18 and older, any sex, with Amyloidosis or Plasma Cell Myeloma. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Maximum Tolerated (MTD) Dose of Cyclophosphamide With Ixazomib and Dexamethasone (Phase I)Primary· At 28 days
Will be defined as the dose level below the lowest dose that induces dose-limiting toxicity in at least 1/3 of patients, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0.
Percentage of Patients With Complete Response or Very Good Partial Response (Phase II, Cohort A)Primary· Up to 48 weeks
The percentage of successes will be estimated by the number of successes divided by the total number of evaluable patients. Exact binomial 95% confidence intervals for the true success proportion will be calculated.
Rate of Complete Response, Very Good Partial Response, or Partial Response (Phase II, Cohort B)Primary· Up to 48 weeks
The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. Exact binomial 95% confidence intervals for the true success proportion will be calculated.
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 4.0Secondary· Up to 5 years
The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine patterns. Additionally, the relationship of the adverse event(s) to the study treatment will be taken into consideration. Adverse events will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. A grade 3 event is one that is severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL.
Group
Value
95% CI
Phase I/II, Cohort A
36
Phase II, Cohort B
16
Progression-free Survival (PFS)Secondary· Time from registration to the earliest date of documentation of disease progression or death due to any cause, assessed up to 5 years
The distribution of PFS will be estimated using the method of Kaplan Meier.
Group
Value
95% CI
Phase I/II, Cohort A
NA
31.3 – NA
Phase II, Cohort B
NA
39.6 – NA
Survival TimeSecondary· Time from registration to death due to any cause, assessed up to 5 years
The distribution of survival time will be estimated using the method of Kaplan-Meier.
Group
Value
95% CI
Phase I/II, Cohort A
NA
NA – NA
Phase II, Cohort B
NA
NA – NA
Maximum Tolerated (MTD) Dose of Cyclophosphamide (Phase I)Primary· At 28 days
Will be defined as the dose level below the lowest dose that induces dose-limiting toxicity in at least 1/3 of patients, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0.
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.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
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Currently open trials in the same condition.
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Trials by the same sponsor.
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Mayo Clinic
Last refreshed: 24 July 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01864018.