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Phase 2 Completed N=11 Treatment

Pembrolizumab, Lenalidomide, and Dexamethasone in Treating Patients With Newly Diagnosed Multiple Myeloma Eligible for Stem Cell Transplant

Source: ClinicalTrials.gov NCT02880228 ↗
Enrolled (actual)
11
Serious AEs
27.3%
Results posted
Jul 2019
Primary outcomePrimary: Proportion of Complete Response Plus Very Good Partial Response (VGPR) — 0 proportion of participants

Summary

This phase II trial studies how well pembrolizumab, lenalidomide, and dexamethasone work in treating patients with newly diagnosed multiple myeloma that are eligible for stem cell transplant. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as lenalidomide and dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving pembrolizumab, lenalidomide, and dexamethasone may work better in treating patients with multiple myeloma.

Outcome Measures

OutcomeResultp-value
PRIMARY
Proportion of Complete Response Plus Very Good Partial Response (VGPR)
SECONDARY
Progression-free Survival
NA
SECONDARY
Partial Response (PR)
SECONDARY
Proportion of Successful Stem Cell Collection
0.4
SECONDARY
Survival Time
NA

Eligibility Criteria

Inclusion Criteria

  • Diagnosis and previously untreated active multiple myeloma by International Myeloma Working Group (IMWG) diagnostic criteria for multiple myeloma
  • Calculated creatinine clearance (using Cockcroft-Gault equation) >= 30 mL/min
  • Absolute neutrophil count (ANC) >= 1000/mm^3
  • Platelet count >= 75000/mm^3
  • Hemoglobin >= 8.0 g/dL
  • Total bilirubin = 7 days should have elapsed from the last day of radiation
  • NOTE: Prior therapy with clarithromycin, dehydroepiandrosterone (DHEA), anakinra, pamidronate, or zoledronic acid is permitted; any additional agents not listed must be approved by the principal investigator
  • Measurable disease of multiple myeloma as defined by at least ONE of the following:
  • Serum monoclonal protein >= 1.0 g/dL
  • > 200 mg of monoclonal protein in the urine on 24 hour electrophoresis
  • Serum immunoglobulin free light chain >= 10 mg/dL AND abnormal serum immunoglobulin kappa to lambda free light chain ratio
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
  • Provide written informed consent
  • Negative pregnancy test done = = grade 3 on clinical examination or grade 2 with pain during the screening period
  • Major surgery =< 14 days prior to study registration
  • Radiotherapy =< 14 days prior to registration
  • NOTE: If the involved field is small, 7 days will be considered a sufficient interval between treatment and administration of study drugs
  • Participation in any other clinical trials with other investigational agents not included in this trial, =< 21 days prior to registration
  • Active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids, or immunosuppressive drugs)
  • NOTE: Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment
  • Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis
  • Active infection requiring systemic therapy
  • History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator
  • Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
  • Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment
  • Received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent
  • Known history of human immunodeficiency virus (HIV) (HIV 1/2 antibodies)
  • Known active hepatitis B (e.g., hepatitis B surface antigen [HBsAg] reactive) or hepatitis C (e.g., hepatitis C virus [HCV] ribonucleic acid [RNA] [qualitative] is detected)
  • Received a live vaccine =< 30 days of planned start of study therapy
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02880228). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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