A Study to Test the Combination of Selinexor (KPT-330), Ixazomib, and Dexamethasone in Patients With Myeloma

Part of paid clinical trials in Basking Ridge, New Jersey.

Sponsor
Memorial Sloan Kettering Cancer Center
Study ID
NCT02831686
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Selinexor — DRUG
  • Ixazomib — DRUG
  • Dexamethasone — DRUG

Study Details

The purpose of this study is to test the safety of a combination of study drugs called selinexor (KPT-330) and ixazomib (MLN9708) with a low dose of dexamethasone. This study tests different doses of the study drug, selinexor to see which dose is safer in people. Depending on which group (dose level) you are in, the dose of selinexor will vary, but the ixazomib and dexamethasone doses will be the same among the groups.

Key Dates

Start date
Jul 31, 2016
Status verified
Nov 2020
Primary completion
Nov 19, 2020
Completion
Nov 19, 2020

Study Design

Enrollment
18 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Selinexor (KPT-330), Ixazomib, and Dexamethasone
    Patients with relapsed and/or refractory MM will be treated with ixazomib, selinexor, and dexamethasone, all of which will be administered orally.Ixazomib will be given on Days 1, 8, and 15 on a 28 day cycle. Selinexor will be given twice weekly for three weeks, then there will be 1 week off (Days 1,3, 8,10, 15, 17) This study will follow a 3-by-3 dose escalation design. Dexamethasone will be given on all days of Selinexor but will also be given on the week off from Selinexor (Days 1, 3, 8, 10,15, 17, 22, 24).

Primary Outcome Measure

maximum tolerated dose (MTD) [ Time Frame: 1 year ]

Locations (7)

FacilityCityStateZIPSite coordinators
Memoral Sloan Kettering Basking RidgeBasking RidgeNew Jersey--
Memorial Sloan Kettering MonmouthMiddletownNew Jersey07748-
Memorial Sloan Kettering BergenMontvaleNew Jersey07645-
Memorial Sloan Kettering CommackCommackNew York11725-
Memorial Sloan Kettering WestchesterHarrisonNew York10604-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
Memorial Sloan Kettering NassauUniondaleNew York11553-

Find similar trials in Basking Ridge, NJ

By condition
Multiple myeloma
By specialty
OncologyBlood cancer
By research site
Memoral Sloan Kettering Basking Ridge· Basking Ridge, NJMemorial Sloan Kettering Monmouth· Middletown, NJMemorial Sloan Kettering Bergen· Montvale, NJMemorial Sloan Kettering Commack· Commack, NYMemorial Sloan Kettering Westchester· Harrison, NYMemorial Sloan Kettering Cancer Center· New York, NY

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