Ixazomib With Cyclophosphamide and Dexamethasone in Patients With Previously Untreated Symptomati… (NCT01864018) | Clinical Trial Compass
CompletedPhase 1/2
Ixazomib With Cyclophosphamide and Dexamethasone in Patients With Previously Untreated Symptomatic Multiple Myeloma or Light Chain Amyloidosis
United States87 participantsStarted 2013-08-20
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 =\< 1.5 x upper limit of normal (ULN)
* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =\< 3 x ULN
* COHORT B ONLY: alkaline phosphatase =\< 750 U/L
* COHORT B ONLY: N-terminal pro b-type natriuretic peptide (NT-ProBNP) \< 7500 ng/dL
* Prior therapy for the treatment of solitary plasmacytoma is permitted, but \> 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 statu…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Maximum Tolerated (MTD) Dose of Cyclophosphamide With Ixazomib and Dexamethasone (Phase I)
Timeframe: At 28 days
2
Percentage of Patients With Complete Response or Very Good Partial Response (Phase II, Cohort A)
Timeframe: Up to 48 weeks
3
Rate of Complete Response, Very Good Partial Response, or Partial Response (Phase II, Cohort B)
Timeframe: Up to 48 weeks
4
Maximum Tolerated (MTD) Dose of Cyclophosphamide (Phase I)