Multiple Myeloma Patient Registry

NCT03180853 | Terminated

• 2 other identifiers: CR108326NOPRODMMY4001
• Study Type: observational
• Target: 85
• Locations: 1 country
• Sites: 69

Brief 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 drug (IMiD) used either as monotherapy or combination therapy with other treatments.

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (7)

• 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.

  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.

  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).

  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).

  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.

  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.

  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.

  Up to 3 years

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Janssen Scientific Affairs, LLC: lead

Study Sites (69)

Arizona Oncology Associates, PC - HAL

Phoenix, Arizona, 85016, United States

Location

Mercy Research

Fort Smith, Arkansas, 72903-4100, United States

Location

Genesis Cancer Center

Hot Springs, Arkansas, 71913, United States

Location

St. Bernard's Medical Center

Jonesboro, Arkansas, 72401, United States

Location

CARTI

Little Rock, Arkansas, 72205, United States

Location

Facey Medical Group

Mission Hills, California, 91345, United States

Location

North County Oncology

Oceanside, California, 92056, United States

Location

Ventura County Hematology Oncology Specialists

Oxnard, California, 93030, United States

Location

James R. Berenson, MD Inc.

West Hollywood, California, 90069, United States

Location

PIH Health Hospital

Whittier, California, 90602, United States

Location

Rocky Mountain Cancer Centers

Denver, Colorado, 80218, United States

Location

University Cancer Institute (UCI)

Boynton Beach, Florida, 33426, United States

Location

Southeast Florida Hematology Oncology Group

Fort Lauderdale, Florida, 33308, United States

Location

Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

Location

Cancer Specialists of North Florida

Jacksonville, Florida, 32256, United States

Location

Watson Clinic Llp

Lakeland, Florida, 33805, United States

Location

Ocala Oncology Center

Ocala, Florida, 34471, United States

Location

Piedmont Cancer Institute

Atlanta, Georgia, 30318, United States

Location

Augusta University

Augusta, Georgia, 30912, United States

Location

Gwinnett Hospital System, Inc

Lawrenceville, Georgia, 30046, United States

Location

Nancy N. and J.C. Lewis Cancer & Research Pavillion -St. Josephs Candler Health System

Savannah, Georgia, 31405, United States

Location

Ingalls Memorial Hospital Cancer Research Center

Harvey, Illinois, 60426, United States

Location

Orchard Healthcare Research

Skokie, Illinois, 60077, United States

Location

Baptist Healthcare Systems, Inc. d/b/a Baptist Health Floyd

New Albany, Indiana, 47150, United States

Location

Physicians' Clinic of Iowa, P.C at PCI Main Building

Cedar Rapids, Iowa, 52403, United States

Location

Commonwealth Hematology-Oncology, P.C.

Danville, Kentucky, 40422, United States

Location

Hardin Memorial Hospital

Elizabethtown, Kentucky, 42701, United States

Location

Kentucky Cancer Care

Hazard, Kentucky, 41701, United States

Location

Oncology Associates of West Kentucky

Paducah, Kentucky, 42003, United States

Location

West Kentucky Hematology-Oncology

Paducah, Kentucky, 42003, United States

Location

Pontchartrain Cancer Center

Covington, Louisiana, 70433, United States

Location

Tulane University Hospital & Clinics

New Orleans, Louisiana, 70112, United States

Location

Mercy Medical Center

Baltimore, Maryland, 21202, United States

Location

Meritus Center for Clinical Research

Hagerstown, Maryland, 21742, United States

Location

Reliant Medical Group, Inc.

Worcester, Massachusetts, 01608, United States

Location

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

MidMichigan Health Cancer Center

Midland, Michigan, 48640, United States

Location

Providence Cancer Center

Southfield, Michigan, 48075, United States

Location

St. Luke's Speciality Clinic

Duluth, Minnesota, 55802, United States

Location

Singing River Health System

Pascagoula, Mississippi, 39581, United States

Location

Trinitas Comprehensive Cancer Center

Elizabeth, New Jersey, 07207, United States

Location

Southern Oncology Hematology Associates

Williamstown, New Jersey, 08360, United States

Location

North Shore Hematology Oncology Associates, P.C.

East Setauket, New York, 11733, United States

Location

Hudson Valley Hematology Oncology Associates

Poughkeepsie, New York, 12601, United States

Location

Community Health Network

Rochester, New York, 14620, United States

Location

Mid Ohio Oncology Hematology, DBA The Mark H. Zangmeister Center

Columbus, Ohio, 43219, United States

Location

Dayton Physicians, LLC

Kettering, Ohio, 45409, United States

Location

Good Samaritan Hospital Corvallis

Corvallis, Oregon, 97330, United States

Location

Abington Memorial Hospital

Abington, Pennsylvania, 19001, United States

Location

Lehigh Valley Health network (Oncology)

Bethlehem, Pennsylvania, 18015, United States

Location

Hematology and Oncology Associates of NEPA

Dunmore, Pennsylvania, 18512, United States

Location

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

Aria Health- Torresdale

Philadelphia, Pennsylvania, 19114, United States

Location

Charleston Cancer Center

Charleston, South Carolina, 29406, United States

Location

Carolina Blood and Cancer Care

Rock Hill, South Carolina, 29732, United States

Location

Wellmont Blue Ridge Medical Specialists

Bristol, Tennessee, 37620, United States

Location

Jackson Madison County General Hospital

Jacksonville, Tennessee, 38301, United States

Location

Texas Oncology P A

Arlington, Texas, 76012, United States

Location

Texas Oncology P A

Beaumont, Texas, 77702-1449, United States

Location

Texas Oncology P A

Denton, Texas, 76210, United States

Location

Texas Oncology P A

Flower Mound, Texas, 75028, United States

Location

Texas Oncology-Memorial City

Houston, Texas, 77024, United States

Location

Texas Oncology P A

Paris, Texas, 75460, United States

Location

Texas Oncology P A

Plano, Texas, 75075, United States

Location

Texas Oncology P A

Tyler, Texas, 75702, United States

Location

Texas Oncology P A

Waco, Texas, 76712, United States

Location

Texas Oncology P A

Webster, Texas, 77598, United States

Location

Texas Oncology P A

Wichita Falls, Texas, 76310, United States

Location

Kadlec Clinic Hematology & Oncology

Kennewick, Washington, 99336, United States

Location

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Janssen Scientific Affairs, LLC Clinical Trial

  Janssen Scientific Affairs, LLC

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2017
• First Posted: June 8, 2017
• Study Start: May 8, 2017
• Primary Completion: April 6, 2018
• Study Completion: April 6, 2018
• Last Updated: February 3, 2025

Record last verified: 2025-01

Locations

US (69)