A Study of Elranatamab (PF-06863135) in Chinese Participants With Refractory Multiple Myeloma.

A PHASE 1B/2, OPEN-LABEL STUDY TO EVALUATE THE SAFETY, PHARMACOKINETICS, PHARMACODYNAMICS, AND EFFICACY OF ELRANATAMAB (PF-06863135) IN CHINESE PARTICIPANTS WITH MULTIPLE MYELOMA WHO ARE REFRACTORY TO AT LEAST ONE PROTEASOME INHIBITOR, ONE IMMUNOMODULATORY DRUG AND ONE ANTI-CD38 ANTIBODY (TRIPLE-CLASS REFRACTORY MM)

The purpose of this study is to understand the study medicine (called Elranatamab, or PF-06863135) as potential treatment for refractory multiple myeloma. Multiple myeloma is a form of cancer in the bone that forces healthy blood cells to go out. Sometimes, multiple myeloma does not respond to current therapy or quickly progresses, and this is called refractory multiple myeloma.

Elranatamab is a study medicine that target multiple myeloma and activates the human body to fight against this disease. We are seeking Chinese participants to take part in this study. The study will be 2 parts, called part 1b and part 2. In part 1b, participants will receive Elranatamab at 2 steps priming and full dose as a sc (subcutaneous injection) therapy. We will monitor participants' safety and reactions to the study medicine. This will help us understand the dosage of Elranatamab to be used safely.

In part 2 of the study, participants will receive Elranatamab and their multiple myeloma growth will be monitored. This will help us understand if Elranatamab, when used alone, may be a therapy for refractory multiple myeloma. Participants in this part of the study are expected to take part for about 2 years.

Study Overview

• Status: Completed
• Conditions: Multiple Myeloma; Refractory Multiple Myeloma; Myeloma; Relapsed Multiple Myeloma; Elranatamab; PF-06863135; BCMA; Bispecific; Bispecific Antibody; BCMA-CD3 Bispecific; MagnetisMM-8
• Intervention / Treatment: Drug: Elranatamab

• Study Type: Interventional
• Enrollment (Actual): 39
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100730
    • Peking Union Medical College Hospital
  • Beijing, China, 100191
    • Peking University Third Hospital
  • Beijing, China, 100070
    • Beijing Gaobo Boren Hospital
  • Tianjin, China, 300020
    • Hematology Hospital, Chinese Academy of Medical Sciences
  • Fujian
    • Fuzhou, Fujian, China, 350001
      • Fujian Medical University Union Hospital
  • Guangdong
    • Guangzhou, Guangdong, China, 510080
      • Guangdong Provincial People's Hospital
    • Guangzhou, Guangdong, China, 510515
      • Nanfang Hospital of Southern Medical University
    • Guangzhou, Guangdong, China, 510555
      • Sun Yat-sen University Cancer Center
    • Shenzhen, Guangdong, China, 518035
      • Shenzhen Second People's Hosptial
  • Heilongjiang
    • Harbin, Heilongjiang, China, 150081
      • Harbin medical university cancer hospital
    • Harbin, Heilongjiang, China, 150010
      • Harbin First Hospital
  • Jiangsu
    • Nanjing, Jiangsu, China, 210008
      • Nanjing Drum Tower Hospital,the Affiliated Hospital of Nanjing University Medical School
  • Jilin
    • Changchun, Jilin, China, 130021
      • The First Hospital of Jilin University
  • Shandong
    • Jinan, Shandong, China, 250021
      • Shandong Provincial Hospital
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310003
      • The First Affiliated Hospital of College of Medicine, Zhejiang University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Diagnosis of multiple myeloma (IMWG criteria, Rajkumar et al, 2014)
• Measurable disease, as defined by at least 1 of the following:
• Serum M-protein ≥0.5 g/dL
• Urinary M-protein excretion ≥200 mg/24 hours
• 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

• Adequate BM function characterized by the following:

  1. Absolute neutrophil count ≥1.0 × 10^9/L
  2. Platelets ≥ 25 × 10^9/L
  3. Hemoglobin ≥8 g/dL
• 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
• Active Plasma cell leukemia
• Amyloidosis
• POEMS syndrome
• Stem cell transplant or active GVHD within 12 weeks prior to enrollment.
• Previous treatment with an anti-BCMA directed therapy
• Impaired cardiovascular function or clinically significant cardiovascular diseases
• Ongoing Grade ≥2 peripheral sensory or motor neuropathy. History of GBS or GBS variants, or history of any Grade ≥3 peripheral motor polyneuropathy.
• Active HBV, HCV, SARS-CoV2, 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Elranatamab; BCMA-CD3 bispecific antibody	Drug: Elranatamab; BCMA-CD3 bispecific antibody; Other Names: PF-06863135

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Phase 1b: Number of Participants With Dose-Limiting Toxicities (DLT)	Grade(G)4 neutropenia >5 day; febrile neutropenia (absolute neutrophil count [ANC] <1000/millimeter cube (mm^3) with single temperature >38.3 degree Celsius (deg C) or sustained temp>=38 deg C for >1 hour(H); G>=3 neutropenia with infection; G4 thrombocytopenia (unless baseline count >=25,000/mm^3 and <50,000/mm^3, in which case G4 thrombocytopenia to be accompanied by >=G2 bleeding); Platelet count <10,000/mm^3; G3 thrombocytopenia with >=G2 bleeding; G>=4 AE; G3 cytokine release syndrome(CRS) except CRS not maximally treated/improved to <=G1 within 48H; G3 AE except AE attributed to CRS, G3 nausea,vomiting,diarrhea improved to G<=2 within 72H after medical management, G3 fatigue <1 week, G3 AE recovered to baseline/G1 within 5 day; confirmed drug-induced liver injury; G3-4 laboratory (lab) abnormality except G3-4 lab abnormality improved to G<=2 within 72H after medical management & without sequelae;G3 injection site reaction; G2/other clinically important AE may be considered DLT.	Cycle 1 (28 days)
Objective Response Rate (ORR) by Blinded Independent Central Review (BICR) as Per International Myeloma Working Group (IMWG) Criteria	ORR: Percentage of participants with best overall response of confirmed stringent complete response (sCR), CR, very good partial response (VGPR) or PR per IMWG criteria. sCR: CR & normal serum free light chain (sFLC) ratio & absence of clonal cells in BMB/BMA by IH, IF, or flow cytometry. CR: negative immunofixation on serum & urine, disappearance of any soft tissue plasmacytoma & <5% plasma cells in BMA, if disease measurable by sFLC only, preceding criteria plus normal sFLC ratio. VGPR: Serum & urine M-protein detectable by immunofixation but not on electrophoresis; or >=90% reduction in serum M-protein & urine M-protein level <100mg/24h. PR: >=50% reduction in serum M-protein & reduction in 24h urinary M-protein by >=90% or <200 mg/24h. If serum & urine M-protein were unmeasurable, VGPR & PR: >=90% & >=50% decrease in difference respectively between involved & uninvolved sFLC levels & if present at baseline, >=90% & >=50% reduction in soft tissue plasmacytomas' size.	From date of first dose until confirmed disease progression, death, start of new anticancer therapy, whichever occurred first (approximately up to 16 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of Response (DOR) as Per IMWG Criteria by BICR	DOR: Time from first documentation of objective response subsequently confirmed, until first documentation of confirmed PD or death due to any cause, whichever occurred first. PD= increase of >=25% from lowest value in >=1 of following (serum M-protein [absolute increase >=0.5g/dL]; serum M-protein increase >=1g/dL [when lowest M-protein >=5g/dL]; urine M-protein [absolute increase >=200mg/24h]; participants without measurable serum & urine M-protein levels, difference between involved & uninvolved sFLC levels [absolute increase >10mg/dL]; in participants without measurable serum, urine M-protein levels & involved sFLC levels: bone marrow plasma-cell % irrespective of baseline status [absolute increase >=10%]; appearance of new lesion,>=50% increase from nadir in SPD of >1 lesion, or >=50% increase in longest diameter of previous lesion >1cm in short axis; >=50% increase in circulating plasma cells [>=200cells/μL] if this is the only measure of disease.	From first documentation of objective response subsequently confirmed until confirmed PD or death due to any cause, or start of new anticancer therapy, whichever occurred first, or censoring (up to approximately 37 months)
Duration of Response (DOR) as Per IMWG Criteria by Investigator Assessment	DOR: Time from first documentation of objective response subsequently confirmed, until first documentation of confirmed PD or death due to any cause, whichever occurred first. PD= increase of >=25% from lowest value in >=1 of following (serum M-protein [absolute increase >=0.5g/dL]; serum M-protein increase >=1g/dL [when lowest M-protein >=5g/dL]; urine M-protein [absolute increase >=200mg/24h]; participants without measurable serum & urine M-protein levels, difference between involved & uninvolved sFLC levels [absolute increase >10mg/dL]; in participants without measurable serum, urine M-protein levels & involved sFLC levels: bone marrow plasma-cell % irrespective of baseline status [absolute increase >=10%]; appearance of new lesion,>=50% increase from nadir in SPD of >1 lesion, or >=50% increase in longest diameter of previous lesion >1cm in short axis; >=50% increase in circulating plasma cells [>=200cells/μL] if this is the only measure of disease.	From first documentation of objective response subsequently confirmed until confirmed PD or death due to any cause, or start of new anticancer therapy, whichever occurred first, or censoring (up to approximately 37 months)
Complete Response Rate (CRR) as Per IMWG Criteria by BICR	CRR: Percentage of participants with BOR of confirmed sCR/CR per IMWG criteria. sCR: CR & normal serum free light chain (sFLC) ratio & absence of clonal cells in BMB/BMA by IH, IF, or flow cytometry. CR: negative immunofixation on serum & urine, disappearance of any soft tissue plasmacytoma & <5% plasma cells in BMA, if disease measurable by sFLC only, preceding criteria plus normal sFLC ratio.	From date of first dose until confirmed disease progression, death, start of new anticancer therapy, whichever occurred first (up to approximately 37 months)
Complete Response Rate (CRR) as Per IMWG Criteria by Investigator Assessment	CRR: Percentage of participants with BOR of confirmed sCR/CR per IMWG criteria. sCR: CR & normal serum free light chain (sFLC) ratio & absence of clonal cells in BMB/BMA by IH, IF, or flow cytometry. CR: negative immunofixation on serum & urine, disappearance of any soft tissue plasmacytoma & <5% plasma cells in BMA, if disease measurable by sFLC only, preceding criteria plus normal sFLC ratio.	From date of first dose until confirmed disease progression, death, start of new anticancer therapy, whichever occurred first (up to approximately 37 months)
Objective Response Rate (ORR) as Per IMWG Criteria by Investigator Assessment	ORR: Percentage of participants with best overall response of confirmed stringent complete response (sCR), CR, very good partial response (VGPR) or PR per IMWG criteria. sCR: CR & normal serum free light chain (sFLC) ratio & absence of clonal cells in BMB/BMA by IH, IF, or flow cytometry. CR: negative immunofixation on serum & urine, disappearance of any soft tissue plasmacytoma & <5% plasma cells in BMA, if disease measurable by sFLC only, preceding criteria plus normal sFLC ratio. VGPR: Serum & urine M-protein detectable by immunofixation but not on electrophoresis; or >=90% reduction in serum M-protein & urine M-protein level <100mg/24h. PR: >=50% reduction in serum M-protein & reduction in 24h urinary M-protein by >=90% or <200 mg/24h. If serum & urine M-protein were unmeasurable, VGPR & PR: >=90% & >=50% decrease in difference respectively between involved & uninvolved sFLC levels & if present at baseline, >=90% & >=50% reduction in soft tissue plasmacytomas' size.	From date of first dose until confirmed disease progression, death, start of new anticancer therapy, whichever occurred first (up to approximately 37 months)
Duration of Complete Response (DOCR) as Per IMWG Criteria by BICR	DOCR: Time from first documentation of sCR/CR subsequently confirmed, until first documentation of confirmed PD or death due to any cause, whichever occurred first. PD= increase of >=25% from lowest value in >=1 of following (serum M-protein [absolute increase >=0.5g/dL]; serum M-protein increase >=1g/dL [when lowest M-protein >=5g/dL]; urine M-protein [absolute increase >=200mg/24h]; participants without measurable serum & urine M-protein levels, difference between involved & uninvolved sFLC levels [absolute increase >10mg/dL]; in participants without measurable serum, urine M-protein levels & involved sFLC levels: bone marrow plasma-cell % irrespective of baseline status [absolute increase >=10%]; appearance of new lesion,>=50% increase from nadir in SPD of >1 lesion, or >=50% increase in longest diameter of previous lesion >1cm in short axis; >=50% increase in circulating plasma cells [>=200cells/μL] if this is the only measure of disease.	From first documentation of sCR/CR subsequently confirmed until confirmed PD or death due to any cause, or start of new anticancer therapy, whichever occurred first, or censoring (up to approximately 37 months)
Duration of Complete Response (DOCR) as Per IMWG Criteria by Investigator Assessment	DOCR: Time from first documentation of sCR/CR subsequently confirmed, until first documentation of confirmed PD or death due to any cause, whichever occurred first. PD= increase of >=25% from lowest value in >=1 of following (serum M-protein [absolute increase >=0.5g/dL]; serum M-protein increase >=1g/dL [when lowest M-protein >=5g/dL]; urine M-protein [absolute increase >=200mg/24h]; participants without measurable serum & urine M-protein levels, difference between involved & uninvolved sFLC levels [absolute increase >10mg/dL]; in participants without measurable serum, urine M-protein levels & involved sFLC levels: bone marrow plasma-cell % irrespective of baseline status [absolute increase >=10%]; appearance of new lesion,>=50% increase from nadir in SPD of >1 lesion, or >=50% increase in longest diameter of previous lesion >1cm in short axis; >=50% increase in circulating plasma cells [>=200cells/μL] if this is the only measure of disease.	From the first documentation of sCR/CR, until confirmed PD per IMWG criteria, or death due to any cause, whichever occurred first (up to approximately 37 months)
Progression Free Survival (PFS) as Per IMWG Criteria by BICR	PFS was defined as the time from the date of first dose until confirmed PD or death due to any cause, whichever occurred first. PD= increase of >=25% from lowest value in >=1 of following (serum M-protein [absolute increase >=0.5g/dL]; serum M-protein increase >=1g/dL [when lowest M-protein >=5g/dL]; urine M-protein [absolute increase >=200mg/24h]; participants without measurable serum & urine M-protein levels, difference between involved & uninvolved sFLC levels [absolute increase >10mg/dL]; in participants without measurable serum, urine M-protein levels & involved sFLC levels: bone marrow plasma-cell % irrespective of baseline status [absolute increase >=10%]; appearance of new lesion,>=50% increase from nadir in SPD of >1 lesion, or >=50% increase in longest diameter of previous lesion >1cm in short axis; >=50% increase in circulating plasma cells [>=200cells/μL] if this is the only measure of disease.	From date of first dose until confirmed PD or death due to any cause, or start of new anticancer therapy, whichever occurred first, or censoring (up to approximately 37 months)
Progression Free Survival (PFS) as Per IMWG Criteria by Investigator Assessment	PFS was defined as the time from the date of first dose until confirmed PD or death due to any cause, whichever occurred first. PD= increase of >=25% from lowest value in >=1 of following (serum M-protein [absolute increase >=0.5g/dL]; serum M-protein increase >=1g/dL [when lowest M-protein >=5g/dL]; urine M-protein [absolute increase >=200mg/24h]; participants without measurable serum & urine M-protein levels, difference between involved & uninvolved sFLC levels [absolute increase >10mg/dL]; in participants without measurable serum, urine M-protein levels & involved sFLC levels: bone marrow plasma-cell % irrespective of baseline status [absolute increase >=10%]; appearance of new lesion,>=50% increase from nadir in SPD of >1 lesion, or >=50% increase in longest diameter of previous lesion >1cm in short axis; >=50% increase in circulating plasma cells [>=200cells/μL] if this is the only measure of disease.	From date of first dose until confirmed PD or death due to any cause, or start of new anticancer therapy, whichever occurred first, or censoring (up to approximately 37 months)
Overall Survival (OS)	OS was defined as time from date of first dose until death due to any cause.	From the date of first dose until death due to any cause. Participants not known to have died were censored on the date of last known alive (up to approximately 37 months)
Time-to-Response (TTR) as Per IMWG Criteria by BICR	TTR was defined, for participants with an objective response per IMWG criteria, as the time from the date of first dose to the first documentation of objective response that was subsequently confirmed.	From date of first dose until confirmed disease progression, death, start of new anticancer therapy, whichever occurs first (approximately up to 16 months)
Time-to-Response (TTR) as Per IMWG Criteria by Investigator Assessment	TTR was defined, for participants with an objective response per IMWG criteria, as the time from the date of first dose to the first documentation of objective response that was subsequently confirmed.	From date of first dose until confirmed disease progression, death, start of new anticancer therapy, whichever occurs first (up to approximately 37 months)
Minimal Residual Disease (MRD) Negativity Rate Per IMWG Sequencing Criteria	MRD negativity rate was the percentage of participants with CR/sCR and with negative MRD per IMWG sequencing criteria.	From date of first dose until confirmed disease progression, death, start of new anticancer therapy, whichever occurred first (up to approximately 37 months)
Number of Participants With Treatment Emergent Adverse Events (TEAE), Serious TEAEs, Treatment Related TEAEs, Serious Treatment Related TEAEs as Graded by National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0	AE was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to study intervention. An SAE was defined as any untoward medical occurrence that, at any dose resulted in any of the following outcomes: death; life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect; or that was considered as an important medical event. An AE was considered treatment-emergent if it occurred from the first dose of the study intervention until 90 days after the last dose or the day before starting a new anticancer therapy, whichever occurred first. CTCAE version 5.0 Grade 1: mild; Grade 2: moderate; Grade 3: severe or clinically significant; Grade 4: life-threatening; Grade 5: death.	From the date of first dose up to 90 days after last dose or new anticancer therapy whichever occurred first (up to approximately 37 months)
Number of Participants With Cytokine Release Syndrome (CRS) Graded According to American Society for Transplantation and Cellular Therapy (ASTCT) Criteria	ASTCT CRS Grading: Grade 1: temperature >=38°C without hypotension or hypoxia; Grade 2: temperature >=38°C with hypotension not requiring vasopressors, and/or hypoxia requiring low-flow nasal cannula, facemask or blow-by; Grade 3: temperature >=38°C with hypotension requiring a vasopressor with or without vasopressin and/or hypoxia requiring high-flow nasal cannula, facemask, nonrebreather mask, or Venturi mask; Grade 4: temperature >=38°C with hypotension requiring multiple vasopressors (excluding vasopressin) and/or hypoxia requiring positive pressure (eg, continuous positive airway pressure [CPAP], bilevel positive airway pressure [BiPAP], intubation and mechanical ventilation); Grade 5: death	From the date of first dose up to 90 days after last dose or new anticancer therapy whichever occurred first (up to approximately 37 months)
Number of Participants With Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) Graded According to ASTCT Criteria	ICANS Grade 1: immune effector cell encephalopathy (ICE) score 7-9, participant awakens spontaneously; Grade 2: ICE score 3-6, participant awakens to voice; Grade 3: ICE score 0-2, participant awakens only to tactile stimulus, any clinical seizure focal or generalized that resolved rapidly or nonconvulsive seizures on electroencephalography that resolve with intervention or focal/local edema on neuroimaging; Grade 4: ICE score 0 (participant is unarousable and unable to perform ICE), participant unarousable or requires vigorous or repetitive tactile stimuli to arouse, life-threatening prolonged seizure (>5 min), repetitive clinical or electrical seizures without return to baseline in between, deep focal motor weakness, diffuse cerebral edema on neuroimaging; decerebrate/decorticate posturing; cranial nerve VI palsy; papilledema, Cushing's triad; Grade 5: death. ICE: measures alterations in speech, orientation, handwriting, attention and receptive aphasia.	From the date of first dose up to 90 days after last dose or new anticancer therapy whichever occurred first (up to approximately 37 months)
Maximum Serum Concentration (Cmax) of Free Elranatamab		Cycle 1: Pre-dose, 6 hours post-dose on Day 1, 24, 48 hours post-dose, Day 4: pre-dose, 24 hour post-dose, Day 8 pre-dose, 6 hours post-dose, Day 15,22: pre-dose, Cycles 2, 3 ,4,7: pre-dose (1 cycle =28 days)
Time To Maximum Serum Concentration (Tmax) of Free Elranatamab		Cycle 1: Pre-dose, 6 hours post-dose on Day 1, 24, 48 hours post-dose, Day 4: pre-dose, 24 hour post-dose, Day 8 pre-dose, 6 hours post-dose, Day 15,22: pre-dose, Cycles 2, 3 ,4,7: pre-dose (1 cycle =28 days)
Area Under the Concentration-Time Curve From Time Zero to Time of Last Measurable Concentration (AUClast) of Free Elranatamab		Cycle 1: Pre-dose, 6 hours post-dose on Day 1, 24, 48 hours post-dose, Day 4: pre-dose, 24 hour post-dose, Day 8 pre-dose, 6 hours post-dose, Day 15,22: pre-dose, Cycles 2, 3 ,4,7: pre-dose (1 cycle =28 days)
Serum Concentration of Free Elranatamab		Up to 37 months
Percentage of Participants With Positive Anti-Drug Antibody (ADA) and Neutralizing Antibodies (NAb) Against Elranatamab		From the date of first dose up to 37 months
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life of Cancer Participants Core Module (EORTC QLQ-C30)	EORTC QLQ-C30 contains 30 items and is composed of both multi-item scales and single-item measures. These include 5 functional scales (physical, role, emotional, cognitive and social functioning), 3 symptom scales (fatigue, nausea/vomiting, and pain), 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea and financial impact) and a global health status/QoL scale. All the scales and single-item measures range in score from 0 to 100. Higher scores on the functional scales represent higher levels of functioning. Higher scores on the global health status/quality of life scale represent higher health status/quality of life. Higher scores on symptom scales/items represent a greater presence of symptoms.	Baseline and up to 37 months
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Myeloma-Specific Module (EORTC QLQ-MY20)	EORTC MY20 is a myeloma-specific module developed by the EORTC group specifically to assess quality of life in participants with multiple myeloma. It contains 20 items which can be grouped into a disease symptom subscale (6 items), side effects of treatment subscale (10 items), body image (1 item) and future perspective subscale (3 items). All transformed scale scores range from 0 to 100 with higher scores indicating worse symptoms (Disease Symptoms and Side Effects of Treatment) or better support/functioning (Future Perspective and Body Image).	Baseline and up to 37 months
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire- Chemotherapy-Induced Peripheral Neuropathy (EORTC QLQ CIPN20)	EORTC QLQ CIPN20 is a module developed by the EORTC group to assess chemotherapy-induced peripheral neuropathy. It contains 20 items which can be grouped into a sensory subscale (9 items), motor subscale (8 items) and autonomic subscale (3 items). Sensory scale scores range from 1 to 36, motor scale scores range from 1 to 32, and autonomic scale scores range from 1 to 12 for men and 1-8 for women (erect dysfunction item excluded). Higher scores indicate worse neuropathy.	Baseline and up to 37 months
Change From Baseline in EuroQol Five Dimensions Questionnaire (EQ-5D) Index Score and in EQ-5D Visual Analogue Score (VAS) (EQ-VAS)	The EQ-5D is a 6-item questionnaire with 2 components, a Health State Profile which has individuals rate their level of problems in 5 areas (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), and a VAS in which patients rate their overall health status from 0 (worst imaginable) to 100 (best imaginable). Overall scores range from 0 to 1, with lower scores representing higher levels of dysfunction. EQ-VAS records the participant's self-rated health on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state).	Baseline and up to 37 months

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): December 21, 2021
• Primary Completion (Actual): August 6, 2023
• Study Completion (Actual): September 11, 2025

Study Registration Dates

• First Submitted: January 5, 2022
• First Submitted That Met QC Criteria: January 26, 2022
• First Posted (Actual): February 8, 2022

Study Record Updates

• Last Update Posted (Estimated): January 6, 2026
• Last Update Submitted That Met QC Criteria: December 15, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Multiple Myeloma; Immune System Diseases; Vascular Diseases; Cardiovascular Diseases; Neoplasms; Hematologic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Neoplasms by Histologic Type; Neoplasms, Plasma Cell; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders
• Additional Relevant MeSH Terms: Lymphatic Diseases; Hemic and Lymphatic Diseases; Neoplasms; Cardiovascular Diseases; Vascular Diseases; Multiple Myeloma; Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Hematologic Diseases; Lymphoproliferative Disorders; Immune System Diseases; Immunoproliferative Disorders; Hemostatic Disorders; Paraproteinemias; Hemorrhagic Disorders; Blood Protein Disorders
• Other Study ID Numbers: C1071008; NCT05228470 (Registry Identifier: ClinicalTrials.gov)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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/data_requests.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes