Phase 2
Completed N=80
Ixazomib Citrate, Lenalidomide, Dexamethasone, and Daratumumab in Treating Patients With Newly Diagnosed Multiple Myeloma
Source: ClinicalTrials.gov NCT03012880 ↗Enrolled (actual)
80
Serious AEs
22.8%
Results posted
Jun 2025
Primary outcomePrimary: Proportion of Patients Who Achieve a Confirmed Complete Response (CR) — 0.32; 0.30 proportion of participants
Summary
This phase II trial studies how well ixazomib citrate, lenalidomide, dexamethasone, and daratumumab work in treating patients with newly diagnosed multiple myeloma. Ixazomib citrate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as lenalidomide and dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as daratumumab, may block cancer growth in different ways by targeting certain cells. Giving ixazomib citrate, lenalidomide, dexamethasone, and daratumumab may work better in treating patients with newly diagnosed multiple myeloma.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Patients Who Achieve a Confirmed Complete Response (CR) |
0.32; 0.30 | — |
| SECONDARY Proportion of Patients That Experienced a Grade 3 or Higher Adverse Event. |
0.58; 0.53 | — |
| SECONDARY Overall Response Rate (ORR) |
0.97; 0.95 | — |
| SECONDARY Overall Survival (OS) |
NA; NA | — |
| SECONDARY Progression Free Survival |
NA; NA | — |
| SECONDARY Rate of >= Very Good Partial Response (VGPR) |
0.74; 0.68 | — |
Eligibility Criteria
Inclusion Criteria
- Calculated creatinine clearance (using Cockcroft-Gault equation) >= 30 mL/min
- Absolute neutrophil count (ANC) >= 1500/mm^3
- Untransfused platelet count >= 75000/mm^3
- Hemoglobin >= 8.0 g/dL
- Total bilirubin = = 1.0 g/dL
- >= 200 mg of monoclonal protein in the urine on 24 hour electrophoresis
- Serum immunoglobulin free light chain >= 10 mg/dL AND abnormal serum immunoglobulin kappa to lambda free light chain ratio
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2
- Previously untreated for myeloma or have received no more than one cycle of any treatment regimen; NOTE: Prior radiation therapy for the treatment of solitary plasmacytoma is permitted; prior therapy with clarithromycin, dehydroepiandrosterone (DHEA), anakinra, pamidronate or zoledronic acid is permitted; any additional agents not listed must be approved by the principal investigator
- Provide informed written consent
- Negative pregnancy test done = = grade 2 on clinical examination or grade 1 with pain during the screening period
- Major surgery = grade 1, based on the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) grading, in the absence of antidiarrheals
Data sourced from ClinicalTrials.gov (NCT03012880). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.