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A Study of Real-life Current Standards of Care in Patients With Relapsed and/or Refractory Multiple Myeloma Who Received at Least 3 Prior Lines of Therapy Including Proteasome Inhibitor (PI), Immunomodulatory Drug (IMID), and Cluster of Differentiation 38 (CD38) Monoclonal Antibody Treatment (LocoMMotion)

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ClinicalTrials.gov Identifier: NCT04035226
Recruitment Status : Recruiting
First Posted : July 29, 2019
Last Update Posted : October 17, 2019
Sponsor:
Collaborator:
Legend Biotech
Information provided by (Responsible Party):
Janssen-Cilag Ltd.

Brief Summary:
The purpose of this study is to assess the safety and clinical response including overall response rate (ORR) of real-life standard-of-care (SOC) treatments under routine clinical practice, over a 24-month period, in patients with relapsed/refractory multiple myeloma (RRMM).

Condition or disease Intervention/treatment
Multiple Myeloma Other: No intervention

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Study Type : Observational
Estimated Enrollment : 230 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective, Multinational Study of Real-life Current Standards of Care in Patients With Relapsed and/or Refractory Multiple Myeloma Who Received at Least 3 Prior Lines of Therapy Including PI, IMID, and CD38 Monoclonal Antibody Treatment
Actual Study Start Date : August 2, 2019
Estimated Primary Completion Date : April 28, 2022
Estimated Study Completion Date : April 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Group/Cohort Intervention/treatment
Relapsed/refractory Multiple Myeloma
Patients with relapsed/refractory multiple myeloma who received at least 3 prior lines of therapy including Proteasome Inhibitor (PI), Immunomodulatory Drug (IMID), and Cluster of Differentiation 38 (CD38) Monoclonal Antibody treatment will be observed.
Other: No intervention
No intervention will be administered as a part of this study.




Primary Outcome Measures :
  1. Overall Response Rate (ORR) [ Time Frame: Up to 24 months ]
    ORR is defined as the percentage of patients who achieve a partial response (PR) or better according to the international myeloma working group (IMWG) response criteria.


Secondary Outcome Measures :
  1. Very Good Partial Response (VGPR) Rate [ Time Frame: Up to 24 months ]
    VGPR rate is defined as the percentage of patients who achieve a VGPR or better according to IMWG response criteria.

  2. Complete Response (CR) Rate [ Time Frame: Up to 24 months ]
    CR rate is defined as the percentage of patients who achieve a complete response (CR) or better according to IMWG response criteria.

  3. Stringent Complete Response (sCR) Rate [ Time Frame: Up to 24 months ]
    sCR rate is defined as the percentage of patients who achieve a stringent complete response (sCR) according to IMWG response criteria.

  4. Minimal Residual Disease (MRD) Negative Rate [ Time Frame: Up to 24 months ]
    Minimal residual disease (MRD) negative rate is defined as the percentage of patients with negative MRD status according to IMWG response criteria.

  5. Clinical Benefit Rate (CBR) [ Time Frame: Up to 24 months ]
    CBR is defined as the percentage of patients with clinical benefit. CBR = ORR (sCR + CR + VGPR + PR) + minimal response (MR).

  6. Duration of Response [ Time Frame: Up to 24 months ]
    Duration of response is defined as time from the date of initial documentation of a response (PR or better) to the date of first documented evidence of progressive disease (according to IMWG criteria).

  7. Time to Response [ Time Frame: Up to 24 months ]
    Time to response is defined as the time between the date of Day 1 of Cycle 1 and the first clinical response evaluation that the patient has met all criteria for PR or better response.

  8. Time to Next Treatment [TTNT] [ Time Frame: Up to 24 months ]
    Time to next treatment is defined as the time from diagnosis to the start of the next-line treatment.

  9. Progression-free Survival (PFS) [ Time Frame: Up to 24 months ]
    PFS is defined as the time from the date of Day 1 of Cycle 1 to the date of first documented disease progression (according to IMWG response criteria) or death due to any cause, whichever occurs first.

  10. Time to Progression on the Next Line of Subsequent Antimyeloma Therapy or Death (PFS2) [ Time Frame: Up to 24 months ]
    PFS2 is defined as the time from the date of Day 1 of Cycle 1 to progression on the next line of subsequent antimyeloma therapy or death, whichever occurs first.

  11. Overall Survival (OS) [ Time Frame: Up to 24 months ]
    Overall survival is the duration from the date of Day 1 of Cycle 1 to the date of the patient's death or study completion, whichever occurs first.

  12. Change from Baseline in Health-related Quality of Life (HRQoL) using European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Scale Score [ Time Frame: Baseline up to 24 months ]
    The EORTC QLQ-C30 version 3 includes 30 items in 5 functional scales, 1 global health status scale, 3 symptom scales, and 6 single symptom items. The responses are reported using a verbal rating scale. The item and scale scores are transformed to a 0 to 100 scale. A higher score represents greater health-related quality-of-life (HRQoL), better functioning, and more (worse) symptoms.

  13. Change from Baseline in Health-related Quality of Life (HRQoL) using European Organization for Research and Treatment of Cancer (EORTC) QLQ-MY20 Scale Score [ Time Frame: Baseline up to 24 months ]
    The EORTC QLQ-MY20 was designed to use alongside the EORTC QLQ-C30 to address issues of more relevance to myeloma patients. Four single items from the EORTC QLQ-MY20 will be performed to assess emotional health status (feel restless or agitated, thinking about your illness, worried about dying, worried about health in the future) on scale of 1 (not at all) to 4 (very much).

  14. Change from Baseline in Health-related Quality of Life (HRQoL) using EQ-5D-5L Questionnaire Score [ Time Frame: Baseline up to 24 months ]
    EuroQol Five Dimension (EQ-5D-5L) is a 5-item questionnaire that assesses 5 domains including mobility, self-care, usual activities, pain/discomfort and anxiety/depression plus a visual analog scale rating "health today" with anchors ranging from 0 (worst imaginable health state) to 100 (best imaginable health state).

  15. Number of Patients with Adverse Events (AEs) [ Time Frame: Up to 24 months ]
    An AE is any untoward medical occurrence in a patient participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.

  16. Severity of Adverse Events as Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) [ Time Frame: Up to 24 months ]
    Severity of AEs has 5 grades based on CTCAE criteria: Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Life-threatening consequences; Grade 5: Death related to adverse event.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with relapsed/refractory multiple myeloma (RRMM) receiving antimyeloma treatment as standard of care (SOC) under routine clinical practice will be observed. The main source of data collection will be medical records of each patient.
Criteria

Inclusion Criteria:

  • Have a documented diagnosis of multiple myeloma according to International myeloma working group (IMWG) diagnostic criteria
  • Received at least 3 prior lines of therapy or are double refractory to a proteasome inhibitor (PI) and an immunomodulatory agent (IMID) (induction with or without hematopoietic stem cell transplant and with or without maintenance therapy is considered a single regimen). Patients will have undergone at least 1 complete cycle of treatment for each regimen (unless progressive disease was the best response)
  • Must have documented evidence of progressive disease based on study physician's determination of response by the IMWG response criteria on or after the last regimen. Patients with documented evidence of progressive disease within the previous 6 months and who are refractory or nonresponsive to their most recent line of treatment afterwards are also eligible
  • Have an Eastern Cooperative Oncology Group (ECOG) Performance Status grade of 0 or 1
  • Must not be pregnant or must not plan to become pregnant within the study period

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04035226


Contacts
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Contact: Study Contact 844-434-4210 JNJ.CT@sylogent.com

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Sponsors and Collaborators
Janssen-Cilag Ltd.
Legend Biotech
Investigators
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Study Director: Janssen-Cilag Ltd. Clinical Trial Janssen-Cilag Ltd.

Additional Information:
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Responsible Party: Janssen-Cilag Ltd.
ClinicalTrials.gov Identifier: NCT04035226     History of Changes
Other Study ID Numbers: CR108651
68284528MMY4001 ( Other Identifier: Janssen-Cilag Ltd. )
First Posted: July 29, 2019    Key Record Dates
Last Update Posted: October 17, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Antibodies
Immunoglobulins
Antibodies, Monoclonal
Proteasome Inhibitors
Immunologic Factors
Physiological Effects of Drugs
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action