Bortezomib, Isatuximab, Cyclophosphamide and Dexamethasone Induction in Transplant-Eligible Multiple Myeloma Patients With Renal Insufficiency

Part of paid clinical trials in Milwaukee, Wisconsin.

Sponsor
Medical College of Wisconsin
Study ID
NCT04240054
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

  • Bortezomib — DRUG
    Bortezomib (1.5 mg/m\^2) subcutaneous on days 1, 8 and 15
  • Isatuximab — DRUG
    Isatuximab (10 mg/kg) IV on days 1, 8, 15 and 22
  • Cyclophosphamide — DRUG
    Cyclophosphamide (250 mg/m\^2) IV on days 1, 8 and 15
  • Dexamethasone — DRUG
    Dexamethasone 20 mg PO or IV (10 mg if \>75 years) on days 1, 2, 8, 9, 15, 16, 22 and 23

Study Details

This is a single-arm, open-label phase II study with a safety lead-in phase.

Key Dates

Start date
Nov 2, 2021
Status verified
Jan 2026
Primary completion
Dec 1, 2029
Completion
Dec 1, 2030

Study Design

Enrollment
41 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Safety Lead-in Cohort A
    Six transplant-eligible multiple myeloma patients with renal impairment will be enrolled. Bortezomib (1.5 mg/m\^2) subcutaneous on days 1,8 and 15 Isatuximab (10 mg/kg) IV on days 1, 8, 15 and 22 Cyclophosphamide (250 mg/m\^2) IV on days 1, 8 and 15 Dexamethasone 20 mg PO or IV (10 mg if \>75 years) on days 1, 2, 8, 9,15,16, 22 and 23
  • Experimental: Expansion Cohort A
    35 transplant-eligible multiple myeloma patients with renal impairment will be enrolled. Bortezomib (1.5 mg/m\^2)subcutaneous on days 1, 8 and 15 Isatuximab (10 mg/kg) IV on days 1, 8, 15 and 22 Cyclophosphamide (250 mg/m\^2) IV on days 1, 8 and 15 Dexamethasone 20 mg PO or IV (10 mg if \>75 years) on days 1, 2, 8, 9,15,16, 22 and 23

Primary Outcome Measure

The number of subjects who achieve very good partial response. [ Time Frame: 100 days following autologous stem cell transplant ]

Central Contacts

  • Medical College of Wisconsin Cancer Center Clinical Trials Office
    866-680-0505
    [email protected]

Locations (1)

FacilityCityStateZIPSite coordinators
Froedtert Hospital & the Medical College of WisconsinMilwaukeeWisconsin53226
Medical College of Wisconsin Cancer Center Clinical Trials Office
[email protected]
866-680-0505
Binod Dhakal, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Milwaukee, WI

By condition
Multiple myeloma
By specialty
OncologyBlood cancer
By research site
Froedtert Hospital & the Medical College of Wisconsin· Milwaukee, WI

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