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Corticosteroid

Pembrolizumab for Multiple Myeloma

Phase 2
Waitlist Available
Led By Noa Biran, M.D.
Research Sponsored by Hackensack Meridian Health
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 3 years
Awards & highlights

Study Summary

This trial is testing a combination of drugs to treat patients with high risk Multiple Myeloma who have undergone chemotherapy and stem cell transplantation.

Eligible Conditions
  • Multiple Myeloma

Timeline

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Progression Free Survival (PFS)
Secondary outcome measures
Duration of Response (DOR)
Evaluation of Stringent Complete Response, Complete Response, and Very Good Partial Response Rate (sCR + CR + VGPR Rate).
Number of Participants Serious Adverse Events
+1 more
Other outcome measures
Assessment of Immune Phenotype in Bone Marrow Aspirates and Peripheral Blood Samples and Plasma Cytokines.
Assessment of Plasma Cytokines
Assessment of T Cell Repertoire in Bone Marrow Aspirates and Peripheral Blood Samples.
+2 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

Trial Design

1Treatment groups
Experimental Treatment
Group I: Pembrolizumab + lenalidomideExperimental Treatment3 Interventions
This is an open label study. Pembrolizumab 200 mg IV every 3 weeks and lenalidomide 25 mg po daily x 14 days and dexamethasone 40 mg po once weekly for a 21-day cycle x 2 cycles. This is followed by pembrolizumab 200 mg every 3 weeks and lenalidomide 25 mg po daily x 14 days for a 21-day cycle x 2 cycles for a total of 4 cycles.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2010
Lenalidomide
2005
Completed Phase 3
~1480
Dexamethasone
2007
Completed Phase 4
~2590

Find a Location

Who is running the clinical trial?

Hackensack Meridian HealthLead Sponsor
131 Previous Clinical Trials
28,232 Total Patients Enrolled
20 Trials studying Multiple Myeloma
1,408 Patients Enrolled for Multiple Myeloma
Noa Biran, M.D.Principal InvestigatorHackensack Meridian Health

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
ScienceJournal
Anticancer Immunotherapy by CTLA-4 Blockade Relies on the Gut Microbiota
Vétizou, Marie, Jonathan M. Pitt, Romain Daillère, Patricia Lepage, Nadine Waldschmitt, Caroline Flament, Sylvie Rusakiewicz, et al.. 2015. “Anticancer Immunotherapy by CTLA-4 Blockade Relies on the Gut Microbiota”. Science. American Association for the Advancement of Science (AAAS). doi:10.1126/science.aad1329.
Immunological ReviewsJournal
The PD-1 Pathway in Tolerance and Autoimmunity
Francisco, Loise M., Peter T. Sage, and Arlene H. Sharpe. 2010. “The PD-1 Pathway in Tolerance and Autoimmunity”. Immunological Reviews. Wiley. doi:10.1111/j.1600-065x.2010.00923.x.
Clinical Cancer ResearchJournal
PD-1 Is Expressed by Tumor-infiltrating Immune Cells and Is Associated with Poor Outcome for Patients with Renal Cell Carcinoma
Thompson, R. Houston, Haidong Dong, Christine M. Lohse, Bradley C. Leibovich, Michael L. Blute, John C. Cheville, and Eugene D. Kwon. 2007. “PD-1 Is Expressed by Tumor-infiltrating Immune Cells and Is Associated with Poor Outcome for Patients with Renal Cell Carcinoma”. Clinical Cancer Research. American Association for Cancer Research (AACR). doi:10.1158/1078-0432.ccr-06-2599.
European UrologyJournal
Prognostic Value of Renal Vein and Inferior Vena Cava Involvement in Renal Cell Carcinoma
Wagner, Bernd, Jean-Jacques Patard, Arnaud Méjean, Karim Bensalah, Grégory Verhoest, Richard Zigeuner, Vincenzo Ficarra, et al.. 2009. “Prognostic Value of Renal Vein and Inferior Vena Cava Involvement in Renal Cell Carcinoma”. European Urology. Elsevier BV. doi:10.1016/j.eururo.2008.07.053.
~1 spots leftby Apr 2025
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