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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)

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ClinicalTrials.gov Identifier: NCT02579863
Recruitment Status : Active, not recruiting
First Posted : October 20, 2015
Last Update Posted : April 17, 2018
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
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 or disease Intervention/treatment Phase
Multiple Myeloma Drug: lenalidomide Drug: dexamethasone Biological: pembrolizumab Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 640 participants
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).
Actual Study Start Date : October 19, 2015
Estimated Primary Completion Date : August 30, 2019
Estimated Study Completion Date : September 30, 2020


Arm Intervention/treatment
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




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

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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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.

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


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Director Merck Sharp & Dohme Corp.

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 Posted: October 20, 2015    Key Record Dates
Last Update Posted: April 17, 2018
Last Verified: April 2018

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
Pembrolizumab
Lenalidomide
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