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Corticosteroid

Pembrolizumab for Multiple Myeloma

Phase 2
Waitlist Available
Led By Yi Lin, M.D., Ph.D.
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Must have relapsed or refractory disease after treatments including three therapies: proteasome inhibitors, immunomodulatory imide drugs (IMiDs), and anti-CD38 antibody
Willing to provide bone marrow and blood samples for planned research
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights

Study Summary

This trial is testing pembrolizumab given with ixazomib citrate and dexamethasone to see if it is an effective treatment for relapsed multiple myeloma.

Eligible Conditions
  • Multiple Myeloma

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have a disease that has come back or has not responded to treatment after trying three different types of medications: proteasome inhibitors, immunomodulatory imide drugs (IMiDs), and anti-CD38 antibodies.
Select...
You are willing to give samples of bone marrow and blood for research purposes.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 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
Overall Response Percentage
Secondary outcome measures
>= Very Good Partial Response (VGPR) Response Percentage With Pembrolizumab Added to Ixazomib Citrate and Dexamethasone
Dexamethasone
Incidence of Adverse Events
+2 more
Other outcome measures
Markers of T-cell Activation and Exhaustion
Natural Killer Cells
Bone Marrow

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%
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: Treatment (ixazomib citrate, pembrolizumab, dexamethasone)Experimental Treatment4 Interventions
Patients receive ixazomib citrate PO on days 1, 8, 15, 29, 36, 43, 57, 64, and 71 and pembrolizumab IV over 30 minutes on days 1, 22, 43, 64. Patients also receive dexamethasone PO on days 1, 8, 15, 29, 36, 43, 57, 64, and 71. Cycles with dexamethasone repeat every 84 days for up to 1 year and cycles with ixazomib citrate and pembrolizumab repeat every 84 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~1950
Dexamethasone
2007
Completed Phase 4
~2590
Ixazomib Citrate
2012
Completed Phase 2
~200

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,176 Previous Clinical Trials
3,758,038 Total Patients Enrolled
75 Trials studying Multiple Myeloma
9,498 Patients Enrolled for Multiple Myeloma
National Cancer Institute (NCI)NIH
13,609 Previous Clinical Trials
40,915,633 Total Patients Enrolled
572 Trials studying Multiple Myeloma
187,972 Patients Enrolled for Multiple Myeloma
Yi Lin, M.D., Ph.D.Principal InvestigatorMayo Clinic

Frequently Asked Questions

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

In what contexts is Pembrolizumab commonly prescribed?

"Pembrolizumab is frequently used when tackling recurrent cervical cancer, but it may also be beneficial to those suffering from synovitis, refractory relapsed mediastinal large b-cell lymphoma and ophthalmia sympathetic."

Answered by AI

What is the ultimate aim of this clinical research project?

"This medical trial will span two years and evaluate outcomes such as the overall response rate, incidence of adverse events graded according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0., percentage with pembrolizumab added to ixazomib citrate and dexamethasone achieving a very good partial response (VGPR), complete response (CR) or stringent complete response (sCR), and survival time calculated using the method of Kaplan-Meier."

Answered by AI

What is the cumulative enrollment for this experimental program?

"At this juncture, the trial is not actively searching for participants. It was first posted on June 19th 2018 and last updated October 19th 2022. If you are seeking clinical trials involving multiple myeloma, there are currently 807 active studies recruiting patients; similarly 1528 medical research projects require Pembrolizumab enrollees."

Answered by AI

Has Pembrolizumab been accredited by the FDA?

"The risk posed by Pembrolizumab has been evaluated and rated as a 2, based on the evidence available from Phase 2 trials. This implies that while safety data is present, there is yet to be any supportive information in regards to efficacy."

Answered by AI

Are there any remaining opportunities for people to join this clinical research?

"As of October 19th 2022, this trial is no longer recruiting. Initially posted on June 19th 2018, it was most recently updated four years later. Nevertheless, 807 studies that are accepting participants with multiple myeloma and 1528 trials for Pembrolizumab remain active in recruitment."

Answered by AI
~2 spots leftby Mar 2025