Multiple MyelomaCoMMpassNCT01454297
Relating Clinical Outcomes in Multiple Myeloma to Personal Assessment of Genetic Profile
An observational study of Multiple Myeloma, run by Multiple Myeloma Research Foundation at 73 sites in 3 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- How many people
- 1,154 participants
- Where
- 73 sitesin 3 countries
- Study dates
- Jul 2011to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Newly diagnosed, symptomatic, multiple myeloma, candidates for systemic treatment
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
73 sites in 3 countries.
73 sites in 3 countries
United States55 sites
Winship Cancer Institute - Emory University
Atlanta, Georgia, 30322
Billings Clinic
Billings, Montana, 59101
Waverly Hematology Oncology
Cary, North Carolina, 27518
Levine Cancer Institute
Charlotte, North Carolina, 28204
University of Chicago
Chicago, Illinois, 60637
Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
Baylor Research Institute
Dallas, Texas, 75246
University of Texas Southwest Medical Center
Dallas, Texas, 75390
Atlanta VA Medical Center
Decatur, Georgia, 30033
Kaiser Permanente of Colorado
Denver, Colorado, 80205
Rocky Mountain Cancer Centers
Denver, Colorado, 80218
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201
Duke University Hospital
Durham, North Carolina, 27710
Virginia Cancer Specialists PV
Fairfax, Virginia, 22013
Grand Rapids Clinical Oncology Program
Grand Rapids, Michigan, 49503
East Carolina University
Greenville, North Carolina, 27834
Hackensack University Medical Center
Hackensack, New Jersey, 07601
University of Mississippi Medical Center
Jackson, Mississippi, 39216
Broome Oncology
Johnson City, New York, 13790
Kansas City VA Medical Center
Kansas City, Missouri, 64128
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03784
Saint Barnabas Medical Center
Livingston, New Jersey, 07039
Marshfield Clinic
Marshfield, Wisconsin, 54449
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
New York University Medical Center
New York, New York, 10016
Mt Sinai Medical Center
New York, New York, 10029
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Weill Cornell Medical College-NY Presbyterian Hospital
New York, New York, 10065
Illinois Cancer Specialists
Niles, Illinois, 60714
Ocala Oncology Center
Ocala, Florida, 34471
University of Nebraska Medical Center
Omaha, Nebraska, 68198
First Health Outpatient Cancer Center
Pinehurst, North Carolina, 28374
Oregon Health and Science University
Portland, Oregon, 97239
Mayo Clinic-Rochester
Rochester, Minnesota, 55905
St Francis Hospital
Roslyn, New York, 11576
Peninsula Regional Cancer Center
Salisbury, Maryland, 21801
Cancer Care Centers of South Texas
San Antonio, Texas, 78217
UC San Diego Moores Cancer Center
San Diego, California, 92093
Sharp Health Care
San Diego, California, 92123
VA San Diego Healthcare System
San Diego, California, 92161
San Francisco VA Medical Center
San Francisco, California, 94121
UCSF Medical Center
San Francisco, California, 94143
Mayo Clinic Campus in Scottsdale, AZ
Scottsdale, Arizona, 85259
Holy Cross Hospital
Silver Spring, Maryland, 20902
Cancer Care Northwest
Spokane, Washington, 99202
Washington University
St Louis, Missouri, 63110
Carl and Dorothy Bennett Cancer Center
Stamford, Connecticut, 06907
Central Texas VA Healthcare Center
Temple, Texas, 76504
Eastchester Center for Cancer Care
The Bronx, New York, 10469
Northwest Cancer Specialists, PC
Tualatin, Oregon, 97062
Texas Oncology - Tyler
Tyler, Texas, 75702
Texas Oncology- Waco
Waco, Texas, 76712
VA Medical Center, Washington DC,
Washington D.C., District of Columbia, 20422
Cancer Center of Kansas
Wichita, Kansas, 67214
Yakima Valley Memorial Hospital/North Star Lodge
Yakima, Washington, 98902
Spain14 sites
H. U. Germans Trias i Pujol
Badalona, Catalonia, 08916
Hospital del Mar
Barcelona, 08003
Hospital Santa Creu I Sant Pau
Barcelona, 08026
Hospital Clinic i Provincial
Barcelona, 08036
Hospital Ramón y Cajal
Madrid, 28034
Hospital Puerta de Hierro
Madrid, 28222
Hospital Univ Son Espases
Palma de Mallorca, Balearic Islands, 07120
Hospital Son Llàtze
Palma de Mallorca, Balearic Islands, 07198
Clínica Universitaria de Navarra
Pamplona, Navarre, 31008
Hospital Quirón de Madrid
Pozuelo de Alarcón, Madrid, 28223
Hospital University de Salamanca
Salamanca, Castille and León, 37007
University Hospital Infanta Sofia
San Sebastián de los Reyes, Madrid, 28702
Hospital Universitari de Canarias
Santa Cruz de Tenerife, Santa Cruz, 38320
Hospital Clinica Universitari Lozano Blesa
Zaragoza, Aragon, 50012
Canada4 sites
Tom Baker Cancer Centre, Alberta Health Services
Calgary, Alberta, T2N 2T9
Cross Cancer Institute, Alberta Health Services
Edmonton, Alberta, T6G 1Z2
McGill University Health Center, Royal Victoria Hospital
Montreal, Quebec, H3A1A1
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9
About this study
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
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.
Read the 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.
- Conditions
- Multiple Myeloma
- Keywords
- Myeloma, Multiple Myeloma, Observational, Longitudinal
- Medical subject headings
- Multiple Myeloma, Neoplasms, Plasma Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Molecular profiles and clinical characteristics that define subsets of myeloma patients at initial diagnosis and at relapse of disease.
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.
Measured: Baseline to 8 years.
Secondary outcomes (6)
Response rates
IMWG criteria: stringent complete response, complete response, very good partial response, partial response, no response.
Measured: Up to one year after baseline.
Survival rates
Progression-free survival and overall survival
Measured: Five to eight years after baseline
Bone disease assessed radiographically
Measured: Baseline and during five to eight years of follow-up
Health-related quality of life
EORTC QLQ-C30 and QLQ-MY20
Measured: Baseline and during five to eight years of follow-up
Resource utilization
Hospitalizations and ER visits
Measured: Baseline and during five to eight years of follow-up
Severe adverse events
Severe/CTCAE grade 3-4 adverse events (checklist)
Measured: Five to eight years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2011 (estimated)
- Study startJul 2011
- Primary completion30 Nov 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,154 participants (actual)
Sponsor and investigators
- Lead sponsor
- Multiple Myeloma Research Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Translational Genomics Research Institute, Corewell Health West, Van Andel Research Institute
- Responsible party
- Sponsor
- Investigators
- Daniel Auclair, Study director, Multiple Myeloma Research Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01454297
- Sponsor's protocol ID
- MMRF-11-001
- Acronym
- CoMMpass
- Status last verified
- Jan 2024
- First submitted
- 7 Oct 2011
- Last updated
- 3 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Interim Analysis data will be released every 6 months
Publications
Meermeier 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.
PubMed 42274746Ohlstrom 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.
PubMed 41364805Akkus E, Tuncali T, Akin HY, Beksac M. Somatic variants and frequencies of familial myeloma germline predisposition genes among patients within the CoMMpass dataset. Expert Rev Hematol. 2026 Jan;19(1):79-88. doi: 10.1080/17474086.2025.2567299. Epub 2025 Oct 3.
PubMed 40996854Auclair 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.
PubMed 35256844Barwick 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.
PubMed 33731366Foltz 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.
PubMed 32471990Miller A, Asmann Y, Cattaneo L, Braggio E, Keats J, Auclair D, Lonial S; MMRF CoMMpass Network; Russell SJ, Stewart AK. High somatic mutation and neoantigen burden are correlated with decreased progression-free survival in multiple myeloma. Blood Cancer J. 2017 Sep 22;7(9):e612. doi: 10.1038/bcj.2017.94.
PubMed 28937974
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01454297
- Acronym / sponsor ID
- CoMMpass / MMRF-11-001
- Conditions
- Multiple Myeloma
- Keywords
- Myeloma, Multiple Myeloma, Observational, Longitudinal
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,154 participants (actual)
- Lead sponsor
- Multiple Myeloma Research FoundationUniversity, hospital or other
- Collaborators
- Translational Genomics Research Institute, Corewell Health West, Van Andel Research Institute
- Study start
- Jul 2011 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 19 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Newly diagnosed, symptomatic, multiple myeloma, candidates for systemic treatment
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
6 secondary outcomes
Response rates
Time frame: Up to one year after baseline.
Survival rates
Time frame: Five to eight years after baseline
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
Resource utilization
Time frame: Baseline and during five to eight years of follow-up
Severe adverse events
Time frame: Five to eight years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2024.
- Derived from this study: PubMed 42274746Meermeier 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.
- Derived from this study: PubMed 41364805Ohlstrom 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.
- Derived from this study: PubMed 40996854Akkus E, Tuncali T, Akin HY, Beksac M. Somatic variants and frequencies of familial myeloma germline predisposition genes among patients within the CoMMpass dataset. Expert Rev Hematol. 2026 Jan;19(1):79-88. doi: 10.1080/17474086.2025.2567299. Epub 2025 Oct 3.
- Derived from this study: PubMed 35256844Auclair 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.
- Derived from this study: PubMed 33731366Barwick 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.
- Derived from this study: PubMed 32471990Foltz 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.
- Derived from this study: PubMed 28937974Miller A, Asmann Y, Cattaneo L, Braggio E, Keats J, Auclair D, Lonial S; MMRF CoMMpass Network; Russell SJ, Stewart AK. High somatic mutation and neoantigen burden are correlated with decreased progression-free survival in multiple myeloma. Blood Cancer J. 2017 Sep 22;7(9):e612. doi: 10.1038/bcj.2017.94.
- The Multiple Myeloma Research FoundationLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Interim Analysis data will be released every 6 months
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Auclair study director
Multiple Myeloma Research Foundation
73 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Myeloma, run by Multiple Myeloma Research Foundation at 73 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 73 sites in United States, Spain, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01454297, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2024.