Clinical trial · Observational
Relating Clinical Outcomes in Multiple Myeloma to Personal Assessment of Genetic Profile
A Prospective, Longitudinal, Observational Study in Newly Diagnosed Multiple Myeloma (MM) Patients to Assess the Relationship Between Patient Outcomes, Treatment Regimens and Molecular Profiles
NCT01454297CI-TRIAL-00072683CoMMpasscompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- Newly diagnosed Multiple Myeloma
- description
- This is a prospective observational study in patients with symptomatic multiple myeloma who have not yet initiated therapy for their disease.
Primary outcomes (1)
- measure
- Molecular profiles and clinical characteristics that define subsets of myeloma patients at initial diagnosis and at relapse of disease.
- timeFrame
- Baseline to 8 years.
- description
- 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 outcomes (6)
- measure
- Response rates
- timeFrame
- Up to one year after baseline.
- description
- IMWG criteria: stringent complete response, complete response, very good partial response, partial response, no response.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (6)
- DERIVEDMeermeier EW, Missan DS, Pathangey LB, Stein CK, Reckard GA, Darvish SA, Ahmann GJ, Adamski J, Fonseca R, Gendler SJ, Gustafson MP, Bergsagel PL. Clinical Evaluation of Ex Vivo Expanded MUC1-Specific Peripheral Blood T Cells for Adoptive Immunotherapy in Relapsed/Refractory Multiple Myeloma. Cancer Res Commun. 2026 Jul 1;6(7):1592-1604. doi: 10.1158/2767-9764.CRC-25-0713. PMID 42274746
- DERIVEDOhlstrom DJ, Pilcher WC Jr, Michaud ME, Acharya C, Satpathy S, Gonzalez-Kozlova E, Jayasinghe RG, Ferguson K, Mumme HL, Nanda S, Song Y, Mantrala S, Karagkouni D, Schulman J, Pabustan N, Vieira Dos Santos J, Sherbenou DW, Keats JJ, Gout AM, Foltz S, Lagana A, Kourelis T, Vij R, Dhodapkar MV, Avigan D, Cho HJ, Baughn LB, Nooka AK, Lonial S, Kumar S, Samur MK, Vlachos IS, Ding L, Gnjatic S, Mulligan G, Bhasin MK. Longitudinal Profiling of Tumor and Immune Compartments Uncovers Patterns of Dysregulation and Associations with Response in Multiple Myeloma. Blood Cancer Discov. 2026 Mar 4;7(2):266-286. doi: 10.1158/2643-3230.BCD-25-0205. PMID 41364805
- DERIVEDAuclair D, Mansfield C, Fiala MA, Chari A, Cole CE, Kaufman JL, Orloff GJ, Siegel DS, Zonder JA, Mange B, Yesil J, Dalal M, Mikhael JR. Preferences and Priorities for Relapsed Multiple Myeloma Treatments Among Patients and Caregivers in the United States. Patient Prefer Adherence. 2022 Mar 1;16:573-585. doi: 10.2147/PPA.S345906. eCollection 2022. PMID 35256844
- DERIVEDBarwick BG, Gupta VA, Matulis SM, Patton JC, Powell DR, Gu Y, Jaye DL, Conneely KN, Lin YC, Hofmeister CC, Nooka AK, Keats JJ, Lonial S, Vertino PM, Boise LH. Chromatin Accessibility Identifies Regulatory Elements Predictive of Gene Expression and Disease Outcome in Multiple Myeloma. Clin Cancer Res. 2021 Jun 1;27(11):3178-3189. doi: 10.1158/1078-0432.CCR-20-2931. Epub 2021 Mar 17. PMID 33731366
- DERIVEDFoltz SM, Gao Q, Yoon CJ, Sun H, Yao L, Li Y, Jayasinghe RG, Cao S, King J, Kohnen DR, Fiala MA, Ding L, Vij R. Evolution and structure of clinically relevant gene fusions in multiple myeloma. Nat Commun. 2020 May 29;11(1):2666. doi: 10.1038/s41467-020-16434-y.