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Monoclonal Antibodies

Belantamab mafodotin lyophilized powder for Multiple Myeloma

Phase 2
Waitlist Available
Research Sponsored by GlaxoSmithKline
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
All prior treatment-related toxicities must be <=Grade 1 at the time of enrollment except for alopecia and Grade 2 peripheral neuropathy
The participant has measurable disease with at least one of the following: Serum M-protein >=0.5 grams per deciliter (g/dL) (>=5 grams per Liter [g/L]); Urine M-protein >=200 milligram per 24 hours (mg/24h); Serum Free light chain (FLC) assay: Involved FLC level >=10 mg/dL (>=100 mg/Liter) and an abnormal serum FLC ratio (<0.26 or >1.65)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (day 1) and week 07, week 13, week 19, week 25, week 31, week 37, week 43, week 61, week 79, week 97, week 115, week 133, week 151, week 169, and week 186
Awards & highlights

Study Summary

This trial will study the efficacy and safety of belantamab mafodotin, a drug for treating relapsed or refractory multiple myeloma, a cancer of the plasma cells.

Who is the study for?
Adults with Multiple Myeloma who have failed at least three prior treatments, including an anti-CD38 antibody and are refractory to certain drugs. They must have adequate organ function, not be pregnant or breastfeeding, agree to contraception use, and cannot have had recent major surgery or other disqualifying conditions.Check my eligibility
What is being tested?
The trial is testing two doses of belantamab mafodotin (GSK2857916) in frozen liquid or lyophilized powder form for safety and effectiveness in treating Multiple Myeloma. Participants will receive the drug intravenously until disease progression or unacceptable toxicity occurs.See study design
What are the potential side effects?
Potential side effects include eye problems like blurry vision, dryness or corneal issues; blood disorders; fatigue; infusion reactions; liver enzyme changes; kidney function alterations; and potential heart complications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My side effects from previous treatments are mild, except for hair loss and some nerve pain.
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My blood or urine tests show signs of disease.
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I can take care of myself and am up and about more than half of my waking hours.
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I have MM, failed 3 treatments including an anti-CD38, IMiD, and proteasome inhibitor.
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I am a male and will follow the required contraceptive guidelines.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (day 1) and week 07, week 13, week 19, week 25, week 31, week 37, week 43, week 61, week 79, week 97, week 115, week 133, week 151, week 169, and week 186
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (day 1) and week 07, week 13, week 19, week 25, week 31, week 37, week 43, week 61, week 79, week 97, week 115, week 133, week 151, week 169, and week 186 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall Response Rate (ORR) by Independent Review Committee (IRC) (Full Analysis Population)
Overall Response Rate by Independent Review Committee (Efficacy Population)
Secondary outcome measures
AUC(0-infinity) of Cysteine-maleimidocaproyl Monomethyl Auristatin F (Cys-mcMMAF) Following IV Dose of GSK2857916 in Participants With RRMM
AUC(0-infinity) of GSK2857916 Total Antibody Following IV Dose in Participants With RRMM
AUC(0-tau) of Cys-mcMMAF Following IV Dose of GSK2857916 in Participants With RRMM
+57 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: Participants receiving lyophilized belantamab mafodotinExperimental Treatment1 Intervention
Participants in lyophilized arm will receive lyophilized belantamab mafodotin once lyophilized configuration becomes available and enrollment has been completed for frozen liquid arms.
Group II: Participants receiving frozen 3.4 mg/kg belantamab mafodotinExperimental Treatment1 Intervention
Participants will receive 3.4 mg/kg frozen liquid belantamab mafodotin. Participants will be administered with frozen liquid belantamab mafodotin via infusion pump every 3 weeks.
Group III: Participants receiving frozen 2.5 mg/kg belantamab mafodotinExperimental Treatment1 Intervention
Participants will receive 2.5 mg/kg frozen liquid belantamab mafodotin. Participants will be administered with frozen liquid belantamab mafodotin via infusion pump every 3 weeks.

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Who is running the clinical trial?

GlaxoSmithKlineLead Sponsor
4,751 Previous Clinical Trials
8,067,251 Total Patients Enrolled
47 Trials studying Multiple Myeloma
6,212 Patients Enrolled for Multiple Myeloma
GSK Clinical TrialsStudy DirectorGlaxoSmithKline
3,595 Previous Clinical Trials
6,143,709 Total Patients Enrolled
25 Trials studying Multiple Myeloma
3,183 Patients Enrolled for Multiple Myeloma

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there an extant body of research related to Belantamab mafodotin lyophilized powder?

"Belantamab mafodotin lyophilized powder was initially investigated in 2015 at Weill Cornell Medicine / New york Presbyterian Hospital. To this day, there have been two concluded clinical trials and 33 are actively enrolling patients with a large proportion of these studies based out of Atlanta, Georgia."

Answered by AI

Is enrollment open for this medical experiment presently?

"This research program is no longer accepting new volunteers. It was originally posted on June 18th, 2018 and ended editing in July 27th 2022. If you are looking for alternative studies, 807 clinical trials recruiting patients with multiple myeloma and 33 separate investigations into Belantamab mafodotin lyophilized powder are currently in active search of enrollees."

Answered by AI

Is this a pioneering research endeavor?

"Currently, there are 33 active clinical trials for Belantamab mafodotin lyophilized powder scattered across 221 urban centres and 34 countries. Karyopharm Therapeutics Inc initiated the first drug approval study in 2015 which involved 518 patients and finished its Phase 1 & 2 stages. Since then, two more have been conducted."

Answered by AI

In what scenarios is Belantamab mafodotin lyophilized powder often employed?

"Belantamab mafodotin lyophilized powder can be employed to modulate the immune system and address various medical issues including a history of proteasome inhibitor treatment, refractory multiple myeloma, or prior anti-cd38 monoclonal antibody therapy."

Answered by AI

To what extent can Belantamab mafodotin lyophilized powder be detrimental to a patient's health?

"Belantamab mafodotin lyophilized powder has been assessed with a score of 2 on the safety scale due to existing data supporting its relative security, though there is not yet any evidence confirming efficacy."

Answered by AI

What goals is the clinical trial striving to achieve?

"Per the trial's patron, GlaxoSmithKline, the primary outcome to be monitored over a timespan of up to 48 weeks is Overall Response Rate as assessed by an Independent Review Committee (Efficacy Population). Additionally, this research will evaluate secondary outcomes such as the Number of Participants With Grade Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure using NCI CTCAE version 4.03 grading criteria for each metric. The AUC(0-tlast) of GSK2857916 Total Antibody Following IV Dose in Participants With RRMM and Tmax of Cys-"

Answered by AI

What is the breadth of locations in which this research endeavor is being conducted?

"This research trial is enrolling at a total of 21 sites, including Atlanta, New Haven and Chicago. To minimize travel needs, participants should select the site nearest to them for participation."

Answered by AI

How many participants have enrolled in the experiment thus far?

"This scientific trial has ceased patient recruitment. The study was first listed on June 18th 2018 and the page was last updated July 27th 2022. There are 807 trials recruiting individuals with multiple myeloma, as well as 33 studies actively looking for volunteers to test Belantamab mafodotin lyophilized powder."

Answered by AI
Recent research and studies
~32 spots leftby Apr 2025