Phase 2
N=87
Ixazomib With Cyclophosphamide and Dexamethasone in Patients With Previously Untreated Symptomatic Multiple Myeloma or Light Chain Amyloidosis
Amyloidosis · Plasma Cell Myeloma
Bottom Line
View on ClinicalTrials.gov: NCT01864018 ↗Enrolled (actual)
87
Serious AEs
37.4%
Results posted
Sep 2022
Primary outcome: Primary: Maximum Tolerated (MTD) Dose of Cyclophosphamide With Ixazomib and Dexamethasone (Phase I) — 4; 40 mg weekly
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Cyclophosphamide (Drug); Dexamethasone (Drug); Ixazomib Citrate (Drug); Laboratory Biomarker Analysis (Other); Pharmacological Study (Other); Quality-of-Life Assessment (Other); Questionnaire Administration (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mayo Clinic
- Primary completion
- Apr 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Tolerated (MTD) Dose of Cyclophosphamide With Ixazomib and Dexamethasone (Phase I) |
4; 40 | — |
| PRIMARY Percentage of Patients With Complete Response or Very Good Partial Response (Phase II, Cohort A) |
35 | — |
| PRIMARY Rate of Complete Response, Very Good Partial Response, or Partial Response (Phase II, Cohort B) |
63 | — |
| PRIMARY Maximum Tolerated (MTD) Dose of Cyclophosphamide (Phase I) |
400 | — |
| SECONDARY Number of Patients Experiencing a Grade 3 or Greater Adverse Event at Least Possibly Related to Treatment as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 |
36; 16 | — |
| SECONDARY Progression-free Survival (PFS) |
NA; NA | — |
| SECONDARY Survival Time |
NA; NA | — |
Summary
This phase I/II trial studies the side effects and the best dose of cyclophosphamide when given together with ixazomib citrate and dexamethasone in treating patients with previously untreated symptomatic multiple myeloma or light chain amyloidosis. Drugs used in chemotherapy, such as cyclophosphamide 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. Ixazomib citrate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving cyclophosphamide together with ixazomib citrate and dexamethasone may be a better treatment for multiple myeloma or light chain amyloidosis.
Eligibility Criteria
Inclusion Criteria
- PHASE I ONLY:
- COHORT A: multiple myeloma
- COHORT B: biopsy proven light chain amyloidosis with organ involvement requiring therapy
- Calculated creatinine clearance (using Cockcroft-Gault equation) >= 30 mL/min
- Absolute neutrophil count (ANC) >= 1000/mm^3
- Platelet count >= 75000/mm^3
- Hemoglobin >= 8.0 g/dL
- Total bilirubin = 14 days should have elapsed from the last day of radiation; NOTE: 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
- Measurable disease of multiple myeloma as defined by at least ONE of the following:
- Serum monoclonal protein >= 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
- COHORT B ONLY: serum immunoglobulin free light chain >= 5 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
- Provide informed written consent
- Negative pregnancy test done = = grade 3 on clinical examination or grade 2 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
- Participation in clinical trials with other investigational agents not included in this trial, =< 30 days prior to registration
Data sourced from ClinicalTrials.gov (NCT01864018). 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.