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Clinical Trials/EUCTR2020-004533-21-ES
EUCTR2020-004533-21-ESActive, not recruitingPhase 1

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

Pfizer Inc.0 sites150 target enrollmentStarted: December 15, 2021Last updated:
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Conditions

Trial Snapshot

Phase
Phase 1
Status
Active, not recruiting
Enrollment
150
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

Inclusion Criteria

  • •Participants are eligible to be included in the study only if all of the following criteria apply:
  • •Age and Sex:
  • •1. Male or female participants age =18 years.
  • •A female participant is eligible to participate if she is not pregnant or
  • •breastfeeding. Refer to Appendix 4 for all reproductive criteria for male
  • •(Section 10.4.1) and female (Section 10.4.2) participants.
  • •Type of Participant and Disease Characteristics:
  • •2. Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
  • •3. Prior diagnosis of MM as defined according to IMWG criteria (Rajkumar et al, 2014).
  • •4. Measurable disease based on IMWG criteria as defined by at least 1 of the following:
  • •a. Serum M-protein >0.5 g/dL by SPEP
  • •b. Urinary M-protein excretion >200 mg/24 hours by UPEP
  • •c. Serum immunoglobulin FLC=10 mg/dL (=100 mg/L) AND abnormal serum
  • •immunoglobulin kappa to lambda FLC ratio (<0.26 or >1.65)
  • •5. Refractory to at least one IMiD.
  • •6. Refractory to at least one PI.
  • •7. Refractory to at least one anti-CD38 antibody.
  • •8. Relapsed/refractory to last anti-MM regimen.
  • •Note: Refractory is defined as having disease progression while on therapy or within
  • •60 days of last dose in any line, regardless of response.
  • •9. Cohort A: Has not received prior BCMA-directed therapy.
  • •Cohort B: Has received prior BCMA-directed ADC or BCMA-directed CAR T-cell
  • •therapy, either approved or investigational.
  • •10. ECOG performance status =2.
  • •11. LVEF =40% as determined by a MUGA scan or ECHO.
  • •12. Adequate hepatic function characterized by the following:
  • •a. Total bilirubin =2 x ULN (=3 x ULN if documented Gilbert’s syndrome);
  • •b. AST =2.5 x ULN; and
  • •c. ALT =2.5 x ULN
  • •13. Adequate renal function defined by an estimated creatinine clearance =30 mL/min (according to the Cockcroft Gault formula, by 24-hour urine collection for creatinine clearance, or according to local institutional standard method).
  • •14. Adequate BM function characterized by the following:
  • •a. ANC =1.0 × 10^9/L;
  • •b. Platelets =25 × 10^9/L; and
  • •c. Hemoglobin =8 g/dL
  • •15. Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade =1
  • •Informed Consent:
  • •16. Capable of giving signed informed consent as described in Appendix 1, which includes compliance with the requirements and restrictions listed in the ICD and in this protocol.
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1.2 Adults (18-64 years) yes
  • •F.1.2.1 Number of subjects for this age range 75
  • •F.1.3 Elderly (>=65 years) yes
  • •F.1.3.1 Number of subjects for this age range 75

Exclusion Criteria

  • •Participants are excluded from the study if any of the following criteria apply:
  • •Medical Conditions:
  • •1. Smoldering MM.
  • •2. Active Plasma cell leukemia.
  • •3. amyloidosis.
  • •4. Stem cell transplant within 30 days prior to enrollment or active GVHD.
  • •5. Impaired cardiovascular function or clinically significant cardiovascular diseases, defined as any of the following within 6 months prior to enrollment:
  • •a. Acute myocardial infarction or acute coronary syndromes (eg, unstable angina, coronary artery bypass graft, coronary angioplasty or stenting, symptomatic pericardial effusion);
  • •b. Clinically significant cardiac arrhythmias (eg, uncontrolled atrial fibrillation or uncontrolled paroxysmal supraventricular tachycardia);
  • •c. Thromboembolic or cerebrovascular events (eg, transient ischemic attack,
  • •cerebrovascular accident, deep vein thrombosis or pulmonary embolism);
  • •d. Prolonged QT syndrome (or triplicate average QTcF >470 msec at screening).
  • •6. Active HBV, HCV, SARS-CoV2, HIV, or any active, uncontrolled bacterial, fungal, or viral infection.
  • •7. 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.
  • •8.Other surgical (including major surgery within 14 days prior to enrollment), medical or psychiatric conditions including recent (within the past year) or active suicidal ideation/behavior or laboratory
  • •abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
  • •Prior/Concomitant Therapy:
  • •9. Previous treatment with an anti-BCMA bispecific antibody.
  • •Prior/Concurrent Clinical Study Experience:
  • •10. Previous administration with an investigational drug within 30 days (or as determined by the local requirement) or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer).
  • •Other Exclusions:
  • •11. Investigator site staff or Pfizer employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members.
  • •12. Known or suspected hypersensitivity to the study drug or any of its excipients.

Investigators

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