Pomalidomide, Ixazomib Citrate, and Dexamethasone in Treating Patients With Previously Treated Multiple Myeloma or Plasma Cell Leukemia
Phase 2 Trial of Pomalidomide, Ixazomib and Dexamethasone in Patients With Multiple Myeloma With Extramedullary Disease or Plasma Cell Leukemia
2 other identifiers
interventional
17
1 country
2
Brief Summary
This phase II trial studies how well pomalidomide, ixazomib citrate, and dexamethasone work in treating patients with previously treated multiple myeloma or plasma cell leukemia. Biological therapies, such as pomalidomide and dexamethasone, use substances made from living organisms that may stimulate or suppress the immune system in different ways and stop cancer cells from growing. Ixazomib citrate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving pomalidomide, ixazomib citrate, and dexamethasone together may be more effective in treating multiple myeloma.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Dec 2015
Longer than P75 for phase_2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 10, 2015
CompletedFirst Posted
Study publicly available on registry
September 11, 2015
CompletedStudy Start
First participant enrolled
December 24, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
October 30, 2020
CompletedResults Posted
Study results publicly available
May 23, 2022
CompletedOctober 30, 2023
October 1, 2023
4.9 years
September 10, 2015
November 1, 2021
October 26, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Confirmed Response Rate
A confirmed response is defined as a patient who has achieved a stringent complete response (sCR), complete response (CR), very good partial response (PR), or PR on two consecutive evaluations. The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. Ninety-five percent confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
4 years
Secondary Outcomes (4)
Biochemical Response Rate
4 years
Extramedullary Response Rate
4 years
Incidence of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
4 years 1 month
Progression-free Survival
4 years 8 months
Other Outcomes (1)
Proportion of Patients Who Achieve Minimal Residual Disease (MRD) Negative Status
Up to 5 years
Study Arms (1)
Treatment (ixazomib citrate, pomalidomide, dexamethasone)
EXPERIMENTALPatients receive ixazomib citrate PO on days 1, 8, and 15, pomalidomide PO on days 1-21, and dexamethasone PO on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Interventions
Given PO
Given PO
Correlative studies
Given PO
Eligibility Criteria
You may qualify if:
- Previously treated myeloma, currently with extramedullary disease (defined as plasmacytoma outside bone marrow that is not contiguous with a bone lesion) with at least one lesion that has a single diameter of \>= 2 cm or plasma cell leukemia (defined as circulating plasma cells exceeding 5% of peripheral blood leukocytes or 0.5 X 10\^9/L or 200 cells/150000 events by flow cytometry)
- Calculated creatinine clearance (using Cockcroft-Gault equation) \>= 30 mL/min
- Absolute neutrophil count (ANC) \>= 1000/mm\^3
- Platelet count \>= 50,000/mm\^3
- Hemoglobin \>= 8.0 g/dL
- Patients with measurable disease defined as at least one of the following:
- For patients with extramedullary disease (EMD) measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) or the CT portion of the positron emission tomography (PET)/CT: must have at least one lesion that has a single diameter of \>= 2 cm; skin lesions can be used if the area is \>= 2 cm in at least one diameter and measured with a ruler
- Plasma cell count \>= 0.5 X 10\^9/L or 5 percent of the peripheral blood white cells
- Plasma cell count if determined by flow cytometry, \>= 200/150,000 events
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2
- Provide informed written consent
- Negative pregnancy test done =\< 7 days prior to registration, for women of childbearing potential only
- All study participants must be registered into the mandatory pomalidomide (POMALYST) Risk Evaluation and Mitigation Strategy (REMS) program, and be willing and able to comply with the requirements of the POMALYST REMS program
- Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study)
- Willing to provide bone marrow and blood samples for correlative research purposes
You may not qualify if:
- Other malignancy requiring active therapy
- EXCEPTIONS: Non-melanoma skin cancer, ductal breast carcinoma in situ (DCIS) or carcinoma-in-situ of the cervix
- NOTE: If there is a history or prior malignancy, they must not be receiving other specific treatment for their cancer
- Females of childbearing potential (FCBP)\* must have a negative serum pregnancy test with a sensitivity of at least 50 mIU/mL within 10-14 days prior to and again within 24 hours prior to prescribing pomalidomide for cycle 1 (prescriptions must be filled within 7 days as required by RevAssist \[lenalidomide REMS program\]), and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method; AT THE SAME TIME, at least 28 days before she starts taking pomalidomide FCBP must also agree to ongoing pregnancy testing; men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy; patient must follow pregnancy testing requirements as outlined in the POMALYST REMS program
- A female of childbearing potential is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)
- Nursing women
- Men or women of childbearing potential who are unwilling to employ adequate contraception
- Other co-morbidity which would interfere with patient's ability to participate in trial, e.g. uncontrolled infection, uncompensated heart or lung disease
- Other concurrent chemotherapy, radiotherapy, or any ancillary therapy considered investigational
- NOTE: Bisphosphonates are considered to be supportive care rather than therapy, and are thus allowed while on protocol treatment
- Patient has \>= grade 3 peripheral neuropathy, or grade 2 with pain on clinical examination during the screening period
- Major surgery =\< 14 days before study registration
- Systemic treatment with strong CYP3A4 inducers (e.g. rifampin, rifapentine, rifabutin, carbamazepine, phenytoin, phenobarbital, gingko biloba, St. John's wort) within 7 days before registration
- Evidence of current uncontrolled cardiovascular conditions, including cardiac arrhythmias, congestive heart failure, angina, or myocardial infarction within the past 6 months; Note: prior to study entry, any electrocardiogram (ECG) abnormality at screening must be documented by the investigator as not medically relevant
- Corrected QT Interval (QTc) \> 470 milliseconds (msec) on a 12-lead ECG obtained during the screening period
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
Study Sites (2)
Mayo Clinic
Rochester, Minnesota, 55905, United States
Sarah Cannon Cancer Center
Nashville, Tennessee, 37203, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Shaji Kumar MD
- Organization
- Mayo Clinic
Study Officials
- PRINCIPAL INVESTIGATOR
Shaji Kumar
Mayo Clinic
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 10, 2015
First Posted
September 11, 2015
Study Start
December 24, 2015
Primary Completion
October 30, 2020
Study Completion
October 30, 2020
Last Updated
October 30, 2023
Results First Posted
May 23, 2022
Record last verified: 2023-10