Phase I study of Relapsed / Refractory Multiple Myeloma

NCT03269136

Last updated date
Study Location
UCSD Medical Center - Encinitas
Encinitas, California, 92024, United States
Contact
1-800-718-1021

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Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

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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

- Relapsed/refractory multiple myeloma

- Progressed or are intolerant of established therapies including proteasome inhibitor, immunomodulatory drug, and anti-CD38 antibody

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

- Adequate bone marrow, hematological, kidney and liver function

- Resolved acute effects of any prior therapy to baseline severity

- Not pregnant

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


- Recent history of other malignancies


- History of active autoimmune disorders


- Any form of primary immunodeficiency


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


- Evidence of active mucosal or internal bleeding


- History of severe immune-mediated adverse event with prior immunomodulatory treatment


- Major surgery within 4 weeks of study treatment start


- Radiation therapy within 2 weeks of study treatment start


- History of stem cell transplant (autologous or allogeneic) within 100 days prior to
study enrollment


- Donor Lymphocyte Infusion (DLI) within 30 days prior to study entry


- Less than 30 days since last dose of antibody based therapies or less than 5
half-lives since last dose of previous therapy


- Requirement for systemic immune suppressive medication


- Current requirement for chronic blood product support

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

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Advanced Information
Descriptive Information
Brief Title  ICMJE Phase 1 Study Of PF-06863135, A BCMA- CD3 Bispecific Ab, As A Single Agent And In Combination With Either PF-06801591 Or Lenalidomide 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, AS A SINGLE AGENT AND IN COMBINATION WITH EITHER PF-06801591 OR LENALIDOMIDE IN PATIENTS WITH RELAPSED/REFRACTORY ADVANCED MULTIPLE MYELOMA (MM)
Brief Summary 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.
Detailed Description 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Multiple Myeloma
Intervention  ICMJE
  • Drug: PF-06863135 monotherapy IV or SC
    PF-06863135 will be administered intravenously or subcutaneously.
  • Drug: PF-06863135 + PF-06801591
    PF-06863135 will be administered intravenously or subcutaneously.
  • Drug: PF-06863135 + lenalidomide
    PF-06863135 will be administered intravenously or subcutaneously.
Study Arms  ICMJE
  • Experimental: PF-06863135
    BCMA-CD3 bispecific antibody
    Intervention: Drug: PF-06863135 monotherapy IV or SC
  • Experimental: PF-06863135 + PF-06801591
    BCMA-CD3 bispecific antibody + anti-PD-1
    Intervention: Drug: PF-06863135 + PF-06801591
  • Experimental: PF-06863135 + lenalidomide
    BCMA-CD3 bispecific antibody + lenalidomide
    Intervention: Drug: PF-06863135 + lenalidomide
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 March 21, 2023
Estimated Primary Completion Date March 21, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Relapsed/refractory multiple myeloma
  • Progressed or are intolerant of established therapies including proteasome inhibitor, immunomodulatory drug, and anti-CD38 antibody
  • Performance Status of 0- 2 (unless due to bone pain)
  • Adequate bone marrow, hematological, kidney and liver function
  • Resolved acute effects of any prior therapy to baseline severity
  • Not pregnant

Exclusion Criteria:

  • Recent history of other malignancies
  • History of active autoimmune disorders
  • Any form of primary immunodeficiency
  • Active and clinically significant bacterial, fungal, or viral infection
  • Evidence of active mucosal or internal bleeding
  • History of severe immune-mediated adverse event with prior immunomodulatory treatment
  • Major surgery within 4 weeks of study treatment start
  • Radiation therapy within 2 weeks of study treatment start
  • History of stem cell transplant (autologous or allogeneic) within 100 days prior to study enrollment
  • Donor Lymphocyte Infusion (DLI) within 30 days prior to study entry
  • Less than 30 days since last dose of antibody based therapies or less than 5 half-lives since last dose of previous therapy
  • Requirement for systemic immune suppressive medication
  • Current requirement for chronic blood product support
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 Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03269136
Other Study ID Numbers  ICMJE C1071001
Has Data Monitoring Committee No
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/d….
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date July 2020

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