Phase 2
N=8
Ixazomib Citrate, Pomalidomide, Dexamethasone, Stem Cell Transplant in Treating Relapsed or Refractory Multiple Myeloma
Recurrent Plasma Cell Myeloma · Refractory Plasma Cell Myeloma
Bottom Line
View on ClinicalTrials.gov: NCT03202628 ↗Enrolled (actual)
8
Serious AEs
50.0%
Results posted
May 2022
Primary outcome: Primary: Progression-free Survival at 18 Months (PFS18) Defined as the Proportion of Patients Alive and Free From Disease Progression at 18 Months From Study Entry — 0.3750 proportion of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Autologous Hematopoietic Stem Cell Transplantation (Procedure); Dexamethasone (Drug); Ixazomib Citrate (Drug); Laboratory Biomarker Analysis (Other); Pomalidomide (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mayo Clinic
- Primary completion
- Apr 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-free Survival at 18 Months (PFS18) Defined as the Proportion of Patients Alive and Free From Disease Progression at 18 Months From Study Entry |
0.3750 | — |
| SECONDARY Percentage of Participants With Greater Than or Equal to (>=) Very Good Partial Response (VGPR) Rate |
25 | — |
| SECONDARY Number of Patients Experiencing Adverse Events Graded According to the Medical Dictionary for Regulatory Activities (MedDRA) Version (v) 12.1 |
7 | — |
| SECONDARY Overall Response Rate |
50 | — |
| SECONDARY Percent of Patients Alive at 30 Months |
75 | — |
Summary
This phase II trial studies how well ixazomib citrate, pomalidomide, dexamethasone, and stem cell transplantation works in treating patients with multiple myeloma that has come back or does not respond to treatment. Giving chemotherapy, such as pomalidomide and dexamethasone, before a stem cell transplant helps kill any cancer cells that are in the body and helps make room in the patient?s bone marrow for new blood-forming cells (stem cells) to grow. After treatment, stem cells are collected from the patient's blood and stored. More chemotherapy is then given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy. Giving ixazomib citrate in addition to pomalidomide, dexamethasone, and stem cell transplantation may work better in treating patients with relapsed or refractory multiple myeloma.
Eligibility Criteria
Inclusion Criteria
- Previously treated ASCT naive MM patients, currently with relapsed or refractory disease who are being considered for single ASCT for relapsed disease; patients must be eligible to undergo a stem cell transplant as per institutional criteria for selection at the time of registration
- Calculated creatinine clearance (using Cockcroft-Gault equation) >= 30 mL/min
- Absolute neutrophil count (ANC) >= 1000/mm^3
- Platelet count >= 75 x 10^9/L unless the participant has >= 50% bone marrow infiltration in which case a platelet count of >= 50 x 10^9/L is allowed
- Hemoglobin >= 9.0 g/dL
- Total bilirubin = 1.5 x ULN, the direct bilirubin must be = = 1.0 g/dL by protein electrophoresis
- >= 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
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2
- Willing to provide informed written consent
- Negative pregnancy test done = = grade 2 peripheral neuropathy, or grade 1 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
- 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 study treatment including difficulty swallowing
- Diarrhea > grade 1, based on the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v) 4.0 grading, in the absence of antidiarrheals
- Failure to have fully recovered (i.e., =< grade 1 toxicity) from the reversible effects of prior chemotherapy
- Radiotherapy =< 14 days prior to registration; NOTE: If the involved field is small, 7 days will be considered a sufficient interval between treatment and administration of the ixazomib
- Central nervous system involvement with disease under study (myeloma), or concurrent AL amyloidosis or plasma cell leukemia
- Patients that have previously been treated with ixazomib, or participated in a study with ixazomib whether treated with ixazomib or not
- Prior stem cell transplantation for myeloma
Data sourced from ClinicalTrials.gov (NCT03202628). 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.