Phase 2
N=38
A Study of Elranatamab (PF-06863135) in Chinese Participants With Refractory Multiple Myeloma.
Elranatamab · Myeloma · Multiple Myeloma · Relapsed Multiple Myeloma · Refractory Multiple Myeloma
Bottom Line
View on ClinicalTrials.gov: NCT05228470 ↗Enrolled (actual)
38
Serious AEs
76.3%
Results posted
Sep 2024
Primary outcome: Primary: Phase 1b: Number of Participants With Dose-Limiting Toxicities (DLT) — 1 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Elranatamab (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Aug 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Phase 1b: Number of Participants With Dose-Limiting Toxicities (DLT) |
1 | — |
| PRIMARY Objective Response Rate (ORR) by Blinded Independent Central Review (BICR) as Per International Myeloma Working Group (IMWG) Criteria |
37.5; 53.3; 50.0 | 0.0076 sig |
| SECONDARY Duration of Response (DOR) as Per IMWG Criteria by BICR |
— | — |
| SECONDARY Duration of Response (DOR) as Per IMWG Criteria by Investigator Assessment |
— | — |
| SECONDARY Complete Response Rate (CRR) as Per IMWG Criteria by BICR |
— | — |
| SECONDARY Complete Response Rate (CRR) as Per IMWG Criteria by Investigator Assessment |
— | — |
| SECONDARY Objective Response Rate (ORR) as Per IMWG Criteria by Investigator Assessment |
— | — |
| SECONDARY Duration of Complete Response (DOCR) as Per IMWG Criteria by BICR |
— | — |
| SECONDARY Duration of Complete Response (DOCR) as Per IMWG Criteria by Investigator Assessment |
— | — |
| SECONDARY Progression Free Survival (PFS) as Per IMWG Criteria by BICR |
— | — |
| SECONDARY Progression Free Survival (PFS) as Per IMWG Criteria by Investigator Assessment |
— | — |
| SECONDARY Overall Survival (OS) |
— | — |
| SECONDARY Time-to-Response (TTR) as Per IMWG Criteria by BICR |
2.04; 1.45; 1.51 | — |
| SECONDARY Time-to-Response (TTR) as Per IMWG Criteria by Investigator Assessment |
— | — |
| SECONDARY Minimal Residual Disease (MRD) Negativity Rate Per IMWG Sequencing Criteria |
— | — |
| SECONDARY 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 |
— | — |
| SECONDARY Number of Participants With Cytokine Release Syndrome (CRS) Graded According to American Society for Transplantation and Cellular Therapy (ASTCT) Criteria |
— | — |
| SECONDARY Number of Participants With Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) Graded According to ASTCT Criteria |
— | — |
| SECONDARY Maximum Serum Concentration (Cmax) of Free Elranatamab |
0.8762; 0.8039; 0.8420 | — |
| SECONDARY Time To Maximum Serum Concentration (Tmax) of Free Elranatamab |
7.00; 8.00; 7.00 | — |
| SECONDARY Area Under the Concentration-Time Curve From Time Zero to Time of Last Measurable Concentration (AUClast) of Free Elranatamab |
3.482; 3.864; 3.653 | — |
| SECONDARY Serum Concentration of Free Elranatamab |
— | — |
| SECONDARY Percentage of Participants With Positive Anti-Drug Antibody (ADA) and Neutralizing Antibodies (NAb) Against Elranatamab |
— | — |
| SECONDARY Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life of Cancer Participants Core Module (EORTC QLQ-C30) |
— | — |
| SECONDARY Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Myeloma-Specific Module (EORTC QLQ-MY20) |
— | — |
| SECONDARY Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire- Chemotherapy-Induced Peripheral Neuropathy (EORTC QLQ CIPN20) |
— | — |
| SECONDARY Change From Baseline in EuroQol Five Dimensions Questionnaire (EQ-5D) Index Score and in EQ-5D Visual Analogue Score (VAS) (EQ-VAS) |
— | — |
Summary
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.
Eligibility Criteria
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:
- Absolute neutrophil count ≥1.0 × 10^9/L
- Platelets ≥ 25 × 10^9/L
- 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)
Data sourced from ClinicalTrials.gov (NCT05228470). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.