Multiple Myeloma Patient Registry

January 31, 2025 updated by: Janssen Scientific Affairs, LLC
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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
85

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85016
        • Arizona Oncology Associates, PC - HAL
    • Arkansas
      • Fort Smith, Arkansas, United States, 72903-4100
        • Mercy Research
      • Hot Springs, Arkansas, United States, 71913
        • Genesis Cancer Center
      • Jonesboro, Arkansas, United States, 72401
        • St. Bernard's Medical Center
      • Little Rock, Arkansas, United States, 72205
        • CARTI
    • California
      • Mission Hills, California, United States, 91345
        • Facey Medical Group
      • Oceanside, California, United States, 92056
        • North County Oncology
      • Oxnard, California, United States, 93030
        • Ventura County Hematology Oncology Specialists
      • West Hollywood, California, United States, 90069
        • James R. Berenson, MD Inc.
      • Whittier, California, United States, 90602
        • PIH Health Hospital
    • Colorado
      • Denver, Colorado, United States, 80218
        • Rocky Mountain Cancer Centers
    • Florida
      • Boynton Beach, Florida, United States, 33426
        • University Cancer Institute (UCI)
      • Fort Lauderdale, Florida, United States, 33308
        • Southeast Florida Hematology Oncology Group
      • Jacksonville, Florida, United States, 32256
        • Cancer Specialists of North Florida
      • Jacksonville, Florida, United States, 32224
        • Mayo Clinic in Florida
      • Lakeland, Florida, United States, 33805
        • Watson Clinic LLP
      • Ocala, Florida, United States, 34471
        • Ocala Oncology Center
    • Georgia
      • Atlanta, Georgia, United States, 30318
        • Piedmont Cancer Institute
      • Augusta, Georgia, United States, 30912
        • Augusta University
      • Lawrenceville, Georgia, United States, 30046
        • Gwinnett Hospital System, Inc
      • Savannah, Georgia, United States, 31405
        • Nancy N. and J.C. Lewis Cancer & Research Pavillion -St. Josephs Candler Health System
    • Illinois
      • Harvey, Illinois, United States, 60426
        • Ingalls Memorial Hospital Cancer Research Center
      • Skokie, Illinois, United States, 60077
        • Orchard Healthcare Research
    • Indiana
      • New Albany, Indiana, United States, 47150
        • Baptist Healthcare Systems, Inc. d/b/a Baptist Health Floyd
    • Iowa
      • Cedar Rapids, Iowa, United States, 52403
        • Physicians' Clinic of Iowa, P.C at PCI Main Building
    • Kentucky
      • Danville, Kentucky, United States, 40422
        • Commonwealth Hematology-Oncology, P.C.
      • Elizabethtown, Kentucky, United States, 42701
        • Hardin Memorial Hospital
      • Hazard, Kentucky, United States, 41701
        • Kentucky Cancer Care
      • Paducah, Kentucky, United States, 42003
        • Oncology Associates of West Kentucky
      • Paducah, Kentucky, United States, 42003
        • West Kentucky Hematology-Oncology
    • Louisiana
      • Covington, Louisiana, United States, 70433
        • Pontchartrain Cancer Center
      • New Orleans, Louisiana, United States, 70112
        • Tulane University Hospital & Clinics
    • Maryland
      • Baltimore, Maryland, United States, 21202
        • Mercy Medical Center
      • Hagerstown, Maryland, United States, 21742
        • Meritus Center for Clinical Research
    • Massachusetts
      • Worcester, Massachusetts, United States, 01608
        • Reliant Medical Group, Inc.
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Health System
      • Midland, Michigan, United States, 48640
        • MidMichigan Health Cancer Center
      • Southfield, Michigan, United States, 48075
        • Providence Cancer Center
    • Minnesota
      • Duluth, Minnesota, United States, 55802
        • St. Luke's Speciality Clinic
    • Mississippi
      • Pascagoula, Mississippi, United States, 39581
        • Singing River Health System
    • New Jersey
      • Elizabeth, New Jersey, United States, 07207
        • Trinitas Comprehensive Cancer Center
      • Williamstown, New Jersey, United States, 08360
        • Southern Oncology Hematology Associates
    • New York
      • East Setauket, New York, United States, 11733
        • North Shore Hematology Oncology Associates, P.C.
      • Poughkeepsie, New York, United States, 12601
        • Hudson Valley Hematology Oncology Associates
      • Rochester, New York, United States, 14620
        • Community Health Network
    • Ohio
      • Columbus, Ohio, United States, 43219
        • Mid Ohio Oncology Hematology, DBA The Mark H. Zangmeister Center
      • Kettering, Ohio, United States, 45409
        • Dayton Physicians, LLC
    • Oregon
      • Corvallis, Oregon, United States, 97330
        • Good Samaritan Hospital Corvallis
    • Pennsylvania
      • Abington, Pennsylvania, United States, 19001
        • Abington Memorial Hospital
      • Bethlehem, Pennsylvania, United States, 18015
        • Lehigh Valley Health network (Oncology)
      • Dunmore, Pennsylvania, United States, 18512
        • Hematology and Oncology Associates of NEPA
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University Hospital
      • Philadelphia, Pennsylvania, United States, 19114
        • Aria Health- Torresdale
    • South Carolina
      • Charleston, South Carolina, United States, 29406
        • Charleston Cancer Center
      • Rock Hill, South Carolina, United States, 29732
        • Carolina Blood and Cancer Care
    • Tennessee
      • Bristol, Tennessee, United States, 37620
        • Wellmont Blue Ridge Medical Specialists
      • Jacksonville, Tennessee, United States, 38301
        • Jackson Madison County General Hospital
    • Texas
      • Arlington, Texas, United States, 76012
        • Texas Oncology P A
      • Beaumont, Texas, United States, 77702-1449
        • Texas Oncology P A
      • Denton, Texas, United States, 76210
        • Texas Oncology P A
      • Flower Mound, Texas, United States, 75028
        • Texas Oncology P A
      • Houston, Texas, United States, 77024
        • Texas Oncology-Memorial City
      • Paris, Texas, United States, 75460
        • Texas Oncology P A
      • Plano, Texas, United States, 75075
        • Texas Oncology P A
      • Tyler, Texas, United States, 75702
        • Texas Oncology P A
      • Waco, Texas, United States, 76712
        • Texas Oncology P A
      • Webster, Texas, United States, 77598
        • Texas Oncology P A
      • Wichita Falls, Texas, United States, 76310
        • Texas Oncology P A
    • Washington
      • Kennewick, Washington, United States, 99336
        • Kadlec Clinic Hematology & Oncology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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 the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Up to 3 years
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.
Up to 3 years
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).
Up to 3 years
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).
Up to 3 years
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.
Up to 3 years
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.
Up to 3 years
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.
Up to 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Janssen Scientific Affairs, LLC

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Janssen Scientific Affairs, LLC Clinical Trial, Janssen Scientific Affairs, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 8, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 6, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 6, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 6, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 6, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 8, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 31, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CR108326
  • NOPRODMMY4001 (Other Identifier: Janssen Scientific Affairs, LLC)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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