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Phase I study of Relapsed / Refractory Multiple Myeloma

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NCT03269136

Last updated on November 19, 2019
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FOR MORE INFORMATION
Study Location
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242 United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Multiple Myeloma
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Patients with relapse/ refractory multiple myeloma

- Performance Status of 0- 2 (unless due to bone pain)

- Adequate bone marrow, kidney and liver function

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- History of active autoimmune disorders

- Active and clinically significant bacterial, fungal, or viral infection

- Major surgery within 4 weeks of study treatment start

- Radiation therapy within 2 weeks of study treatment start

- Less than 30 days since last dose of anti CD38 therapy, elotuzumab or other anti-CD319
therapy or less than 5 half-lives since last dose of previous systemic therapy.

- Stem cell transplant (autologous or allogeneic) within 100 days of study treatment
start

Trial Details
Administration
The form in which the study drug will be delivered to the patient's body.
Intravenous injections
Subcutaneous injections
Placebo
A placebo often looks like the investigational medication, but it has no active ingredient in it.
A placebo is not used in this trial
Duration
The time commitment for participation in the study.
Follow up: 4 weeks
Screening: Range 2 weeks
Treatment: Range 4 weeks
Site Visits
Follow up: 1 visits
Screening: Up to 2 visits
Treatment: Up to 10 visits
Prior Approval
The study drug has not been approved yet.
Post-Trial Access to Study Drug
Not planned
Trial Procedures
Biopsy
Blood test
Electrocardiogram (ECG)
Physical examination
Urine test
Vital signs and measurements
Other
NCT03269136
Pfizer
Recruiting
Phase I study of Relapsed / Refractory Multiple Myeloma

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Multiple Myeloma
Phase I study of Relapsed / Refractory Multiple Myeloma
NCT03269136
All Genders
18+
Years
Multiple Sites
Descriptive Information
Brief Title  ICMJE Phase 1 Study Of PF-06863135, A BCMA- CD3 Bispecific Ab, In Relapse/ Refractory Multiple Myeloma
Official Title  ICMJE A PHASE I, OPEN LABEL STUDY TO EVALUATE THE SAFETY, PHARMACOKINETIC, PHARMACODYNAMIC AND CLINICAL ACTIVITY OF PF-06863135, A B-CELL MATURATION ANTIGEN (BCMA)-CD3 BISPECIFIC ANTIBODY, IN PATIENTS WITH RELAPSED/REFRACTORY ADVANCED MULTIPLE MYELOMA (MM)
Brief SummaryTo assess the safety and tolerability at increasing dose levels of PF-06863135 in patients with relapse/ refractory multiple myeloma in order to determine the maximum tolerated dose and select the recommended Phase 2 dose.
Detailed DescriptionStudy C1071001 is a Phase 1, open label, multi dose, multi center, dose escalation, safety, pharmacokinetic (PK) and pharmacodynamic study of PF-06863135 in adult patients with advanced multiple myeloma who have relapsed from or are refractory to standard therapy. This two part study will assess the safety and tolerability of increasing dose levels of PF-06863135 in Part 1, and establish the recommended Phase 2 dose (RP2D) in Part 2.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Multiple Myeloma
Intervention  ICMJE
  • Drug: PF-06863135
    PF 06863135 will be administered intravenously. Increases in dose will continue until MTD is determined.
  • Drug: PF-06863135
    PF-06863135 will be administered subcutaneously. Increases in dose will continue until MTD is determined.
Study Arms  ICMJE Experimental: PF-06863135
BCMA-CD3 bispecific antibody
Interventions:
  • Drug: PF-06863135
  • Drug: PF-06863135
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 27, 2017)		80
Original Estimated Enrollment  ICMJE
 (submitted: August 29, 2017)		140
Estimated Study Completion Date  ICMJE June 15, 2022
Estimated Primary Completion DateDecember 28, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients with relapse/ refractory multiple myeloma
  • Performance Status of 0- 2 (unless due to bone pain)
  • Adequate bone marrow, kidney and liver function

Exclusion Criteria:

  • History of active autoimmune disorders
  • Active and clinically significant bacterial, fungal, or viral infection
  • Major surgery within 4 weeks of study treatment start
  • Radiation therapy within 2 weeks of study treatment start
  • Less than 30 days since last dose of anti CD38 therapy, elotuzumab or other anti-CD319 therapy or less than 5 half-lives since last dose of previous systemic therapy.
  • Stem cell transplant (autologous or allogeneic) within 100 days of study treatment start
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Pfizer CT.gov Call Center1-800-718-1021[email protected]
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03269136
Other Study ID Numbers  ICMJE C1071001
Has Data Monitoring CommitteeNo
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product:Yes
Studies a U.S. FDA-regulated Device Product:No
IPD Sharing Statement  ICMJE
Plan to Share IPD:No
Plan Description: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/da....
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateSeptember 2019

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

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