Multiple MyelomaNCT03180853
Multiple Myeloma Patient Registry
An observational study of Multiple Myeloma, run by Janssen Scientific Affairs, LLC at 69 sites in United States.
Trial summary
The purpose of this study is to document the participants characteristics, disease burden, and clinical management of participants in the United States who are treated for relapsed multiple myeloma in routine medical practice with a treatment strategies that include a proteasome inhibitor (PI) and/or immunomodulatory… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- How many people
- 85 participants
- Where
- 69 sitesUnited States
- Study dates
- 8 May 2017to 6 Apr 2018
- 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: The participants to be enrolled in this registry will be participants whose multiple myeloma (MM) has relapsed after the administration of 1 to 3 prior lines of therapy and who initiate treatment with a proteasome inhibitor (PI) and/or immunomodulatory drug (IMiD) used either as monotherapy or combination therapy with other treatments within 90 days prior to study enrollment. Participants are to be recruited from medical centers in the United States.
Who may be able to join
- Must sign, and/or their legally acceptable representative where applicable must sign, a participation agreement/informed consent form (ICF) allowing data collection and source data verification in accordance with local requirements
- Have a diagnosis of relapsed MM [according to 2014 International Myeloma Working Group (IMWG) criteria] with 1 to 3 prior lines of therapy. (An induction regimen followed by autologous stem cell transplantation and single-agent maintenance therapy will be considered a single line of therapy.)
- Participants must have initiated a new line of induction therapy that includes a proteasome inhibitor (PI) and/or immunomodulatory drug (IMiD) within 90 days prior to enrollment. A short course of corticosteroids is allowed prior to initiating the new line of induction therapy
- Must be willing and able to complete the protocol-required patient-reported outcome (PROs)
Who cannot join
- Participant has plasma cell leukemia [greater than (>) 2.0 * 10^9 per liter] circulating plasma cells by standard differential), Waldenstrom's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, M-protein, and/or skin changes), or amyloid light-chain amyloidosis
- Participant has a life expectancy of less than 6 months
- At the time of screening, participant is enrolled in an interventional clinical trial for MM using an anti-neoplastic agent that is not currently approved by the United States (US) Food and Drug Administration (FDA)
Trial locations and contacts
69 sites in 1 country.
69 sites in 1 country
United States69 sites
Abington Memorial Hospital
Abington, Pennsylvania, 19001
Texas Oncology P A
Arlington, Texas, 76012
Piedmont Cancer Institute
Atlanta, Georgia, 30318
Augusta University
Augusta, Georgia, 30912
Mercy Medical Center
Baltimore, Maryland, 21202
Texas Oncology P A
Beaumont, Texas, 77702-1449
Lehigh Valley Health network (Oncology)
Bethlehem, Pennsylvania, 18015
University Cancer Institute (UCI)
Boynton Beach, Florida, 33426
Wellmont Blue Ridge Medical Specialists
Bristol, Tennessee, 37620
Physicians' Clinic of Iowa, P.C at PCI Main Building
Cedar Rapids, Iowa, 52403
Charleston Cancer Center
Charleston, South Carolina, 29406
Mid Ohio Oncology Hematology, DBA The Mark H. Zangmeister Center
Columbus, Ohio, 43219
Good Samaritan Hospital Corvallis
Corvallis, Oregon, 97330
Pontchartrain Cancer Center
Covington, Louisiana, 70433
Commonwealth Hematology-Oncology, P.C.
Danville, Kentucky, 40422
Texas Oncology P A
Denton, Texas, 76210
Rocky Mountain Cancer Centers
Denver, Colorado, 80218
Henry Ford Health System
Detroit, Michigan, 48202
St. Luke's Speciality Clinic
Duluth, Minnesota, 55802
Hematology and Oncology Associates of NEPA
Dunmore, Pennsylvania, 18512
North Shore Hematology Oncology Associates, P.C.
East Setauket, New York, 11733
Trinitas Comprehensive Cancer Center
Elizabeth, New Jersey, 07207
Hardin Memorial Hospital
Elizabethtown, Kentucky, 42701
Texas Oncology P A
Flower Mound, Texas, 75028
Southeast Florida Hematology Oncology Group
Fort Lauderdale, Florida, 33308
Mercy Research
Fort Smith, Arkansas, 72903-4100
Meritus Center for Clinical Research
Hagerstown, Maryland, 21742
Ingalls Memorial Hospital Cancer Research Center
Harvey, Illinois, 60426
Kentucky Cancer Care
Hazard, Kentucky, 41701
Genesis Cancer Center
Hot Springs, Arkansas, 71913
Texas Oncology-Memorial City
Houston, Texas, 77024
Mayo Clinic in Florida
Jacksonville, Florida, 32224
Cancer Specialists of North Florida
Jacksonville, Florida, 32256
Jackson Madison County General Hospital
Jacksonville, Tennessee, 38301
St. Bernard's Medical Center
Jonesboro, Arkansas, 72401
Kadlec Clinic Hematology & Oncology
Kennewick, Washington, 99336
Dayton Physicians, LLC
Kettering, Ohio, 45409
Watson Clinic Llp
Lakeland, Florida, 33805
Gwinnett Hospital System, Inc
Lawrenceville, Georgia, 30046
CARTI
Little Rock, Arkansas, 72205
MidMichigan Health Cancer Center
Midland, Michigan, 48640
Facey Medical Group
Mission Hills, California, 91345
Baptist Healthcare Systems, Inc. d/b/a Baptist Health Floyd
New Albany, Indiana, 47150
Tulane University Hospital & Clinics
New Orleans, Louisiana, 70112
Ocala Oncology Center
Ocala, Florida, 34471
North County Oncology
Oceanside, California, 92056
Ventura County Hematology Oncology Specialists
Oxnard, California, 93030
Oncology Associates of West Kentucky
Paducah, Kentucky, 42003
West Kentucky Hematology-Oncology
Paducah, Kentucky, 42003
Texas Oncology P A
Paris, Texas, 75460
Singing River Health System
Pascagoula, Mississippi, 39581
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
Aria Health- Torresdale
Philadelphia, Pennsylvania, 19114
Arizona Oncology Associates, PC - HAL
Phoenix, Arizona, 85016
Texas Oncology P A
Plano, Texas, 75075
Hudson Valley Hematology Oncology Associates
Poughkeepsie, New York, 12601
Community Health Network
Rochester, New York, 14620
Carolina Blood and Cancer Care
Rock Hill, South Carolina, 29732
Nancy N. and J.C. Lewis Cancer & Research Pavillion -St. Josephs Candler Health System
Savannah, Georgia, 31405
Orchard Healthcare Research
Skokie, Illinois, 60077
Providence Cancer Center
Southfield, Michigan, 48075
Texas Oncology P A
Tyler, Texas, 75702
Texas Oncology P A
Waco, Texas, 76712
Texas Oncology P A
Webster, Texas, 77598
James R. Berenson, MD Inc.
West Hollywood, California, 90069
PIH Health Hospital
Whittier, California, 90602
Texas Oncology P A
Wichita Falls, Texas, 76310
Southern Oncology Hematology Associates
Williamstown, New Jersey, 08360
Reliant Medical Group, Inc.
Worcester, Massachusetts, 01608
About this study
The purpose of this study is to document the participants characteristics, disease burden, and clinical management of participants in the United States who are treated for relapsed multiple myeloma in routine medical practice with a treatment strategies that include a proteasome inhibitor (PI) and/or immunomodulatory drug (IMiD) used either as monotherapy or combination therapy with other treatments.
- Conditions
- Multiple Myeloma
- Medical subject headings
- Multiple Myeloma
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 |
|---|---|---|
| Relapsed Multiple Myeloma Participants | The participants in the United States with a confirmed diagnosis of relapsed multiple myeloma following 1 to 3 prior lines of therapy who initiate treatment with a proteasome inhibitor (PI) and/or immunomodulatory drug (IMiD) used either as monotherapy or combination therapy with other treatments as per routine clinical practice within 90 days prior to study enrollment. These participants will be observed for the sequence of systemic myeloma treatments used during routine clinical practice, considering the life expectancy of patients with myeloma in the registry. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate
Overall response rate defined as the percentage of participants achieving Complete Response (CR), Very good partial response (VGPR), or Partial response (PR) (CR + VGPR + PR) as per International Myeloma Working Group (IMWG 2016) criteria. CR as negative immunofixation on serum and urine, disappearance of any soft tissue plasmacytomas and less than(<) 5 percent (%) plasma cells in bone marrow(BM). VGPR as serum and urine M-protein (monoclonal paraprotein) detectable by immunofixation but not on electrophoresis or 90% or greater than (>) reduction in serum and urine M-protein level <100 milligram (mg) per 24 hour (hr). PR as greater than or equal to (>=) 50% reduction of serum M-protein and less than (>=) 90% of urine M-protein or up to <200 mg per 24 hour.
Measured: Up to 3 years
Time to Next Treatment (TTNT)
TTNT is defined as the time from the date of initiation of regimen for induction to the initiation of next regimen for each successive therapy received.
Measured: Up to 3 years
Overall Survival (OS)
OS is defined as the time from the date of initiation of therapy to the date of death from any cause (or last documented follow-up).
Measured: Up to 3 years
Survival Time
Survival time is defined as the time from the start of each respective treatment to death (or last documented follow-up).
Measured: Up to 3 years
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Score
EORTC QLQ-C30 is a questionnaire to assess quality of life of cancer participants. It is composed of 30 items, multiitem measure (28 items) and 2 single-item measures. For the multiple item measure, 4 point scale is used and the score for each item range from "1 = not at all" to "4 = very much". Higher scores indicate worsening. The 2 single-item measure involves question about the overall health and overall quality of life which will be rated on a 7 point scale ranging from "1 = very poor" to "7 = excellent". Lower scores indicate worsening. Scores are averaged, and transformed to 0-100 scale; higher score=better level of physical functioning.
Measured: Up to 3 years
Katz Index of Independence for Activities of Daily Living
A standardized, validated tool that asks about independence in bathing, dressing, toileting, transferring, continence and feeding. The index having values from A to G. A indicates independence in all six functions and G indicates dependence in all six Functions.
Measured: Up to 3 years
Lawton Instrumental Activities of Daily Living
This questionnaire measures participants' abilities to do instrumental activities of daily living such as ability to use telephone, shopping, food preparation, housekeeping, laundry, mode of transportation, responsibilities of own medication and managing finances. The scale ranges from 0 to 8, a lower scale indicates higher level of dependence.
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2017
- Study start8 May 2017
- Primary completion6 Apr 2018
- Study completion6 Apr 2018
Why it stopped: Completion of study in orig timeframe not feasible considering evolving treatments for MM in US.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Scientific Affairs, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Scientific Affairs, LLC Clinical Trial, Study director, Janssen Scientific Affairs, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03180853
- Sponsor's protocol ID
- CR108326
- Other IDs
- NOPRODMMY4001
- Status last verified
- Jan 2025
- First submitted
- 6 Jun 2017
- Last updated
- 3 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multiple Myeloma Patient Registry
- ClinicalTrials.gov ID
- NCT03180853
- Acronym / sponsor ID
- CR108326
- Conditions
- Multiple Myeloma
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Completion of study in orig timeframe not feasible considering evolving treatments for MM in US.
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Janssen Scientific Affairs, LLCIndustry (pharma, biotech, devices)
- Study start
- 8 May 2017 (actual)
- Primary completion
- 6 Apr 2018 (actual)
- Study completion
- 6 Apr 2018 (actual)
- First posted
- 8 Jun 2017 (actual)
- 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 purpose of this study is to document the participants characteristics, disease burden, and clinical management of participants in the United States who are treated for relapsed multiple myeloma in routine medical practice with a treatment strategies that include a proteasome inhibitor (PI) and/or immunomodulatory drug (IMiD) used either as monotherapy or combination therapy with other treatments.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Relapsed Multiple Myeloma Participants | – | –The participants in the United States with a confirmed diagnosis of relapsed multiple myeloma following 1 to 3 prior lines of therapy who initiate treatment with a proteasome inhibitor (PI) and/or immunomodulatory drug (IMiD) used either as monotherapy or combination therapy with other treatments as per routine clinical practice within 90 days prior to study enrollment. These participants will be observed for the sequence of systemic myeloma treatments used during routine clinical practice, considering the life expectancy of patients with myeloma in the registry. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The participants to be enrolled in this registry will be participants whose multiple myeloma (MM) has relapsed after the administration of 1 to 3 prior lines of therapy and who initiate treatment with a proteasome inhibitor (PI) and/or immunomodulatory drug (IMiD) used either as monotherapy or combination therapy with other treatments within 90 days prior to study enrollment. Participants are to be recruited from medical centers in the United States.
Key inclusion criteria (4 listed)
- Must sign, and/or their legally acceptable representative where applicable must sign, a participation agreement/informed consent form (ICF) allowing data collection and source data verification in accordance with local requirements
- Have a diagnosis of relapsed MM [according to 2014 International Myeloma Working Group (IMWG) criteria] with 1 to 3 prior lines of therapy. (An induction regimen followed by autologous stem cell transplantation and single-agent maintenance therapy will be considered a single line of therapy.)
- Participants must have initiated a new line of induction therapy that includes a proteasome inhibitor (PI) and/or immunomodulatory drug (IMiD) within 90 days prior to enrollment. A short course of corticosteroids is allowed prior to initiating the new line of induction therapy
- Must be willing and able to complete the protocol-required patient-reported outcome (PROs)
Key exclusion criteria (3 listed)
- Participant has plasma cell leukemia [greater than (>) 2.0 * 10^9 per liter] circulating plasma cells by standard differential), Waldenstrom's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, M-protein, and/or skin changes), or amyloid light-chain amyloidosis
- Participant has a life expectancy of less than 6 months
- At the time of screening, participant is enrolled in an interventional clinical trial for MM using an anti-neoplastic agent that is not currently approved by the United States (US) Food and Drug Administration (FDA)
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
Overall Response Rate
Time frame: Up to 3 years
Overall response rate defined as the percentage of participants achieving Complete Response (CR), Very good partial response (VGPR), or Partial response (PR) (CR + VGPR + PR) as per International Myeloma Working Group (IMWG 2016) criteria. CR as negative immunofixation on serum and urine, disappearance of any soft tissue plasmacytomas and less than(<) 5 percent (%) plasma cells in bone marrow(BM). VGPR as serum and urine M-protein (monoclonal paraprotein) detectable by immunofixation but not on electrophoresis or 90% or greater than (>) reduction in serum and urine M-protein level <100 milligram (mg) per 24 hour (hr). PR as greater than or equal to (>=) 50% reduction of serum M-protein and less than (>=) 90% of urine M-protein or up to <200 mg per 24 hour.
Time to Next Treatment (TTNT)
Time frame: Up to 3 years
TTNT is defined as the time from the date of initiation of regimen for induction to the initiation of next regimen for each successive therapy received.
Overall Survival (OS)
Time frame: Up to 3 years
OS is defined as the time from the date of initiation of therapy to the date of death from any cause (or last documented follow-up).
Survival Time
Time frame: Up to 3 years
Survival time is defined as the time from the start of each respective treatment to death (or last documented follow-up).
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Score
Time frame: Up to 3 years
EORTC QLQ-C30 is a questionnaire to assess quality of life of cancer participants. It is composed of 30 items, multiitem measure (28 items) and 2 single-item measures. For the multiple item measure, 4 point scale is used and the score for each item range from "1 = not at all" to "4 = very much". Higher scores indicate worsening. The 2 single-item measure involves question about the overall health and overall quality of life which will be rated on a 7 point scale ranging from "1 = very poor" to "7 = excellent". Lower scores indicate worsening. Scores are averaged, and transformed to 0-100 scale; higher score=better level of physical functioning.
Katz Index of Independence for Activities of Daily Living
Time frame: Up to 3 years
A standardized, validated tool that asks about independence in bathing, dressing, toileting, transferring, continence and feeding. The index having values from A to G. A indicates independence in all six functions and G indicates dependence in all six Functions.
Lawton Instrumental Activities of Daily Living
Time frame: Up to 3 years
This questionnaire measures participants' abilities to do instrumental activities of daily living such as ability to use telephone, shopping, food preparation, housekeeping, laundry, mode of transportation, responsibilities of own medication and managing finances. The scale ranges from 0 to 8, a lower scale indicates higher level of dependence.
Results and safety
The study was stopped early (reason given: Completion of study in orig timeframe not feasible considering evolving treatments for MM in US.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2025.
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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.
Janssen Scientific Affairs, LLC Clinical Trial study director
Janssen Scientific Affairs, LLC
69 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Myeloma, run by Janssen Scientific Affairs, LLC at 69 sites in United States.
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 4 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: stopped early, as of the sponsor's last update on 3 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 69 sites in United States. 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 was stopped early (reason given: Completion of study in orig timeframe not feasible considering evolving treatments for MM in US.). Results are not available in the source record.
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?
Overall Response Rate (time frame: Up to 3 years). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Feb 2025.