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Monoclonal Antibodies
Pembrolizumab for Multiple Myeloma
Phase 1 & 2
Waitlist Available
Led By Noa Biran, MD
Research Sponsored by Hackensack Meridian Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Male/female participants who are at least 18 years of age on the day of signing informed consent with histologically confirmed diagnosis of multiple myeloma.
a proteasome inhibitor
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study Summary
This trial is testing a new combination of drugs to treat patients with multiple myeloma who haven't responded to other treatments.
Eligible Conditions
- Refractory Multiple Myeloma
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
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)
Secondary outcome measures
Overall Survival (OS)
Progression-Free Survival (PFS)
Time to next treatment
+1 moreSide effects data
From 2024 Phase 2 trial • 57 Patients • NCT0300418321%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Kidney Injury and/or Infection
7%
Pneumonia
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Activated partial thromboplastin time prolonged
5%
Intractable pain, back pain, hip pain
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Skin rash
2%
Thrombocytopenia
2%
Respiratory failure
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm
Trial Design
1Treatment groups
Experimental Treatment
Group I: Single-arm, multi-institutionExperimental Treatment3 Interventions
Study Arm:
Pembrolizumab 200 mg IV q3 weeks Belantamab 2.5 mg/kg IV q3 weeks. Dex 40 mg IV q3 weeks (20 mg if patient >75) Treatment will be administered on a 21-day cycle and will be continued until unacceptable toxicity or disease progression for up to 2 years (35 cycles)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~1950
Belantamab mafodotin
2019
Completed Phase 1
~10
Dexamethasone
2007
Completed Phase 4
~2590
Find a Location
Who is running the clinical trial?
Hackensack Meridian HealthLead Sponsor
131 Previous Clinical Trials
28,244 Total Patients Enrolled
20 Trials studying Multiple Myeloma
1,420 Patients Enrolled for Multiple Myeloma
Merck Sharp & Dohme LLCIndustry Sponsor
3,862 Previous Clinical Trials
5,049,700 Total Patients Enrolled
37 Trials studying Multiple Myeloma
11,420 Patients Enrolled for Multiple Myeloma
Noa Biran, MDPrincipal InvestigatorDivision of Hematology and Oncology
3 Previous Clinical Trials
163 Total Patients Enrolled
3 Trials studying Multiple Myeloma
163 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 any availability for patients to join this clinical trial?
"According to the information posted on clinicaltrials.gov, this medical trial is not seeking any new patients at present. The study was first created in December of 2022 and modified lastly in August of 2022. Although recruitment has closed for this particular investigation, there are 807 other trials actively recruiting participants currently."
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