Trial Outcomes & Findings for A Study of Elranatamab (PF-06863135) in Chinese Participants With Refractory Multiple Myeloma. (NCT NCT05228470)

Last Updated: 2026-01-06

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

39 participants

Primary outcome timeframe

Cycle 1 (28 days)

Results posted on

2026-01-06

Participant Flow

Chinese participants with relapsed/refractory multiple myeloma (RRMM), who were refractory to at least 1 proteasome inhibitor (PI), 1 immunomodulatory drug (IMiD), and 1 anti-cluster of differentiation38 monoclonal antibody (anti-CD38 mAB) were included.

A total of 38 participants were enrolled and assigned to study treatment. Data for only those primary and secondary outcome measures whose analysis is complete and final have been reported. Data for remaining secondary outcome measures will be posted upon completion of analysis at study completion date.

Participant milestones

Participant milestones
Measure	Phase 1b Participants received subcutaneous (SC) elranatamab with a priming regimen of 12 milligrams (mg) on Cycle 1 Day 1 (C1D1) and 32 mg on Cycle 1 Day 4 (C1D4) followed by 76 mg weekly (QW) thereafter starting from Cycle 1 Day 8. Each cycle was 28 days. If a participant had received QW dosing for at least 6 cycles and had achieved a partial response (PR) or better persisting for at least 2 months, the dose interval was changed to once every 2 weeks (Q2W).	Phase 2 Participants received SC elranatamab with a priming regimen of 12 mg on C1D1 and 32 mg on C1D4 followed by 76 mg QW thereafter starting from Cycle 1 Day 8. Each cycle was 28 days. If a participant had received QW dosing for at least 6 cycles and had achieved a PR or better persisting for at least 2 months, the dose interval was changed to Q2W.
Overall Study STARTED	8	30
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	8	30

Reasons for withdrawal

Reasons for withdrawal
Measure	Phase 1b Participants received subcutaneous (SC) elranatamab with a priming regimen of 12 milligrams (mg) on Cycle 1 Day 1 (C1D1) and 32 mg on Cycle 1 Day 4 (C1D4) followed by 76 mg weekly (QW) thereafter starting from Cycle 1 Day 8. Each cycle was 28 days. If a participant had received QW dosing for at least 6 cycles and had achieved a partial response (PR) or better persisting for at least 2 months, the dose interval was changed to once every 2 weeks (Q2W).	Phase 2 Participants received SC elranatamab with a priming regimen of 12 mg on C1D1 and 32 mg on C1D4 followed by 76 mg QW thereafter starting from Cycle 1 Day 8. Each cycle was 28 days. If a participant had received QW dosing for at least 6 cycles and had achieved a PR or better persisting for at least 2 months, the dose interval was changed to Q2W.
Overall Study Death	6	11
Overall Study Withdrawal by Subject	1	8
Overall Study Ongoing	1	11

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Phase 1b n=8 Participants Participants received SC elranatamab with a priming regimen of 12 mg on C1D1 and 32 mg on C1D4 followed by 76 mg QW thereafter starting from Cycle 1 Day 8.	Phase 2 n=30 Participants Participants received SC elranatamab with a priming regimen of 12 mg on C1D1 and 32 mg on C1D4 followed by 76 mg QW thereafter starting from Cycle 1 Day 8.	Total n=38 Participants Total of all reporting groups
Age, Continuous	54.8 Years STANDARD_DEVIATION 12.19 • n=37 Participants	62.3 Years STANDARD_DEVIATION 7.53 • n=56 Participants	60.7 Years STANDARD_DEVIATION 9.07 • n=82 Participants
Sex: Female, Male Female	4 Participants n=37 Participants	12 Participants n=56 Participants	16 Participants n=82 Participants
Sex: Female, Male Male	4 Participants n=37 Participants	18 Participants n=56 Participants	22 Participants n=82 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=37 Participants	0 Participants n=56 Participants	0 Participants n=82 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	8 Participants n=37 Participants	30 Participants n=56 Participants	38 Participants n=82 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=37 Participants	0 Participants n=56 Participants	0 Participants n=82 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=37 Participants	0 Participants n=56 Participants	0 Participants n=82 Participants
Race (NIH/OMB) Asian	8 Participants n=37 Participants	30 Participants n=56 Participants	38 Participants n=82 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=37 Participants	0 Participants n=56 Participants	0 Participants n=82 Participants
Race (NIH/OMB) Black or African American	0 Participants n=37 Participants	0 Participants n=56 Participants	0 Participants n=82 Participants
Race (NIH/OMB) White	0 Participants n=37 Participants	0 Participants n=56 Participants	0 Participants n=82 Participants
Race (NIH/OMB) More than one race	0 Participants n=37 Participants	0 Participants n=56 Participants	0 Participants n=82 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=37 Participants	0 Participants n=56 Participants	0 Participants n=82 Participants

PRIMARY outcome

Timeframe: Cycle 1 (28 days)

Population: DLT evaluable analysis set included all participants enrolled to Phase 1b part and who had a DLT in the DLT observation period or completed the DLT observation period without DLT. Participants without DLTs and without the minimum required exposure for reasons other than treatment-related toxicity were not evaluable for DLTs and were replaced.

Outcome measures

Outcome measures
Measure	Phase 1b n=6 Participants Participants received SC elranatamab with a priming regimen of 12 mg on C1D1 and 32 mg on C1D4 followed by 76 mg QW thereafter starting from Cycle 1 Day 8.	Phase 2 Participants received SC elranatamab with a priming regimen of 12 mg on C1D1 and 32 mg on C1D4 followed by 76 mg QW thereafter starting from Cycle 1 Day 8.	Phase 1b + Phase 2 Participants received SC elranatamab with a priming regimen of 12 mg on C1D1 and 32 mg on C1D4 followed by 76 mg QW thereafter starting from Cycle 1 Day 8.
Phase 1b: Number of Participants With Dose-Limiting Toxicities (DLT)	1 Participants	—	—

PRIMARY outcome

Timeframe: From date of first dose until confirmed disease progression, death, start of new anticancer therapy, whichever occurred first (approximately up to 16 months)

Population: The primary analysis of ORR as planned per protocol included participants who started with the recommended phase 2 dose \[RP2D\] (including the participants from both Phase 1b and Phase 2 parts). Safety analysis set included all enrolled participants who received at least 1 dose of study intervention.

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.

Outcome measures

Outcome measures
Measure	Phase 1b n=8 Participants Participants received SC elranatamab with a priming regimen of 12 mg on C1D1 and 32 mg on C1D4 followed by 76 mg QW thereafter starting from Cycle 1 Day 8.	Phase 2 n=30 Participants Participants received SC elranatamab with a priming regimen of 12 mg on C1D1 and 32 mg on C1D4 followed by 76 mg QW thereafter starting from Cycle 1 Day 8.	Phase 1b + Phase 2 n=38 Participants Participants received SC elranatamab with a priming regimen of 12 mg on C1D1 and 32 mg on C1D4 followed by 76 mg QW thereafter starting from Cycle 1 Day 8.
Objective Response Rate (ORR) by Blinded Independent Central Review (BICR) as Per International Myeloma Working Group (IMWG) Criteria	37.5 Percentage of participants Interval 8.5 to 75.5	53.3 Percentage of participants Interval 34.3 to 71.7	50.0 Percentage of participants Interval 33.4 to 66.6

SECONDARY outcome

Timeframe: 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)

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From date of first dose until confirmed disease progression, death, start of new anticancer therapy, whichever occurred first (up to approximately 37 months)

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From date of first dose until confirmed disease progression, death, start of new anticancer therapy, whichever occurred first (up to approximately 37 months)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From date of first dose until confirmed disease progression, death, start of new anticancer therapy, whichever occurred first (up to approximately 37 months)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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)

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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)

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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)

OS was defined as time from date of first dose until death due to any cause.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From date of first dose until confirmed disease progression, death, start of new anticancer therapy, whichever occurs first (approximately up to 16 months)

Population: Safety analysis set included all enrolled participants who received at least 1 dose of study intervention. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure

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.

Outcome measures

Outcome measures
Measure	Phase 1b n=3 Participants Participants received SC elranatamab with a priming regimen of 12 mg on C1D1 and 32 mg on C1D4 followed by 76 mg QW thereafter starting from Cycle 1 Day 8.	Phase 2 n=16 Participants Participants received SC elranatamab with a priming regimen of 12 mg on C1D1 and 32 mg on C1D4 followed by 76 mg QW thereafter starting from Cycle 1 Day 8.	Phase 1b + Phase 2 n=19 Participants Participants received SC elranatamab with a priming regimen of 12 mg on C1D1 and 32 mg on C1D4 followed by 76 mg QW thereafter starting from Cycle 1 Day 8.
Time-to-Response (TTR) as Per IMWG Criteria by BICR	2.04 Months Interval 1.15 to 4.73	1.45 Months Interval 0.95 to 5.52	1.51 Months Interval 0.95 to 5.52

SECONDARY outcome

Timeframe: From date of first dose until confirmed disease progression, death, start of new anticancer therapy, whichever occurs first (up to approximately 37 months)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From date of first dose until confirmed disease progression, death, start of new anticancer therapy, whichever occurred first (up to approximately 37 months)

MRD negativity rate was the percentage of participants with CR/sCR and with negative MRD per IMWG sequencing criteria.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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)

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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)

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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)

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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)

Population: Pharmacokinetic (PK) parameter analysis set included all participants enrolled and treated who had at least 1 of the PK parameters of primary interest in the single dose and/or multiple-dose PK part. Here, "Number of Participants Analyzed" signifies participants evaluable for this outcome measure.

Outcome measures

Outcome measures
Measure	Phase 1b n=7 Participants Participants received SC elranatamab with a priming regimen of 12 mg on C1D1 and 32 mg on C1D4 followed by 76 mg QW thereafter starting from Cycle 1 Day 8.	Phase 2 n=6 Participants Participants received SC elranatamab with a priming regimen of 12 mg on C1D1 and 32 mg on C1D4 followed by 76 mg QW thereafter starting from Cycle 1 Day 8.	Phase 1b + Phase 2 n=13 Participants Participants received SC elranatamab with a priming regimen of 12 mg on C1D1 and 32 mg on C1D4 followed by 76 mg QW thereafter starting from Cycle 1 Day 8.
Maximum Serum Concentration (Cmax) of Free Elranatamab	0.8762 Microgram per milliliter Geometric Coefficient of Variation 66	0.8039 Microgram per milliliter Geometric Coefficient of Variation 24	0.8420 Microgram per milliliter Geometric Coefficient of Variation 48

SECONDARY outcome

Population: PK parameter analysis set included all participants enrolled and treated who had at least 1 of the PK parameters of primary interest in the single dose and/or multiple-dose PK part. Here, "Number of Participants Analyzed" signifies participants evaluable for this outcome measure.

Outcome measures

Outcome measures
Measure	Phase 1b n=7 Participants Participants received SC elranatamab with a priming regimen of 12 mg on C1D1 and 32 mg on C1D4 followed by 76 mg QW thereafter starting from Cycle 1 Day 8.	Phase 2 n=6 Participants Participants received SC elranatamab with a priming regimen of 12 mg on C1D1 and 32 mg on C1D4 followed by 76 mg QW thereafter starting from Cycle 1 Day 8.	Phase 1b + Phase 2 n=13 Participants Participants received SC elranatamab with a priming regimen of 12 mg on C1D1 and 32 mg on C1D4 followed by 76 mg QW thereafter starting from Cycle 1 Day 8.
Time To Maximum Serum Concentration (Tmax) of Free Elranatamab	7.00 Days Interval 3.93 to 9.97	8.00 Days Interval 6.94 to 11.0	7.00 Days Interval 3.93 to 11.0

SECONDARY outcome

Outcome measures

Outcome measures
Measure	Phase 1b n=7 Participants Participants received SC elranatamab with a priming regimen of 12 mg on C1D1 and 32 mg on C1D4 followed by 76 mg QW thereafter starting from Cycle 1 Day 8.	Phase 2 n=6 Participants Participants received SC elranatamab with a priming regimen of 12 mg on C1D1 and 32 mg on C1D4 followed by 76 mg QW thereafter starting from Cycle 1 Day 8.	Phase 1b + Phase 2 n=13 Participants Participants received SC elranatamab with a priming regimen of 12 mg on C1D1 and 32 mg on C1D4 followed by 76 mg QW thereafter starting from Cycle 1 Day 8.
Area Under the Concentration-Time Curve From Time Zero to Time of Last Measurable Concentration (AUClast) of Free Elranatamab	3.482 Microgram*day per milliliter Geometric Coefficient of Variation 74	3.864 Microgram*day per milliliter Geometric Coefficient of Variation 37	3.653 Microgram*day per milliliter Geometric Coefficient of Variation 56

SECONDARY outcome

Timeframe: Up to 37 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From the date of first dose up to 37 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and up to 37 months

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and up to 37 months

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).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and up to 37 months

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and up to 37 months

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).

Outcome measures

Outcome data not reported

Adverse Events

Phase 1b

Serious events: 6 serious events

Other events: 8 other events

Deaths: 6 deaths

Phase 2

Serious events: 23 serious events

Other events: 30 other events

Deaths: 13 deaths

Phase 1b + Phase 2

Serious events: 29 serious events

Other events: 38 other events

Deaths: 19 deaths

Serious adverse events

Other adverse events

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer Inc.

Phone: 1-800-718-1021

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Publication restrictions are in place

Restriction type: OTHER