the last 5 years (except for basal or squamous cell carcinoma, or in situ cancer of the cervix).
  • Patient is enrolled in a blinded clinical trial for the first-line treatment of multiple myeloma. Patients may be enrolled in subsequent clinical trials as long as continued access to data and tissue, as per this protocol, is not prohibited.
  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: NCT01454297

Contacts
Contact: Beverly Harrison 203 652 0213 Harrisonb@themmrf.org
Contact: CoMMpass Contact Center CoMMpass@themmrf.org

  Show 86 Study Locations
Sponsors and Collaborators
Multiple Myeloma Research Foundation
Translational Genomics Research Institute, Phoenix, Arizona.
Spectrum Health Hospitals
Van Andel Research Institute
Investigators
Study Director: Beverly Harrison, BS Multiple Myeloma Research Foundation
  More Information

Additional Information:
No publications provided

Responsible Party: Multiple Myeloma Research Foundation
ClinicalTrials.gov Identifier: NCT01454297     History of Changes
Other Study ID Numbers: MMRF-11-001
Study First Received: October 7, 2011
Last Updated: June 26, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Multiple Myeloma Research Foundation:
Myeloma
Multiple Myeloma
Observational
Longitudinal

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 July 26, 2014