A Study of Belantamab Mafodotin in Multiple Myeloma Participants With Normal and Impaired Hepatic⦠(NCT04398680) | Clinical Trial Compass
WithdrawnPhase 1
A Study of Belantamab Mafodotin in Multiple Myeloma Participants With Normal and Impaired Hepatic Function
Stopped: Sponsor Decision
United States0Started 2021-04-20
Plain-language summary
The purpose of this study is to assess the pharmacokinetics (PK), safety, and tolerability of belantamab mafodotin monotherapy in Relapsed/Refractory Multiple Myeloma (RRMM) participants with impaired hepatic function and in matched RRMM participants with normal hepatic function.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Participants are capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the Informed Consent Form.
* Male and/or female must be 18 years of age or older, at the time of signing the informed consent.
* Eastern Cooperative Oncology Group performance status 0-2.
* Participants with histologically or cytologically confirmed diagnosis of multiple myeloma, as defined in International Myeloma Working Group criteria: Has failed at least 1 prior line of anti-myeloma
* Participants has measurable disease with at least one of the following: Serum M-protein greater than or equal to (\>=)0.5 grams per deciliter (g/dL) \>=5 grams per liter \[g/L\]); Urine M-protein \>=200 milligram per 24 hours (mg/24 hr); and Serum free light chain assay: Involved free light chain level \>=10 milligrams per deciliter (mg/dL) (\>=100 milligrams per liter \[mg/L\]); abnormal serum free light chain ratio (\<0.26 or \>1.65); participants with plasmacytoma and otherwise non-measurable disease
* Participants with a history of autologous SCT are eligible for study participation provided the following eligibility criteria are met: 1. Transplant was \>100 days prior to study enrollment, 2. No active infection(s), and 3. Participant meets the remainder of the eligibility criteria outlined in this protocol.
* Participants with adequate organ system functions as defined below: Absolute neutrophil count \>=1.0 times 10\^9/liter (L); Hā¦
What they're measuring
1
Part 1 and Part 2: Maximum observed plasma concentration (Cmax) of Belantamab Mafodotin
Timeframe: Up to 48 months
2
Part 1 and Part 2: Time to Cmax (Tmax) of Belantamab Mafodotin
Timeframe: Up to 48 months
3
Part 1 and Part 2: Concentration at the end of infusion (C-EOI)
Timeframe: Up to 48 months
4
Part 1 and Part 2: Predose plasma concentration (Ctrough) of Belantamab Mafodotin
Timeframe: Up to 48 months
5
Part 1 and Part 2: Area under the plasma concentration-time curve (from zero to the end of dosing interval)
Timeframe: Up to 48 months
6
Part 1 and Part 2: Last time point where the concentration is above the limit of quantification (Tlast) of Belantamab Mafodotin
Timeframe: Up to 48 months
7
Part 1 and Part 2: Cmax of total monoclonal antibody (mAb)