Phase 2 Trial of Ixazomib Combinations in Patients With Relapsed Multiple Myeloma

Who is this study for? Patients with Plasma Cell Myeloma
What treatments are being studied? Dexamethasone+Ixazomib Citrate+Laboratory Biomarker Analysis
Status: Active_not_recruiting
Location: See all (3) locations...
Intervention Type: Drug, Biological, Other
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

This phase II trial studies how well ixazomib citrate works in treating patients with multiple myeloma that has returned after a period of improvement (relapsed) but is not resistant to bortezomib (refractory). Ixazomib citrate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Calculated creatinine clearance (using Cockcroft-Gault equation) \>= 30 mL/min (obtained =\< 14 days prior to registration)

• Absolute neutrophil count \>= 1000/mL (obtained =\< 14 days prior to registration)

• Untransfused platelet count \>= 75000/mL (obtained =\< 14 days prior to registration)

• Hemoglobin \>= 8.0 g/dL (obtained =\< 14 days prior to registration)

• Total bilirubin =\< 1.5 x the upper limit of the normal range (ULN) (obtained =\< 14 days prior to registration)

• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =\< 3 x ULN (obtained =\< 14 days prior to registration)

• Patients with relapsed multiple myeloma who have already received one or more standard treatment regimens

• 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

⁃ 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, 2

• Provide informed written consent

• Negative pregnancy test done =\< 7 days prior to registration, for women of childbearing potential only

• Willing to return to consenting Mayo Clinic institution for follow-up during the Active Monitoring Phase of the study; Note: during the Active Monitoring Phase of a study (i.e., active treatment and observation), participants must be willing to return to the consenting institution for follow-up

• Recovered (i.e., \< grade 1 toxicity) from the reversible effects of prior antineoplastic therapy

• Arms A - D only: Patients should be proteasome inhibitor naive (including bortezomib and carfilzomib) OR have received less than 6 cycles of therapy with a bortezomib or carfilzomib containing regimen and were not refractory to the bortezomib or carfilzomib based regimen (less than a PR or progression on or within 60 days of discontinuation)

• Arm E only: Negative hepatitis B test (defined by a negative test for hepatitis B surface antigen \[HBsAg\], or antibodies to hepatitis B surface and/or core antigens \[antiHBs or antiHBc\]) (added as of addendum 9); Note: patients with serologic findings suggestive of hepatitis B virus (HBV) vaccination (antiHBs positivity as the only serologic marker) AND a known history of prior HBV vaccination do not need to be tested for HBV deoxyribonucleic acid (DNA) by polymerase chain reaction (PCR); those who are PCR positive will be excluded

Locations
United States
Arizona
Mayo Clinic in Arizona
Scottsdale
Florida
Mayo Clinic in Florida
Jacksonville
Minnesota
Mayo Clinic in Rochester
Rochester
Time Frame
Start Date: 2012-01-31
Completion Date: 2026-02-01
Participants
Target number of participants: 165
Treatments
Experimental: Arm A (ixazomib citrate and dexamethasone, closed to accrual)
Patients receive ixazomib citrate PO on days 1, 8, and 15. Patients with lack of minor response by the end of the second cycle or lack of partial response by the end of the fourth cycle also receive dexamethasone PO on days 1, 2, 8, 9, 15, and 16. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Experimental: Arm B (ixazomib citrate and dexamethasone)
Patients receive ixazomib citrate PO on days 1, 8, and 15 and dexamethasone PO on days 1, 8, and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Experimental: Arm C (higher-dose ixazomib citrate and dexamethasone)
Patients receive higher doses of ixazomib citrate PO on days 1, 8, and 15 and dexamethasone PO on days 1, 8, and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Experimental: Arm D (ixazomib citrate, dexamethasone, and cyclophosphamide)
Patients receive ixazomib citrate PO on days 1, 8, and 15 and cyclophosphamide PO (cycles 1-18 only) and dexamethasone PO on days 1, 8, 15, and 22. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Experimental: Arm E (ixazomib citrate, cyclophosphamide, daratumumab)
Patients receive ixazomib citrate PO on days 1, 8, and 15, cyclophosphamide PO (cycles 1-12 only) on days 1, 8, 15, 22, and daratumumab IV on days 1, 8, 15, 22 (cycles 1-2), days 1 and 15 (cycles 3-6), and day 1 in all subsequent cycles. Patients also receive dexamethasone IV or PO on days 1, 8, 15, and 22. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Related Therapeutic Areas
Sponsors
Leads: Mayo Clinic

This content was sourced from clinicaltrials.gov

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