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Study of Lenalidomide and Dexamethasone With or Without Pembrolizumab (MK-3475) in Participants With Newly Diagnosed Treatment Naive Multiple Myeloma (MK-3475-185/KEYNOTE-185)

This study has suspended participant recruitment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02579863
First Posted: October 20, 2015
Last Update Posted: July 31, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
  Purpose
The purpose of this study is to compare the efficacy of lenalidomide and low dose dexamethasone with pembrolizumab (MK-3475) to that of lenalidomide and low dose dexamethasone without pembrolizumab in terms of progression-free survival (PFS) in participants with newly diagnosed and treatment-naïve multiple myeloma who are ineligible for autologous stem cell transplant (Auto-SCT).

Condition Intervention Phase
Multiple Myeloma Drug: lenalidomide Drug: dexamethasone Biological: pembrolizumab Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase III Study of Lenalidomide and Low-dose Dexamethasone With or Without Pembrolizumab (MK3475) in Newly Diagnosed and Treatment naïve Multiple Myeloma (KEYNOTE 185).

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Progression Free Survival (PFS) [ Time Frame: Up to 41 months ]

Secondary Outcome Measures:
  • Overall Survival (OS) [ Time Frame: Up to 41 months ]

Estimated Enrollment: 640
Actual Study Start Date: October 19, 2015
Estimated Study Completion Date: July 31, 2021
Estimated Primary Completion Date: August 31, 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Lenolidomide + dexamethasone
Participants receive lenalidomide 25 mg orally (PO) on Days 1 to 21 of each treatment cycle, and dexamethasone 40 mg PO weekly
Drug: lenalidomide
25 mg administered orally (PO) on Days 1 to 21 of each treatment cycle
Drug: dexamethasone
40 mg administered orally (PO) on Days 1, 8, 15, and 22 of each treatment cycle
Experimental: Pembrolizumab + lenalidomide + dexamethasone
Participants receive pembrolizumab 200 mg intravenously (IV) on Day 1 every 3 weeks (Q3W), lenalidomide 25 mg PO on Days 1 to 21 of each treatment cycle, and dexamethasone 40 mg PO weekly
Drug: lenalidomide
25 mg administered orally (PO) on Days 1 to 21 of each treatment cycle
Drug: dexamethasone
40 mg administered orally (PO) on Days 1, 8, 15, and 22 of each treatment cycle
Biological: pembrolizumab
200 mg administered as an intravenous (IV) infusion on Day 1 every 3 weeks

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Confirmed diagnosis of active multiple myeloma and measurable disease.
  • Ineligible to receive treatment with auto-SCT due to age (≥65 years old) or any significant coexisting medical condition (cardiac, renal, pulmonary or hepatic dysfunction), likely to have a negative impact on tolerability of auto-SCT. Participants <65 years of age who refuse auto-SCT are not eligible for this study.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
  • Female participants of childbearing potential must have 2 negative urine pregnancy tests (with a sensitivity of at least 25 Milli-international units/Milliliter) within 10 to 14 days and within 24 hours prior to receiving study medication.
  • Female participants of childbearing potential must agree to use adequate contraception 28 days prior to study start, continuing throughout the study, and for up to 28 days after the last dose of lenalidomide (or 120 days after the last dose of pembrolizumab).
  • Male participants of childbearing potential must agree to use adequate contraception from the first dose of study medication, continuing throughout the study, and for up to 28 days after the last dose of lenalidomide (or 120 days after the last dose of pembrolizumab).

Exclusion Criteria:

  • Has undergone prior allogeneic hematopoetic stem cell transplantation within the last 5 years.
  • Has peripheral neuropathy ≥ Grade 2.
  • Has a known additional malignancy that is progressing or requires active treatment within the last 5 years (except for basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy).
  • Has history of non-infectious pneumonitis that required steroids or current pneumonitis
  • Has received prior therapy with an anti-programmed cell death 1 receptor (anti-PD-1), anti-programmed death-ligand 1 (anti-PD-L1), anti-PD-L2, anti-CD137, or anti-cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways).
  • Has a known Human Immunodeficiency Virus (HIV), or a known, active Hepatitis B (HBV), or a known, active Hepatitis C (HCV) infection.
  • Is unable or unwilling to undergo thromboembolic prophylaxis including, as clinically indicated, aspirin, Coumadin (warfarin) or low-molecular weight heparin.
  • Has lactose intolerance.
  • Has an invasive fungal infection.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02579863


  Show 75 Study Locations
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Director Merck Sharp & Dohme Corp.
  More Information

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT02579863     History of Changes
Other Study ID Numbers: 3475-185
2015-002901-12 ( EudraCT Number )
163239 ( Registry Identifier: JAPIC-CTI )
First Submitted: October 16, 2015
First Posted: October 20, 2015
Last Update Posted: July 31, 2017
Last Verified: July 2017

Keywords provided by Merck Sharp & Dohme Corp.:
PD1
PD-1
PD-L1
PDL1

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone acetate
Dexamethasone
Lenalidomide
Pembrolizumab
Thalidomide
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal