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Phase I study of Relapsed / Refractory Multiple Myeloma

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NCT03269136

Last updated on December 6, 2018
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FOR MORE INFORMATION
Study Location
The University of Chicago Medical Center, CCD - Investigational Drug Service Pharmacy
Chicago, Illinois, 60637 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.
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
Treatment: Range 4 weeks
Screening: Range 2 weeks
Site Visits
Follow up: 1 visits
Treatment: Up to 10 visits
Screening: Up to 2 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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Pfizer Clinical Trials Contact Center

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[email protected]

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Phase 1 Study Of PF-06863135, A BCMA- CD3 Bispecific Ab, In Relapse/ Refractory Multiple Myeloma
A Phase I, Open Label Study to Evaluate the Safety, Pharmacokinetic, Pharmacodynamic and Clinical Activity of PF-06863135, a BCMA-CD3 Bispecific Antibody, in Patients With Relapsed/Refractory Advanced Multiple Myeloma.
To 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.
Study 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.
Interventional
Phase 1
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Multiple Myeloma
Drug: PF-06863135
PF 06863135 will be administered intravenously. Increases in dose will continue until MTD is determined.
Experimental: PF-06863135
BCMA-CD3 bispecific antibody
Intervention: Drug: PF-06863135
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
80
December 6, 2021
March 27, 2021   (Final data collection date for primary outcome measure)

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 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
Sexes Eligible for Study: All
18 Years to 69 Years   (Adult, Senior)
No

Contact: Pfizer CT.gov Call Center 1-800-718-1021 [email protected]
Not Provided
 
 
NCT03269136
C1071001
No
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
Plan Description: Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/da...
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
November 2017

ICMJE     Data element required by the

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

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

Call Now