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)

Janssen (J&J Innovative Medicine)

Status: Completed

Conditions: Multiple Myeloma

Treatments: Other: No intervention

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT04035226

CR108651

68284528MMY4001 (Other Identifier)

Details and patient eligibility

About

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).

Enrollment: 254 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

254 participants in 1 patient group

Relapsed/refractory Multiple Myeloma

Description:

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.

Treatment:

Other: No intervention