ClinicalTrials.gov

History of Changes for Study: NCT04649359
Study of PF-06863135 Monotherapy in Participants With Multiple Myeloma Who Are Refractory to at Least One PI, One IMiD and One Anti-CD38 mAb (Elemmental-3)
Latest version (submitted June 7, 2022) on ClinicalTrials.gov
  • A study version is represented by a row in the table.
  • Select two study versions to compare. One each from columns A and B.
  • Choose either the "Merged" or "Side-by-Side" comparison format to specify how the two study versions are to be displayed. The Side-by-Side format only applies to the Protocol section of the study.
  • Click "Compare" to do the comparison and show the differences.
  • Select a version's Submitted Date link to see a rendering of the study for that version.
  • The yellow A/B choices in the table indicate the study versions currently compared below. A yellow table row indicates the study version currently being viewed.
  • Hover over the "Recruitment Status" to see how the study's recruitment status changed.
  • Study edits or deletions are displayed in red.
  • Study additions are displayed in green.
Study Record Versions
Version A B Submitted Date Changes
1 November 24, 2020 None (earliest Version on record)
2 December 17, 2020 Study Status, Conditions and Study Identification
3 December 23, 2020 Study Status and Contacts/Locations
4 February 8, 2021 Study Status, Eligibility, Contacts/Locations, Outcome Measures, Conditions and Study Identification
5 February 11, 2021 Recruitment Status, Study Status, Contacts/Locations and Study Identification
6 March 18, 2021 Contacts/Locations and Study Status
7 April 7, 2021 Study Status, Contacts/Locations and Study Identification
8 May 19, 2021 Recruitment Status, Contacts/Locations, Study Status, Study Design and Study Identification
9 May 31, 2021 Arms and Interventions, Study Status, Outcome Measures, Eligibility and Study Description
10 June 9, 2021 Study Design and Study Status
11 June 10, 2021 Recruitment Status, Study Status and Contacts/Locations
12 July 7, 2021 Study Status and Contacts/Locations
13 July 29, 2021 Contacts/Locations and Study Status
14 August 3, 2021 Study Status and Contacts/Locations
15 August 10, 2021 Contacts/Locations and Study Status
16 August 16, 2021 Contacts/Locations and Study Status
17 September 9, 2021 Study Status and Contacts/Locations
18 September 10, 2021 Contacts/Locations and Study Status
19 September 21, 2021 Contacts/Locations and Study Status
20 September 27, 2021 Contacts/Locations and Study Status
21 October 4, 2021 Contacts/Locations and Study Status
22 October 8, 2021 Contacts/Locations and Study Status
23 October 14, 2021 Contacts/Locations and Study Status
24 October 18, 2021 Contacts/Locations and Study Status
25 October 26, 2021 Contacts/Locations and Study Status
26 November 3, 2021 Contacts/Locations and Study Status
27 November 12, 2021 Contacts/Locations and Study Status
28 November 18, 2021 Contacts/Locations and Study Status
29 December 2, 2021 Contacts/Locations and Study Status
30 December 16, 2021 Outcome Measures, Contacts/Locations, Study Design and Study Status
31 January 10, 2022 Contacts/Locations and Study Status
32 January 28, 2022 Recruitment Status, Contacts/Locations and Study Status
33 April 14, 2022 Study Status, Contacts/Locations and Study Identification
34 June 7, 2022 Study Status, Study Design and Contacts/Locations
Comparison Format:

Scroll up to access the controls

Study NCT04649359
Submitted Date:  November 24, 2020 (v1)

Open or close this module Study Identification
Unique Protocol ID: C1071003
Brief Title: Study of PF-06863135 Monotherapy in Participants With Multiple Myeloma Who Are Refractory to at Least One PI, One IMiD and One Anti-CD38 mAb (Elemmental-3)
Official Title: AN OPEN-LABEL, MULTICENTER, NON-RANDOMIZED PHASE 2 STUDY OF PF-06863135 MONOTHERAPY IN PARTICIPANTS WITH MULTIPLE MYELOMA WHO ARE REFRACTORY TO AT LEAST ONE PROTEASOME INHIBITOR, ONE IMMUNOMODULATORY DRUG AND ONE ANTI-CD38 ANTIBODY
Secondary IDs:
Open or close this module Study Status
Record Verification: November 2020
Overall Status: Not yet recruiting
Study Start: January 7, 2021
Primary Completion: June 25, 2022 [Anticipated]
Study Completion: October 17, 2026 [Anticipated]
First Submitted: November 6, 2020
First Submitted that
Met QC Criteria:
November 24, 2020
First Posted: December 2, 2020 [Actual]
Last Update Submitted that
Met QC Criteria:
November 24, 2020
Last Update Posted: December 2, 2020 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Pfizer
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: Yes
Open or close this module Study Description
Brief Summary: The purpose of the study is to evaluate whether single-agent PF-06863135 can provide clinical benefit in participants with relapsed/refractory multiple myeloma. PF-06863135 is a bispecific antibody: binding of PF-06863135 to CD3-expressing T-cells and BCMA-expressing multiple myeloma cells causes targeted T-cell-mediated cytotoxicity.
Detailed Description:
Open or close this module Conditions
Conditions: Multiple Myeloma
Keywords: Elemmental-3
Elemmental
Myeloma
Multiple Myeloma
relapsed Multiple Myeloma
refractory Multiple Myeloma
PF-06863135
BCMA
bispecific
bispecific antibody
BCMA-CD3 bispecific
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 2
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: None (Open Label)
Allocation: Non-Randomized
Enrollment: 150 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: PF-06863135 (cohort A)
BCMA-CD3 bispecific antibody
Drug: PF-06863135
BCMA-CD3 bispecific antibody
Experimental: PF-06863135 (cohort B)
BCMA-CD3 bispecific antibody
Drug: PF-06863135
BCMA-CD3 bispecific antibody
Open or close this module Outcome Measures
Primary Outcome Measures:
1. objective response rate
[ Time Frame: assessed approximately every 4 weeks [up to approximately 2 years] ]

objective response rate (IMWG response criteria)
Secondary Outcome Measures:
1. duration of response
[ Time Frame: assessed approximately every 4 weeks [up to approximately 2 years] ]

duration of response (IMWG response criteria)
2. cumulative complete response rate
[ Time Frame: assessed approximately every 4 weeks [up to approximately 2 years] ]

cumulative complete response rate (IMWG response criteria)
3. duration of cumulative complete response
[ Time Frame: assessed approximately every 4 weeks [up to approximately 2 years] ]

duration of cumulative complete response (IMWG response criteria)
4. progression free survival
[ Time Frame: assessed approximately every 4 weeks [up to approximately 2 years] ]

progression free survival (IMWG response criteria)
5. time to response
[ Time Frame: assessed approximately every 4 weeks [up to approximately 2 years] ]

time to response (IMWG response criteria)
6. minimal residual disease negativity rate
[ Time Frame: assessed approximately every 12 months [up to approximately 2 years] ]

minimal residual disease negativity rate (IMWG response criteria)
7. frequency of treatment-emergent adverse events
[ Time Frame: up to approximately 2 years ]

type and severity (including severity per NCI CTCAE v5)
8. frequency of laboratory abnormalities
[ Time Frame: assessed at least approximately every cycle [each cycle approximately 28 days] ]

complete blood count and serum chemistry; type and severity of abnormalities (severity per NCI CTCAE v5)
9. concentrations of PF-06863135
[ Time Frame: assessed approximately every 1 to 3 cycles [each cycle approximately 28 days] ]

pharmacokinetics of PF-06863135
10. immunogenicity of PF-06863135
[ Time Frame: assessed approximately every 1 to 3 cycles [each cycle approximately 28 days] ]

immunogenicity of PF-06863135 (anti-drug antibodies against PF-06863135)
11. overall survival
[ Time Frame: up to approximately 5 years ]

Open or close this module Eligibility
Minimum Age: 16 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  • Diagnosis of multiple myeloma (IMWG criteria, Rajkumar et al, 2014)
  • Measurable disease, as defined by at least 1 of the following:
    1. Serum M-protein >0.5 g/dL by SPEP
    2. Urinary M-protein excretion >200 mg/24 hours by UPEP
    3. Serum immunoglobulin FLC≥10 mg/dL (≥100 mg/L) AND abnormal serum immunoglobulin kappa to lambda FLC ratio
  • Refractory to at least one IMiD
  • Refractory to at least one PI
  • Refractory to at least one anti-CD38 antibody
  • Relapsed/refractory to last anti-myeloma regimen
  • ECOG performance status ≤2
  • Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade ≤1
  • Not pregnant and willing to use contraception

Exclusion Criteria:

  • Smoldering multiple myeloma
  • Plasma cell leukemia
  • Light chain amyloidosis
  • Active HBV, HCV, SARS-CoV2, known HIV, or any active, uncontrolled bacterial, fungal, or viral infection
  • Any other active malignancy within 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ.
  • Previous administration with an investigational drug within 30 days or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer)
Open or close this module Contacts/Locations
Central Contact Person: Pfizer CT.gov Call Center
Telephone: 1-800-718-1021
Email: ClinicalTrials.gov_Inquiries@pfizer.com
Study Officials: Pfizer CT.gov Call Center
Study Director
Pfizer
Locations:
Open or close this module IPDSharing
Plan to Share IPD: Yes
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
Supporting Information:
Time Frame:
Access Criteria:
URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Open or close this module References
Citations:
Links: Description: To obtain contact information for a study center near you, click here.
Available IPD/Information:

Scroll up to access the controls Scroll to the Study top

U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services