ClinicalTrials.gov
ClinicalTrials.gov Menu

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)

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.
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.

October 16, 2015
October 20, 2015
April 17, 2018
October 19, 2015
August 30, 2019   (Final data collection date for primary outcome measure)
Progression Free Survival (PFS) [ Time Frame: Up to 41 months ]
Same as current
Complete list of historical versions of study NCT02579863 on ClinicalTrials.gov Archive Site
Overall Survival (OS) [ Time Frame: Up to 41 months ]
Same as current
Not Provided
Not Provided
 
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)
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).
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).
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Multiple Myeloma
  • 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
  • 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
    Interventions:
    • Drug: lenalidomide
    • Drug: dexamethasone
  • 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
    Interventions:
    • Drug: lenalidomide
    • Drug: dexamethasone
    • Biological: pembrolizumab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
640
Same as current
September 30, 2020
August 30, 2019   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
Australia,   Canada,   France,   Germany,   Ireland,   Israel,   Italy,   Japan,   New Zealand,   Norway,   Russian Federation,   South Africa,   Spain,   United Kingdom,   United States
 
NCT02579863
3475-185
2015-002901-12 ( EudraCT Number )
163239 ( Registry Identifier: JAPIC-CTI )
Yes
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Director Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP