A Perspective Study of the MRD-tailored Therapy in Patients With Newly Diagnosed Multiple Myeloma With Persistent Minimal Residual Disease After Initial Treatment

Launched by FENGYAN JIN · Oct 29, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new approach to treating patients with newly diagnosed multiple myeloma, particularly those who still have minimal residual disease (MRD) after their initial treatment. MRD means that while the main signs of cancer might have gone away, there are still very small amounts of cancer cells that can remain in the body. The goal of the trial is to see if switching these patients to a stronger treatment can help them achieve better outcomes, like a longer period without the disease getting worse and improved overall survival compared to those who have successfully cleared their MRD.

To participate in this trial, you need to be at least 18 years old and have been diagnosed with symptomatic multiple myeloma. You should have responded to at least one prior treatment. Women who can become pregnant must agree to use reliable birth control during the study. Participants will be closely monitored throughout the trial to assess how well the new treatment works in eliminating MRD and improving survival rates. It's important to know that individuals with certain other conditions or types of myeloma won't be eligible for this study. If you or someone you know is interested, it’s a good idea to discuss it with a healthcare provider to see if it’s a suitable option.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Subject must be at least 18 years of age.
• • 2. Subject must have documented newly diagnosed symptomatic multiple myeloma as defined by 2014 International Myeloma Working Group criteria.
• • 3. Subject must have achieved a response (partial response \[PR\] or better based on investigator's determination of response by the IMWG criteria) to at one prior regimen.
• • 4. Women of childbearing potential must commit to either abstain continuously from heterosexual sexual intercourse or to use 2 methods of reliable birth control simultaneously. Contraception must begin 4 weeks prior to dosing and continue until at least 3 months after receiving the last dose of the study drug. A woman of childbearing potential must have a negative serum or urine pregnancy tests at screening within 14 days prior to randomization.
• • 5. Each subject (or their legally acceptable representative) must sign an informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study and are willing to participate in the study.
• Exclusion Criteria:
• • 1. Subject has a diagnosis of primary amyloidosis, monoclonal gammopathy of undetermined significance, or smoldering multiple myeloma. Monoclonal gammopathy of undetermined significance is defined by presence of serum M-protein \<3 g/dL; absence of lytic bone lesions, anemia, hypercalcemia, and renal insufficiency related to the M-protein; and (if determined) proportion of plasma cells in the bone marrow of 10% or less. Smoldering multiple myeloma is defined as asymptomatic multiple myeloma with absence of related organ or tissue impairment or end-organ damage.
• • 2. Relapsed and refractory myeloma：Relapsed and refractory myeloma is defined as disease that is nonresponsive while on salvage therapy, or progresses within 60 days of last therapy in patients who have achieved minimal response (MR) or better at some point previously before then progressing in their disease course.
• • 3. Primary refractory myeloma：Primary refractory myeloma is defined as disease that is nonresponsive in patients who have never achieved a minimal response or better with any therapy.
• • 4. Subject is known or suspected of not being able to comply with the study protocol。 Subject has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the subject or that could prevent, limit, or confound the protocol-specified assessments.