NIPH Clinical Trials Search

Ixazomib maintenance following Daratumumab/Lenalidomide/ Dexamethasone combination therapy for newly diagnosed multiple myeloma patients study

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Multiple myeloma
Date of first enrollment	22/04/2026
Target sample size	55
Countries of recruitment
Study type	Interventional
Intervention(s)	Cohort A will retrospectively collect medical chart information from patients who received DLd therapy as initial treatment for multiple myeloma, achieved a response of PR or better, and either completed Ixa maintenance therapy or are currently undergoing Ixa maintenance therapy, with written informed consent obtained from the patients for study participation. The efficacy and safety during the maximum dosing period for each case will be evaluated. Additionally, for patients undergoing Ixa maintenance therapy, the effects of Ixa maintenance therapy will be monitored in a prospective interventional study. Cohort B will prospectively enroll and conduct study treatment on patients who received DLd therapy as initial treatment for multiple myeloma, achieved PR or better, and agreed in writing to switch to Ixa maintenance therapy and participate in the study. Efficacy and safety will be evaluated from the point of switching to Ixa maintenance therapy. Biomarker analysis will be performed in some cases.

Outcome(s)

Primary Outcome	Achievement rate of each subcategorical response based on the IMWG Uniform Response Criteria and MRD-negative achievement rate in patients during Ixa maintenance therapy.
Secondary Outcome	- Adverse Events Adverse events during Ixa maintenance therapy, mainly focusing on infections - The following indicators and their changes during Ixa maintenance therapy: Complete Response (CR) rate Overall Response Rate (ORR) Time to Response (TTR) Progression-Free Survival (PFS) Normal immunoglobulin levels Immune marker biomarkers (cohort B only)

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	Not applicable
Gender	Both
Include criteria	Cohort A This study targets patients with multiple myeloma who received DLd therapy as initial treatment, achieved a response of PR (partial response) or better, and have either completed Ixa maintenance therapy or are currently undergoing Ixa maintenance therapy, and who have provided written informed consent to participate in the study. Patients who meet all of the following eligibility criteria are considered eligible. To avoid selection bias of study subjects, all patients meeting the following criteria at the participating study sites will be enrolled in this study. 1. Patients who have been diagnosed with multiple myeloma. 2. Patients who received DLd therapy as initial treatment and achieved a response of PR or better. There are no regulations regarding the starting dose of each drug in DLd therapy, and the use of other drugs up to one course before starting DLd therapy is permitted. However, patients who became resistant to proteasome inhibitors and immunomodulatory drugs during the one course before starting DLd therapy are excluded. 3. Patients who, after receiving DLd therapy and achieving a response of PR or better, have either completed Ixa monotherapy maintenance or are currently undergoing Ixa monotherapy. The dose, treatment-free interval, or presence of adverse events related to Ixazomib prior to enrollment will not affect eligibility. 4. Patients aged 18 years or older at the time of consent. 5. Patients who have provided written informed consent to participate in the study. Cohort B This refers to cases involving patients who, as initial treatment for multiple myeloma, received DLd therapy and achieved a response of partial response (PR) or better, and from whom written consent was obtained regarding the switch to Ixa maintenance therapy and participation in this study. Patients who meet all of the following eligibility criteria and do not meet any of the exclusion criteria are considered eligible. 1. Patients diagnosed with multiple myeloma. 2. Patients who received DLd therapy as initial treatment and achieved a response of PR or better. There are no regulations regarding the starting dose of each drug in DLd therapy, and the use of other drugs up to one course before starting DLd therapy is permitted. However, patients who became resistant to proteasome inhibitors and immunomodulatory drugs during the one course before starting DLd therapy are excluded. 3. Patients with an ECOG PS of 0, 1, or 2. Temporary decreases in PS at the time of diagnosis due to pain associated with the primary disease are excluded. 4. Patients 18 years of age or older at the time of consent. 5. Patients from whom written informed consent to participate in the study has been obtained.
Exclude criteria	1. Patients with severe infectious complications for whom continued Ixa maintenance therapy is difficult. 2. Patients with renal impairment requiring maintenance dialysis. 3. Patients with severe major organ dysfunction. 4. Patients with a history of hypersensitivity that makes continued treatment difficult. 5. Female patients who are pregnant, breastfeeding, or may be pregnant. 6. Patients whom the study investigator deems inappropriate for participation in this trial.