Pembrolizumab in Treating Patients With Intermediate or High-Risk Smoldering Multiple Myeloma
Pilot Single Arm, Single Center, Open Label Trial of Pembrolizumab in Patients With Intermediate and High Risk Smoldering Multiple Myeloma
2 other identifiers
interventional
20
1 country
1
Brief Summary
This pilot early phase I trial studies pembrolizumab in treating patients with slow growing (smoldering) multiple myeloma with intermediate or high-risk of spreading. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for early_phase_1
Started Jul 2016
Longer than P75 for early_phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 11, 2015
CompletedFirst Posted
Study publicly available on registry
November 13, 2015
CompletedStudy Start
First participant enrolled
July 20, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2017
CompletedResults Posted
Study results publicly available
March 20, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2027
ExpectedJanuary 29, 2026
January 1, 2026
1.4 years
November 11, 2015
February 7, 2020
January 13, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Overall Response Rate (ORR)
Overall response rate is defined as patients who have achieved partial response or higher as described per IMWG criteria for multiple myeloma after 8 cycles of therapy with pembrolizumab. Will be measured according to International Myeloma Working Group Criteria (IMWG) criteria. Response rate will be estimated accordingly. Each cycle has a duration of 21 days.
From cycle 1 to cycle 8, up to 168 days
Secondary Outcomes (3)
Number of Participants That Had Progression to Multiple Myeloma
At 30 months from study entry
Clinical Benefit Rate
From cycle 1 to cycle 8, up to 168 days
Overall Survival
Time of start of treatment to death from any cause up to 2 years and 6 months
Study Arms (1)
Treatment (pembrolizumab)
EXPERIMENTALPatients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.
Interventions
Given IV
Eligibility Criteria
You may not qualify if:
- Patients must have histologically confirmed SMM based on the following criteria:
- (A) Mayo clinic criteria (patient must have at least 2 risk factors present):
- \. Bone marrow core biopsy plasma cell involvement by cluster of differentiation (CD)138 immunohistochemistry \>= 10%
- \. Monoclonal spike \>= 3 g/dL
- \. Free light chain ratio in serum \< 0.125 or \> 8; \*2 of 3 risk factors: intermediate risk for progression at a rate of 51% at 5 years, \*3 of 3 risk factors: high risk for progression at a rate of 76% at 5 years
- OR (B) Programa para el Tratamiento de Hemopatias Malignas (PETHEMA) criteria (patient must have at least 1 risk factor present)
- \. \>= 95% abnormal plasma cells/total plasma cells in bone marrow compartment
- \. Immunoparesis \*1 of 2 risk factors: intermediate risk for progression at a rate of 46% at 5 years, \*2 of 2 risk factors: high risk for progression at a rate of 72% at 5 years
- OR (C) Southwestern Oncology Group (SWOG) criteria (patient must have 2 risk factors present or one risk factor if this risk factor is a 70-gene signature (GEP70) score of \> 37.2)
- \. Monoclonal spike \>= 3 g/dL
- \. Involved free light chain \>= 25 mg/dL
- \. GEP70 risk score \> 37.2 \*\>= 2 risk factors: high risk of progression at a rate of 70% at 2 years\*; we would also include patients with 1 risk factor as long as this risk factor is GEP70 risk score \> 37.2 since patients with this risk factor have an intermediate risk of progression at a rate of 50% at 2 years
- Creatinine clearance \>= 50 ml/min; creatinine clearance (CrCl) will be calculated by Cockcroft-Gault method
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Absolute neutrophil count (ANC) \>= 1.0 x 10\^9 /L
- +35 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- National Cancer Institute (NCI)collaborator
- M.D. Anderson Cancer Centerlead
Study Sites (1)
M D Anderson Cancer Center
Houston, Texas, 77030, United States
Related Publications (1)
Manasanch EE, Han G, Mathur R, Qing Y, Zhang Z, Lee H, Weber DM, Amini B, Berkova Z, Eterovic K, Zhang S, Zhang J, Song X, Mao X, Morgan M, Feng L, Baladandayuthapani V, Futreal A, Wang L, Neelapu SS, Orlowski RZ. A pilot study of pembrolizumab in smoldering myeloma: report of the clinical, immune, and genomic analysis. Blood Adv. 2019 Aug 13;3(15):2400-2408. doi: 10.1182/bloodadvances.2019000300.
PMID: 31405950DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Elisabet Manasanch/ Assistant Professor, Lymphoma-Myeloma
- Organization
- UT MD Anderson Cancer Center
Study Officials
- PRINCIPAL INVESTIGATOR
Neeraj Saini, MD
M.D. Anderson Cancer Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 11, 2015
First Posted
November 13, 2015
Study Start
July 20, 2016
Primary Completion
December 30, 2017
Study Completion (Estimated)
December 31, 2027
Last Updated
January 29, 2026
Results First Posted
March 20, 2020
Record last verified: 2026-01