Ixazomib and Dexamethasone With or Without Venetoclax in Treating Patients With Non-t(11;14) Relapsed or Refractory Multiple Myeloma

Sponsor
National Cancer Institute (NCI)
Study ID
NCT03856112
Phase
PHASE1/PHASE2
Status
Withdrawn

Conditions

  • Recurrent Plasma Cell Myeloma
  • Refractory Plasma Cell Myeloma
  • t(11;14) Negative

Eligibility Criteria

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

Interventions

  • Dexamethasone — DRUG
    Given PO
  • Ixazomib — DRUG
    Given PO
  • Ixazomib Citrate — DRUG
    Given PO
  • Venetoclax — DRUG
    Given PO

Study Details

This phase I/II trial studies the best dose and side effects of venetoclax and how well it works in combination with ixazomib and dexamethasone in treating patients with t(11;14) negative multiple myeloma that has come back or does not respond to treatment. Ixazomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as venetoclax and dexamethasone work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known how well venetoclax works with ixazomib and dexamethasone in treating patients with multiple myeloma.

Key Dates

Start date
Jun 21, 2019
Status verified
Mar 2019
Primary completion
Dec 31, 2021
Completion
Dec 31, 2021

Study Design

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

Arms

  • Experimental: Arm I (ixazomib, venetoclax, dexamethasone)
    Patients receive ixazomib citrate PO on days 1, 8, and 15, venetoclax PO QD on days 1-28 and dexamethasone PO on days 1, 8, 15, and 22. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
  • Active Comparator: Arm II (ixazomib, dexamethasone)
    Patients receive ixazomib citrate PO on days 1, 8, and 15, 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 III (ixazomib, venetoclax, dexamethasone)
    PI-refractory patients receive ixazomib citrate, venetoclax and dexamethasone as Arm I.

Primary Outcome Measure

Maximum tolerated dose/recommended phase II dose (MTD/RP2D) of venetoclax (Phase I) [ Time Frame: Up to 28 days ]

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