Daratumumab in Combination With Bortezomib and Dexamethasone in Subjects With Relapsed or Relapsed and Refractory Multiple Myeloma and Severe Renal Impairment

Sponsor
Universitätsklinikum Hamburg-Eppendorf
Study ID
NCT02977494
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Daratumumab — DRUG
    Daratumumab (JNJ-54767414) is a novel human IgG1monoclonal Antibody (mAb) that binds with high affinity to a unique epitope on CD38
  • Bortezomib — DRUG
  • Dexamethasone — DRUG

Study Details

Myeloma patients with renal impairment need a rapid and effective reduction of tumor burden to enable renal recovery, which is correlated with prognosis of the patients. However, effective combination regimens are often hampered by necessary dose reductions or increased toxicity in renally impaired patients. The well known positive effects on renal impairment by Bortezomib combined with Daratumumab, which, as all monoclonal Antibody, is not renally excreted or metabolized and as so far known should not add significant toxicity but efficacy, makes the proposed combination of Daratumumab, Bortezomib and Dexamethasone highly attractive for renally impaired MM patients. In the current clinical trials with Daratumumab patients with renal function impairment (GFR ≤ 20 ml/min) were so far excluded. Consequently questions about efficacy, safety and pharmacokinetics of Daratumumab in combination with Bortezomib and Dexamethasone in patients with relapsed and refractory MM and severe renal impairment are still unanswered. This trial will answer these questions for a patient group, who has still an unmet need for novel and effective treatment options

Key Dates

Start date
Jun 30, 2016
Status verified
May 2022
Primary completion
Jun 30, 2021
Completion
Jun 30, 2021

Study Design

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

Arms

  • Experimental: Daratumumab Bortezomib

Primary Outcome Measure

Evaluate the efficacy (overall response rate, ORR according to IMWG recommendations) of the combination of daratumumab, bortezomib and dexamethasone in subjects with relapsed and refractory MM and impaired renal function [ Time Frame: two years ]

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