Phase 2
N=17
Pomalidomide, Ixazomib Citrate, and Dexamethasone in Treating Patients With Previously Treated Multiple Myeloma or Plasma Cell Leukemia
Plasma Cell Leukemia · Plasma Cell Myeloma · Plasmacytoma
Bottom Line
View on ClinicalTrials.gov: NCT02547662 ↗Enrolled (actual)
17
Serious AEs
29.4%
Results posted
May 2022
Primary outcome: Primary: Confirmed Response Rate — 0.06 proportion of patients
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Dexamethasone (Drug); Ixazomib Citrate (Drug); Laboratory Biomarker Analysis (Other); Pomalidomide (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mayo Clinic
- Primary completion
- Oct 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Confirmed Response Rate |
0.06 | — |
| SECONDARY Biochemical Response Rate |
0.25 | — |
| SECONDARY Extramedullary Response Rate |
0.40 | — |
| SECONDARY Incidence of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 |
17 | — |
| SECONDARY Progression-free Survival |
4.5 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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 = = grade 3 peripheral neuropathy, or grade 2 with pain on clinical examination during the screening period
- Major surgery = 470 milliseconds (msec) on a 12-lead ECG obtained during the screening period
- Note: If a machine reading is above this value, the ECG should be reviewed by a qualified reader and confirmed on a subsequent ECG
- Known human immunodeficiency virus (HIV) positive
- Known hepatitis B surface antigen-positive status, or known or suspected active hepatitis C infection
- Any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to this protocol
- Known allergy to any of the study medications, their analogues or excipients in the various formulations
- Known gastrointestinal (GI) disease or GI procedure that could interfere with the oral absorption or tolerance of ixazomib including difficulty swallowing
- Diarrhea > grade 1, based on the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) grading, in the absence of antidiarrheals
Data sourced from ClinicalTrials.gov (NCT02547662). 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.