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

Launched by JANSSEN PHARMACEUTICA N.V., BELGIUM · Dec 15, 2021

Keywords

ClinConnect Summary

This clinical trial is studying how well current treatments for multiple myeloma work in everyday medical practice. Specifically, it focuses on patients who have already received treatment for their multiple myeloma, but their disease has either come back or did not respond to previous therapies. The trial will last for 24 months and aims to see how safe and effective these standard treatments are for these patients in a real-world setting.

To be eligible for the study, participants need to have a confirmed diagnosis of multiple myeloma and must have had at least three previous treatment attempts. They should also be well enough to participate, with a performance status that indicates they can carry out daily activities. Importantly, women who are pregnant or planning to become pregnant during the study cannot take part. Those who join the trial will be monitored closely to gather information on how their disease responds to the treatments they receive. This study is currently looking for participants, so it's a great opportunity for those who meet the criteria and are seeking further treatment options.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • For Period 1, 2 and 3
• • Have a documented diagnosis of multiple myeloma according to International myeloma working group (IMWG) diagnostic criteria
• • 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
• • Participants must sign an informed consent form (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
• • For Period 1 and 2: Received at least 3 prior lines of therapy (induction with or without hematopoietic stem cell transplant and with or without maintenance therapy is considered a single regimen). Undergone at least 1 complete cycle of treatment for each line of therapy, unless progressive disease (PD) was the best response to the line of therapy
• • Must have documented evidence of progressive disease based on participating physician's determination of response by the IMWG response criteria on or after the last regimen. Participants with documented evidence of progressive disease within the previous 6 months and who are refractory or non-responsive to their most recent line of treatment afterwards are also eligible
• • Measurable disease at screening as defined by any of the following: Serum monoclonal paraprotein (M-protein) level 1.0 g/dL or urine M-protein level 200 mg/24 hours; or Light chain multiple myeloma without measurable disease in the serum or the urine: Serum immunoglobulin free light chain 10 mg/dL and abnormal serum immunoglobulin kappa lambda free light chain ratio
• • Period 1: Received as part of previous therapy a PI, an IMiD, and an anti-CD38 antibody (prior exposure can be from different monotherapy or combination regimens)
• • Period 2: Received as part of previous therapy a PI, an IMiD, an anti-CD38 antibody, and BCMA-targeted therapy (prior exposure can be from different monotherapy or combination regimens)
• • For period 3: Measurable disease at screening as defined by any of the following: Serum monoclonal paraprotein (M-protein) level .5 g/dL or urine M-protein level 200 mg/24 hours; or Light chain multiple myeloma without measurable disease in the serum or the urine: Serum immunoglobulin free light chain 10 mg/dL and abnormal serum immunoglobulin kappa lambda free light chain ratio