Ixazomib Citrate in Treating Patients With Relapsed Multiple Myeloma That Is Not Refractory to Bortezomib

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
Mayo Clinic
Study ID
NCT01415882
Phase
PHASE2
Status
Completed

Conditions

  • Recurrent Plasma Cell Myeloma
  • Refractory Plasma Cell Myeloma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cyclophosphamide — DRUG
    Given PO
  • Daratumumab — BIOLOGICAL
    Given IV
  • Dexamethasone — DRUG
    Given PO or IV
  • Ixazomib Citrate — DRUG
    Given PO
  • Laboratory Biomarker Analysis — OTHER
    Correlative studies

Study Details

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.

Key Dates

Start date
Jan 31, 2012
Status verified
Aug 2025
Primary completion
Apr 21, 2023
Completion
Apr 30, 2025

Study Design

Enrollment
165 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Proportion of Confirmed Responses With Ixazomib Citrate Alone (Arm A [Closed]), Ixazomib Citrate With Dexamethasone (Arms B + C), or With Dexamethasone and Cyclophosphamide (Arm D), or With Dexamethasone, Cyclophosphamide, Daratumumab (Arm E) [ Time Frame: 2.5 years ]

Locations (3)

FacilityCityStateZIPSite coordinators
Mayo Clinic in ArizonaScottsdaleArizona85259-
Mayo Clinic in FloridaJacksonvilleFlorida32224-9980-
Mayo Clinic in RochesterRochesterMinnesota55905-

Find similar trials in Scottsdale, AZ

By research site
Mayo Clinic in Arizona· Scottsdale, AZMayo Clinic in Florida· Jacksonville, FLMayo Clinic in Rochester· Rochester, MN

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