Daratumumab in Combination With Bortezomib and Dexamethasone in Newly Diagnosed Transplant Ineligible Multiple Myeloma

Sponsor
Singapore General Hospital
Study ID
NCT03695744
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Daratumumab — DRUG
    Daratumumab
  • Bortezomib — DRUG
    Bortezomib
  • Dexamethasone — DRUG
    Dexamethasone

Study Details

Newly diagnosed Multiple Myeloma patients who are ineligible for a transplant have inferior outcomes to that of the transplant population. This is an area of high unmet need and calls for newer therapies with novel mechanisms of action to improve survival in this non-transplant eligible (NTE) group. Daratumumab is a monoclonal antibody that targets CD38 expressed at high levels on myeloma plasma cells. In phase 1/2 studies, it has demonstrated impressive single agent activity in relapse and refractory myeloma with a very acceptable toxicity profile. This set the stage for combinations with daratumumab to increase efficacy and improve outcomes of patients in both the relapse refractory and newly diagnosed settings. Two large Phase 2 trails using lenalidomide and dexamethasone or bortezomib and dexamethasone along with Daratumumab demonstarted the impressive efficacy of antibody based 3 drug combinations in the relapsed refractory myeloma setting. More recently a large clinical trial using a Bortezomib based 4 drug combination with Daratumumab was reported from Europe in the first-line treatment of transplant ineligible Myeloma patients showing very good survival outcomes. Hence the investigators hypothesize that the combination of Daratumumab with bortezomib and dexamethasone in the NTE population may therefore improve efficacy and clinical outcomes.

Key Dates

Start date
Oct 2, 2019
Status verified
Jul 2023
Primary completion
Sep 30, 2021
Completion
Apr 30, 2024

Study Design

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

Arms

  • Experimental: Daratumumab Bortezomib Dexamethasone
    IV daratumumab 16mg/kg body weight weekly for weeks 1-9 followed by daratumumab 16mg/kg body weight once every 3 weeks from weeks 10 to 24 and then daratumumab 16mg/kg once every 4 weeks from weeks 25 onwards until disease progression; S.C bortezomib and PO Dexamethasone 40mg (starting dose of dexamethasone is 20mg once weekly for patients \>75 years old) once weekly for 9 months from start of study. After 9 months, patient only continues on daratumumab until progression.

Primary Outcome Measure

Overall Response [ Time Frame: From the date of treatment commencement till the date of best response as per IMWG definitions, upto 3 years ]

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