Daratumumab, Bortezomib, Dexamethasone, Pegylated Liposomal Doxorubicin Hydrochloride, and Lenalidomide in Treating Participants With Plasma Cell Leukemia

Part of paid clinical trials in Duarte, California.

Sponsor
City of Hope Medical Center
Study ID
NCT03591744
Phase
PHASE1
Status
Withdrawn

Conditions

  • Plasma Cell Leukemia

Eligibility Criteria

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

Interventions

  • Bortezomib — DRUG
    Given SC
  • Daratumumab — BIOLOGICAL
    Given IV
  • Dexamethasone — DRUG
    Given IV and PO
  • Lenalidomide — DRUG
    Given PO
  • Pegylated Liposomal Doxorubicin Hydrochloride — DRUG
    Given IV

Study Details

This phase I trial studies side effects of daratumumab, bortezomib, dexamethasone, pegylated liposomal doxorubicin hydrochloride, and lenalidomide in treating participants with plasma cell leukemia. Monoclonal antibodies, such as daratumumab, may interfere with the ability of cancer cells to grow and spread. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as, dexamethasone, pegylated liposomal doxorubicin hydrochloride, and lenalidomide, 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. Giving daratumumab, bortezomib, dexamethasone, pegylated liposomal doxorubicin hydrochloride, and lenalidomide in treating participants with plasma cell leukemia.

Key Dates

Start date
Oct 25, 2018
Status verified
Dec 2018
Primary completion
Oct 25, 2019
Completion
Oct 25, 2019

Study Design

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

Arms

  • Experimental: Treatment (daratumumab, bortezomib, chemotherapy)
    Participants receive daratumumab IV on days 1, 8, 15, and 22, dexamethasone IV/PO on days 1, 2, 8, 9, 15, 16, 22, and 23, pegylated liposomal doxorubicin hydrochloride IV on day 8, lenalidomide PO daily on days 1-14, and bortezomib SC on days 1, 4, 8, and 11 of courses 1 and 2. Participants then receive daratumumab IV on days 1, and 15, dexamethasone IV/PO on days 1, 2, 8, 9, 15, 16, 22, and 23, pegylated liposomal doxorubicin hydrochloride IV on day 8, lenalidomide PO daily on days 1-14, and bortezomib SC on days 1, 4, 8, and 11 of courses 3 and 4. Courses repeat every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Participants may receive up to 8 courses at the discretion of treating physician.

Primary Outcome Measure

Incidence of adverse events assessed by National Cancer Institute-Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 [ Time Frame: Up to 30 days ]

Locations (5)

FacilityCityStateZIPSite coordinators
City of Hope Medical CenterDuarteCalifornia91010-
Mayo ClinicRochesterMinnesota55905-
Siteman Cancer Center at Washington UniversitySt LouisMissouri63110-
Carolinas Medical Center/Levine Cancer InstituteCharlotteNorth Carolina28203-
Sarah Cannon Cancer CenterNashvilleTennessee37203-

Find similar trials in Duarte, CA

By research site
City of Hope Medical Center· Duarte, CAMayo Clinic· Rochester, MNSiteman Cancer Center at Washington University· St Louis, MOCarolinas Medical Center/Levine Cancer Institute· Charlotte, NCSarah Cannon Cancer Center· Nashville, TN

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