A Study of Real-Life Current Standards of Care in Participants With Relapsed and/or Refractory Multiple Myeloma

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorJanssen Pharmaceutica N.V., Belgium

About this trial

The purpose of this study is to assess in real-life clinical practice, over a 24-month period, the effectiveness and safety and patient-reported outcomes (PROs) associated with standard of care (SOC) antimyeloma treatments in participants with previously treated relapsed and/or refractory multiple myeloma.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

For Period 1 and 2: Have a documented diagnosis of multiple myeloma according to International myeloma working group (IMWG) diagnostic criteria. For Period 3: Start of talquetamab for the treatment of a documented diagnosis of relapsed and/or refractory multiple myeloma (RRMM) according to IMWG diagnostic criteria and the approved indication. The decision to start talquetamab must be made independently of the decision to participate in the study, with the start of treatment occurring up to 28 days following the start of screening or having occurred up to 21 days before the informed consent form (ICF) date

For Period 1 and 2: Have an Eastern Cooperative Oncology Group (ECOG) Performance Status grade of 0 or 1. For Period 3: Have ECOG performance status of 0,1 or 2

For Period 1,2 and 3: Must not be pregnant or must not plan to become pregnant within the study period

For Period 1,2 and 3: Participants must sign an ICF indicating that he or she understands the purpose and observational nature of the study and is willing to participate. Consent is to be obtained prior to the initiation of any study-related data collection

Disqualifiers

None

Trial population

The study population consists of participants with previously treated multiple myeloma, having received standard of care (SOC) antimyeloma treatments during local clinical practices.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • No intervention

    Other intervention

    There is no interventional treatment component for participants with RRMM in this study.

Treatment groups

300 Participants
are divided into 1 treatment group
Group A: Participants with Relapsed/Refractory Multiple Myeloma1 intervention

Trial outcomes

Primary outcomes

1

Overall Response Rate (ORR)

Overall Response Rate is defined as the percentage of participants who achieve a partial response (PR) or better response according to the International Myeloma Working Group (IMWG) response criteria, as assessed by Response Review Committee (RRC).

Time frame
Up to 52 months

Secondary outcomes

1

Very Good Partial Response (VGPR) Rate

VGPR rate is defined as the percentage of participants who achieve a VGPR or better response according to IMWG response criteria.

Time frame
Up to 52 months
2

Complete Response (CR) Rate

CR rate is defined as the percentage of participants who achieve a CR or better response according to IMWG response criteria.

Time frame
Up to 52 months
3

Stringent Complete Response (sCR) Rate

sCR rate is defined as the percentage of participants who achieve a sCR according to IMWG response criteria.

Time frame
Up to 52 months
4

Minimal Residual Disease (MRD) Negative Rate

MRD negative rate is defined as the percentage of participants with negative MRD status according to IMWG response criteria.

Time frame
Up to 52 months

Other outcomes

Sponsors and contacts

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