Relating Clinical Outcomes in Multiple Myeloma to Personal Assessment of Genetic Profile (CoMMpass)
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ClinicalTrials.gov Identifier: NCT01454297 |
Recruitment Status
:
Active, not recruiting
First Posted
: October 19, 2011
Last Update Posted
: September 27, 2016
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Condition or disease |
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Multiple Myeloma |
Study Type : | Observational |
Actual Enrollment : | 1154 participants |
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 |
Study Start Date : | July 2011 |
Estimated Primary Completion Date : | September 2023 |
Estimated Study Completion Date : | September 2023 |

Group/Cohort |
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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.
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- Molecular profiles and clinical characteristics that define subsets of myeloma patients at initial diagnosis and at relapse of disease. [ Time Frame: Baseline to 8 years. ]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.
- Response rates [ Time Frame: Up to one year after baseline. ]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 ]Progression-free survival and overall survival
- Bone disease assessed radiographically [ Time Frame: Baseline and during five to eight years of follow-up ]
- Health-related quality of life [ Time Frame: Baseline and during five to eight years of follow-up ]EORTC QLQ-C30 and QLQ-MY20
- Resource utilization [ Time Frame: Baseline and during five to eight years of follow-up ]Hospitalizations and ER visits
- Severe adverse events [ Time Frame: Five to eight years ]Severe/CTCAE grade 3-4 adverse events (checklist)
Biospecimen Retention: Samples With DNA

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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 |
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.

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): NCT01454297

Study Director: | Daniel Auclair | Multiple Myeloma Research Foundation |
Additional Information:
Responsible Party: | Multiple Myeloma Research Foundation |
ClinicalTrials.gov Identifier: | NCT01454297 History of Changes |
Other Study ID Numbers: |
MMRF-11-001 |
First Posted: | October 19, 2011 Key Record Dates |
Last Update Posted: | September 27, 2016 |
Last Verified: | August 2016 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | Interim Analysis data will be released every 6 months |
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 |