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History of Changes for Study: NCT02576977
Study of Pomalidomide and Low Dose Dexamethasone With or Without Pembrolizumab (MK-3475) in Refractory or Relapsed and Refractory Multiple Myeloma (rrMM) (MK-3475-183/KEYNOTE-183)
Latest version (submitted September 13, 2021) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 October 14, 2015 None (earliest Version on record)
2 October 30, 2015 Recruitment Status, Contacts/Locations and Study Status
3 December 16, 2015 Study Status and Contacts/Locations
4 December 31, 2015 Contacts/Locations and Study Status
5 February 2, 2016 Study Status
6 February 11, 2016 Contacts/Locations and Study Status
7 February 17, 2016 Contacts/Locations and Study Status
8 March 3, 2016 Study Status and Contacts/Locations
9 March 9, 2016 Contacts/Locations and Study Status
10 March 15, 2016 Outcome Measures, Arms and Interventions, Study Status, Contacts/Locations, Eligibility, Study Description and Study Identification
11 April 1, 2016 Study Status and Contacts/Locations
12 April 7, 2016 Contacts/Locations and Study Status
13 April 28, 2016 Contacts/Locations and Study Status
14 May 5, 2016 Study Status and Contacts/Locations
15 May 13, 2016 Contacts/Locations and Study Status
16 May 20, 2016 Contacts/Locations and Study Status
17 June 1, 2016 Contacts/Locations, Study Status, Eligibility and Study Identification
18 June 16, 2016 Contacts/Locations and Study Status
19 June 22, 2016 Contacts/Locations and Study Status
20 August 3, 2016 Study Status and Contacts/Locations
21 August 10, 2016 Contacts/Locations and Study Status
22 August 25, 2016 Contacts/Locations and Study Status
23 September 1, 2016 Contacts/Locations and Study Status
24 February 3, 2017 Contacts/Locations and Study Status
25 February 7, 2017 Study Status
26 February 23, 2017 Study Status and Contacts/Locations
27 March 8, 2017 Study Status and Contacts/Locations
28 April 3, 2017 Study Status
29 May 4, 2017 Contacts/Locations and Study Status
30 May 18, 2017 Contacts/Locations and Study Status
31 June 8, 2017 Contacts/Locations and Study Status
32 June 16, 2017 Recruitment Status, Contacts/Locations and Study Status
33 September 6, 2017 Study Status and Contacts/Locations
34 April 13, 2018 Recruitment Status, Study Status and Contacts/Locations
35 February 26, 2019 Study Status, Study Design, IPDSharing and Eligibility
36 March 11, 2019 Study Status and Study Design
37 July 8, 2019 Outcome Measures, Study Status, Oversight, Document Section, Results, Study Description and Study Identification
38 February 21, 2020 Study Status and References
39 March 6, 2020 Study Status
40 July 15, 2020 Recruitment Status and Study Status
41 August 27, 2020 Study Status
42 December 2, 2020 Recruitment Status and Study Status
43 February 12, 2021 Study Status and More Information
44 September 13, 2021 Adverse Events, Outcome Measures, Participant Flow, Document Section, Study Status, More Information and Baseline Characteristics
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Study NCT02576977
Submitted Date:  October 14, 2015 (v1)

Open or close this module Study Identification
Unique Protocol ID: 3475-183
Brief Title: Study of Pomalidomide and Low Dose Dexamethasone With or Without Pembrolizumab (MK-3475) in Refractory or Relapsed and Refractory Multiple Myeloma (rrMM) (MK-3475-183/KEYNOTE-183)
Official Title: A Phase III Study of Pomalidomide and Low Dose Dexamethasone With or Without Pembrolizumab (MK3475) in Refractory or Relapsed and Refractory Multiple Myeloma (rrMM). (KEYNOTE 183)
Secondary IDs: 2015-002509-13 [EudraCT Number]
Open or close this module Study Status
Record Verification: October 2015
Overall Status: Not yet recruiting
Study Start: October 2015
Primary Completion: June 2017 [Anticipated]
Study Completion: April 2018 [Anticipated]
First Submitted: October 14, 2015
First Submitted that
Met QC Criteria:
October 14, 2015
First Posted: October 15, 2015 [Estimate]
Last Update Submitted that
Met QC Criteria:
October 14, 2015
Last Update Posted: October 15, 2015 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Merck Sharp & Dohme LLC
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: Yes
Open or close this module Study Description
Brief Summary: The purpose of this study is to compare the efficacy of pomalidomide and low dose dexamethasone with pembrolizumab (MK-3475) to that of pomalidomide and low dose dexamethasone without pembrolizumab in terms of progression-free survival (PFS) in participants with refractory or relapsed and refractory multiple myeloma (rrMM) who have undergone at least 2 lines of prior treatment.
Detailed Description:
Open or close this module Conditions
Conditions: Multiple Myeloma
Keywords: PDL1
PD1
Multiple Myeloma
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 3
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: None (Open Label)
Allocation: Randomized
Enrollment: 300 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Pembrolizumab+Pomalidomide+Dexamethasone
Participants receive pembrolizumab 200 mg intravenously (IV) on Day 1 every 3 weeks (Q3W) PLUS pomalidomide 4 mg orally (PO) on Days 1 to 21 of each 28-day cycle PLUS dexamethasone 40 mg PO on Days 1, 8, 15 and 22 of each 28-day cycle.
Biological: Pembrolizumab
pembrolizumab IV infusion
Drug: Pomalidomide
pomalidomide capsules
Drug: Dexamethasone
dexamethasone tablets
Active Comparator: Pomalidomide+Dexamethasone
Participants receive pomalidomide 4 mg PO on Days 1 to 21 of each 28-day cycle PLUS dexamethasone 40 mg PO on Days 1, 8, 15 and 22 of each 28-day cycle.
Drug: Pomalidomide
pomalidomide capsules
Drug: Dexamethasone
dexamethasone tablets
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Progression Free Survival (PFS)
[ Time Frame: Up to 33 months ]

Secondary Outcome Measures:
1. Overall Survival (OS)
[ Time Frame: Up to 33 months ]

Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  • Has a confirmed diagnosis of active multiple myeloma and measurable disease.
  • Must have undergone prior treatment with ≥2 treatment lines of anti-myeloma therapy and must have failed last line of treatment (refractory to last line of treatment).
  • Prior anti-myeloma treatments must have included an immunomodulatory drug (IMiD) AND proteasome inhibitor alone or in combination and participant must have failed therapy with an IMiD OR proteasome inhibitor.
  • Has performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale.

Exclusion Criteria:

  • Has had prior anti-myeloma therapy within 2 weeks prior to study Day 1 and has not recovered (i.e., ≤ Grade 1 or at Baseline) from adverse events due to a previously administered agent.
  • Has undergone prior allogeneic hematopoetic stem cell transplantation within the last 5 years. (Participants who have had a transplant greater than 5 years ago are eligible as long as there are no symptoms of Graft versus Host Disease [GVHD]).
  • Has received autologous stem cell transplant (auto-SCT) within 12 weeks before the first infusion or is planning for or is eligible for auto-SCT.
  • Has received previous therapy with pomalidomide.
  • Has peripheral neuropathy ≥ Grade 2.
  • Has a known additional malignancy that is progressing or requires active treatment (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 evidence of active, non-infectious pneumonitis.
  • Has received prior therapy with an anti-programmed cell death 1 receptor (anti-PD-1), antiprogrammed 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 costimulation or checkpoint pathways).
Open or close this module Contacts/Locations
Study Officials: Medical Director
Study Director
Merck Sharp & Dohme LLC
Locations:
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:

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