← Back to Search

Monoclonal Antibodies

Pembrolizumab for Multiple Myeloma (DREAMM 4 Trial)

Phase 1 & 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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 31 months
Awards & highlights

DREAMM 4 Trial Summary

This trial is testing a new drug to treat multiple myeloma that has come back or does not respond to other treatments. The new drug will be given with another drug that is already used to treat this disease. The trial will see if the new drug is safe and works well with the other drug.

Eligible Conditions
  • Multiple Myeloma

DREAMM 4 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 31 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 31 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Part 1 - Changes From Baseline in Urine Potential of Hydrogen (pH)
Part 1 - Changes From Baseline in Urine Specific Gravity
Part 1 - Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
+9 more
Secondary outcome measures
Part 1 - AUC (0-tau) for Pembrolizumab After First Dose
Part 1 - AUC (0-tau) for Total mAb After First Dose
Part 1 - AUC From Time 0 to 168 h After Dosing [AUC (0-168h)] for Cys-mcMMAF After First Dose
+71 more

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183
21%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Pneumonia
7%
Kidney Injury and/or Infection
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm

DREAMM 4 Trial Design

2Treatment groups
Experimental Treatment
Group I: Part 2: Expansion cohortExperimental Treatment2 Interventions
Subjects will receive belantamab mafodotin at RP2D along with 200 mg pembrolizumab via IV infusion on Day 1 of each 21-day cycle. There will be maximum of 35 cycles of combination treatment.
Group II: Part 1: Dose escalationExperimental Treatment2 Interventions
Subjects will receive belantamab mafodotin at escalating doses of 2.5 milligrams per kilograms (mg/kg) and 3.4 mg/kg along with 200 mg pembrolizumab via intravenous (IV) infusion on Day 1 of each 21-day cycle to establish RP2D. There will be maximum of 35 cycles of combination treatment.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
belantamab mafodotin
2019
Completed Phase 2
~50
Pembrolizumab
2017
Completed Phase 2
~2010

Find a Location

Who is running the clinical trial?

GlaxoSmithKlineLead Sponsor
4,750 Previous Clinical Trials
8,067,411 Total Patients Enrolled
47 Trials studying Multiple Myeloma
6,392 Patients Enrolled for Multiple Myeloma
Merck Sharp & Dohme LLCIndustry Sponsor
3,886 Previous Clinical Trials
5,054,530 Total Patients Enrolled
37 Trials studying Multiple Myeloma
11,379 Patients Enrolled for Multiple Myeloma
GSK Clinical TrialsStudy DirectorGlaxoSmithKline
3,595 Previous Clinical Trials
6,143,889 Total Patients Enrolled
25 Trials studying Multiple Myeloma
3,363 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.

What are the standard applications for Pembrolizumab?

"Unresectable melanoma is a type of cancer that can be effectively managed with pembrolizumab. Additionally, this medication can also help patients with microsatellite instability high, those at high risk of recurrence, and other disease states."

Answered by AI

How many people are recruited for this experiment?

"This study is not looking for new participants at the moment. The trial was first advertised on March 14th, 2019 and updated as recently as May 11th, 2022. Currently, there are 827 other trials related to multiple myeloma and 1032 trials concerning Pembrolizumab that are searching for volunteers."

Answered by AI

What are the goals of this research?

"According to the sponsor, GlaxoSmithKline, the primary outcome for this trial will be Part 1: The number of patients with abnormal hematology readings. This objective will be evaluated over a two-year period. Additionally, investigators will also be looking at secondary outcomes including Part 2:maximum concentration in blood plasma following administration of GSK2857916 intravenously in combination with pembrolizumab after the first dose., Part 2: time until best response is observed (as defined as the time between date of first dose and first best documented response among subjects who achieved a confirmed response of PR or better), and Part"

Answered by AI

What are some similar investigations that have utilized Pembrolizumab?

"First studied in 2010 at City of Hope, pembrolizumab has completed 251 clinical trials with approximately 1032 active studies. A large number of these investigations are being conducted out of Charlotte, North carolina."

Answered by AI

Is this clinical trial being administered in multiple states?

"Presently, this experiment is being conducted in Charlotte, Indianapolis and Toronto; as well as 6 other cities. To cut down on travel time and costs, select the site that is geographically closest to you."

Answered by AI

Are new enrollees still being accepted for this experiment?

"Currently, this clinical trial is not recruiting patients. The study was first posted on 3/14/2019 and updated for the last time on 5/11/2022. There are 827 other trials actively looking for candidates with multiple myeloma and 1032 trials involving Pembrolizumab that are currently admitting patients."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Study Evaluating Safety, Tolerability and Clinical Activity of GSK2857916 in Combination With Pembrolizumab in Subjects With Relapsed/Refractory Multiple Myeloma (RRMM)
2019. "Study Evaluating Safety, Tolerability and Clinical Activity of GSK2857916 in Combination With Pembrolizumab in Subjects With Relapsed/Refractory Multiple Myeloma (RRMM)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03848845.
~7 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top