Trial · NCT01864018
Ixazomib With Cyclophosphamide and Dexamethasone in Patients With Previously Untreated Symptomatic Multiple Myeloma or Light Chain Amyloidosis
NCT01864018, Phase 1, Phase 2, Completed, Mayo Clinic; results first posted 2022-09-21
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Ixazomib With Cyclophosphamide and Dexamethasone in Patients With Previously Untreated Symptomatic Multiple Myeloma or Light Chain Amyloidosis. Trials, record NCT01864018. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01864018
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Ixazomib With Cyclophosphamide and Dexamethasone in Patients With Previously Untreated Symptomatic Multiple Myeloma or Light Chain Amyloidosis
- NCT number
- NCT01864018
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 87 participants, actual
- Lead sponsor
- Mayo Clinic
- Conditions
- Amyloidosis, Plasma Cell Myeloma
- Interventions
- Cyclophosphamide, Dexamethasone, Ixazomib Citrate, Laboratory Biomarker Analysis, Pharmacological Study, Quality-of-Life Assessment, Questionnaire Administration
- First posted
- 2013-05-29
- Last updated
- 2025-07-24
- Results first posted
- 2022-09-21
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximum Tolerated (MTD) Dose of Cyclophosphamide With Ixazomib and Dexamethasone (Phase I) | 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. |
| Primary | Percentage of Patients With Complete Response or Very Good Partial Response (Phase II, Cohort A) | 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. |
| Primary | Rate of Complete Response, Very Good Partial Response, or Partial Response (Phase II, Cohort B) | 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. |
| Primary | Maximum Tolerated (MTD) Dose of Cyclophosphamide (Phase I) | 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. |
| 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 | 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. |
| Secondary | Progression-free Survival (PFS) | 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. |
| Secondary | Survival Time | 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. |
| Other | Pharmacokinetic (PK) Parameters | Post-dose, 1 and 4 hours on day 1, pre-dose on days 8, 15, and 22, and day 1 of course 2 | Will be estimated using noncompartmental analysis methods. The plasma PK parameters calculated for individual plasma ixazomib concentration-time data will include, but are not limited to: peak concentration, time to first maximum plasma concentration, and area under the curve. PK parameters will be summarized using descriptive statistics. |
| Other | Quality of Life, as Assessed by the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity Questionnaire | Up to 5 years | Patients will be evaluated by overall score at each time point and changes over time will be calculated. These measures will be correlated with outcome using Fisher's exact test and Kaplan-Meier methods where appropriate. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Maximum Tolerated (MTD) Dose of Cyclophosphamide With Ixazomib and Dexamethasone (Phase I) | At 28 days | The 10 patients accrued to the phase I portion of the study were analyzed to determine the maximum tolerated dose of ixazomib with cyclophosphamide and dexamethasone | mg weekly | NUMBER |
| PRIMARY | Percentage of Patients With Complete Response or Very Good Partial Response (Phase II, Cohort A) | Up to 48 weeks | Includes only eligible patients in phase II, cohort A | percentage of participants | NUMBER |
| PRIMARY | Rate of Complete Response, Very Good Partial Response, or Partial Response (Phase II, Cohort B) | Up to 48 weeks | Includes only patients with biopsy proven light chain amyloidosis with organ involvement\>\> requiring therapy at baseline | percentage of participants | NUMBER |
| 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 | Up to 5 years | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Progression-free Survival (PFS) | Time from registration to the earliest date of documentation of disease progression or death due to any cause, assessed up to 5 years | months | MEDIAN | |
| SECONDARY | Survival Time | Time from registration to death due to any cause, assessed up to 5 years | months | MEDIAN | |
| OTHER_PRE_SPECIFIED | Pharmacokinetic (PK) Parameters | Post-dose, 1 and 4 hours on day 1, pre-dose on days 8, 15, and 22, and day 1 of course 2 | |||
| OTHER_PRE_SPECIFIED | Quality of Life, as Assessed by the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity Questionnaire | Up to 5 years | |||
| PRIMARY | Maximum Tolerated (MTD) Dose of Cyclophosphamide (Phase I) | At 28 days | The 10 patients accrued to the phase I portion of the study were analyzed to determine the maximum tolerated dose of ixazomib with cyclophosphamide and dexamethasone | mg/m² weekly | NUMBER |
Source ClinicalTrials.gov
Results by group11
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Maximum Tolerated (MTD) Dose of Cyclophosphamide With Ixazomib and Dexamethasone (Phase I) | Treatment (Ixazomib Citrate, Cyclophosphamide, Dexamethasone) | MTD of ixazomib | 4 | mg weekly | |
| Maximum Tolerated (MTD) Dose of Cyclophosphamide With Ixazomib and Dexamethasone (Phase I) | Treatment (Ixazomib Citrate, Cyclophosphamide, Dexamethasone) | MTD of dexamethasone | 40 | mg weekly | |
| Percentage of Patients With Complete Response or Very Good Partial Response (Phase II, Cohort A) | Treatment (Ixazomib Citrate, Cyclophosphamide, Dexamethasone) | 35 | 95% Confidence Interval 22 to 50 | percentage of participants | |
| Rate of Complete Response, Very Good Partial Response, or Partial Response (Phase II, Cohort B) | Treatment (Ixazomib Citrate, Cyclophosphamide, Dexamethasone) | 63 | 95% Confidence Interval 45 to 79 | percentage of participants | |
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 | Phase I/II, Cohort A | 36 | Participants | ||
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 | Phase II, Cohort B | 16 | Participants | ||
| Progression-free Survival (PFS) | Phase I/II, Cohort A | NA | 95% Confidence Interval 31.3 to NA | months | |
| Progression-free Survival (PFS) | Phase II, Cohort B | NA | 95% Confidence Interval 39.6 to NA | months | |
| Survival Time | Phase I/II, Cohort A | NA | 95% Confidence Interval NA to NA | months | |
| Survival Time | Phase II, Cohort B | NA | 95% Confidence Interval NA to NA | months |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 results by groupParticipant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Phase I/II, Cohort A | 51 | |
| Overall Study | STARTED | Phase II, Cohort B | 36 | |
| Overall Study | Accrued During Phase I | Phase I/II, Cohort A | 10 | |
| Overall Study | Accrued During Phase I | Phase II, Cohort B | 0 | |
| Overall Study | Accrued During Phase II | Phase I/II, Cohort A | 41 | |
| Overall Study | Accrued During Phase II | Phase II, Cohort B | 36 | |
| Overall Study | COMPLETED | Phase I/II, Cohort A | 48 | |
| Overall Study | COMPLETED | Phase II, Cohort B | 35 | |
| Overall Study | NOT COMPLETED | Phase I/II, Cohort A | 3 | |
| Overall Study | NOT COMPLETED | Phase II, Cohort B | 1 |
Source ClinicalTrials.gov
Adverse events228
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anemia | Blood and lymphatic system disorders | Phase I/II, Cohort A | 14 | 48 | 29 |
| other | Anemia | Blood and lymphatic system disorders | Phase II, Cohort B | 2 | 35 | 3 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Phase I/II, Cohort A | 1 | 48 | 1 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Phase II, Cohort B | 0 | 35 | 0 |
| other | Chest pain - cardiac | Cardiac disorders | Phase I/II, Cohort A | 0 | 48 | 0 |
| other | Chest pain - cardiac | Cardiac disorders | Phase II, Cohort B | 1 | 35 | 2 |
| other | Heart failure | Cardiac disorders | Phase I/II, Cohort A | 1 | 48 | 5 |
| other | Heart failure | Cardiac disorders | Phase II, Cohort B | 0 | 35 | 0 |
| other | Hearing impaired | Ear and labyrinth disorders | Phase I/II, Cohort A | 1 | 48 | 4 |
| other | Hearing impaired | Ear and labyrinth disorders | Phase II, Cohort B | 0 | 35 | 0 |
1 to 10 of 228Source ClinicalTrials.gov
See all 228 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Phase I/II, Cohort A | 2 | 48 |
| Total, all-cause mortality | Phase II, Cohort B | 7 | 35 |
| Total, other adverse events | Phase I/II, Cohort A | 48 | 48 |
| Total, other adverse events | Phase II, Cohort B | 35 | 35 |
| Total, serious adverse events | Phase I/II, Cohort A | 16 | 48 |
| Total, serious adverse events | Phase II, Cohort B | 15 | 35 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 35737873 | DERIVED |
Source PubMed
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| P30CA015083 | Mayo Clinic Comprehensive Cancer Center Support Grant | WILLMAN, CHERYL LYNN | MAYO CLINIC ROCHESTER | NATIONAL CANCER INSTITUTE | 1985 to 2025 |
Source NIH RePORTER
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Phase I/II, Cohort A vs Phase II, Cohort B: deaths from any cause | Trial comparisons |
Phase I/II, Cohort A vs Phase II, Cohort B: 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 | Trial comparisons |
| Phase I/II, Cohort A vs Phase II, Cohort B: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01864018
GET https://conductscience.org/api/trials/v1/NCT01864018/events?page=2