Phase 2
N=85
A Study to Learn About the Study Medicine (Elranatamab) in Participants With Multiple Myeloma That Has Come Back After Responding to Treatment or Has Not Responded to Treatment
Multiple Myeloma
Bottom Line
View on ClinicalTrials.gov: NCT05014412 ↗Enrolled (actual)
85
Serious AEs
74.1%
Results posted
Jul 2024
Primary outcome: Primary: Number of Participants With Grade 2 or Higher Cytokine Release Syndrome (CRS) During Cycle 1: Parts 1 and 2 — 12 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
- Jun 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Grade 2 or Higher Cytokine Release Syndrome (CRS) During Cycle 1: Parts 1 and 2 |
12 | — |
| SECONDARY Number of Participants With Dose Limiting Toxicities (DLTs): Part 2A |
1; 1 | — |
| SECONDARY Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs) [All Causalities and Treatment Related]: Parts 1 and 2 |
33; 12; 11; 29; 23; 11 | — |
| SECONDARY Number of Participants With Maximum Grade 3 or 4 and Grade 5 AEs [All Causalities and Treatment Related] Per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5: Parts 1 and 2 |
26; 9; 6; 20; 5; 2 | — |
| SECONDARY Number of Participants With Adverse Events of Special Interest (AESI)- CRS and Immune Effector Cell-associated Neurotoxicity Syndrome (ICANS) [All Causalities and Treatment Related]: Parts 1 and 2 |
20; 10; 10; 14; 1; 1 | — |
| SECONDARY Number of Participants With Hematological Measures With Baseline CTCAE Grade >=2 Shifted to a Maximum CTCAE Grade 3-4: Parts 1 and 2 |
— | — |
| SECONDARY Number of Participants With Clinical Chemistry Parameters With Baseline CTCAE Grade >=2 Shifted to a Maximum CTCAE Grade 3-4: Parts 1 and 2 |
— | — |
| SECONDARY Number of Participants With Liver Function Tests Abnormalities: Parts 1 and 2 |
— | — |
| SECONDARY Objective Response Rate (ORR) Per International Myeloma Working Group (IMWG) Response Criteria as Determined by Investigator: Parts 1 and 2 |
— | — |
| SECONDARY Complete Response Rate (CRR) Per IMWG Response Criteria as Determined by Investigator: Parts 1 and 2 |
— | — |
| SECONDARY Time to Response (TTR) Per IMWG Response Criteria as Determined by Investigator: Parts 1 and 2 |
— | — |
| SECONDARY Duration of Response (DOR) Per IMWG Response Criteria as Determined by Investigator: Parts 1 and 2 |
— | — |
| SECONDARY Duration of Complete Response Rate (DOCR) Per IMWG Response Criteria as Determined by Investigator: Parts 1 and 2 |
— | — |
| SECONDARY Progression Free Survival (PFS) Per IMWG Response Criteria as Determined by Investigator: Parts 1 and 2 |
— | — |
| SECONDARY Overall Survival (OS): Parts 1 and 2 |
— | — |
| SECONDARY Minimal Residual Disease (MRD) Negativity Rate Per IMWG Sequencing Criteria: Parts 1 and 2 |
— | — |
| SECONDARY Pre- and Post-dose Concentrations of Elranatamab: Parts 1 and 2 |
— | — |
| SECONDARY Number of Participants With Anti-Drug Antibody (ADA) and Neutralizing Antibody (Nab) Against Elranatamab: Parts 1 and 2 |
— | — |
Summary
The purpose of the study (Part 1 and Part 2) is to evaluate the safety of a step-up dosing approach (starting with low doses followed by higher doses) of the study medicine (elranatamab) in participants with multiple myeloma that has come back after responding to treatment or has not responded to treatment (relapsed/refractory multiple myeloma). This study will also look at the safety and efficacy of different doses of elranatamab, as well as different intervals between doses.
Participants in the study will receive elranatamab as an injection under the skin at the study clinic. After the initial step-up doses, participants will start receiving one dose every week. The frequency of clinic visits for injections may then decrease over time. Participation will be at least two 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 by SPEP
- Urinary M-protein excretion >200 mg/24 hours by UPEP
- 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 ≤1
- 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
- POEMS syndrome
- Amyloidosis
- Waldenström's macroglobulinemia
- Known active CNS involvement or clinical signs of myelomatous meningeal involvement
- Stem cell transplant within 12 weeks prior to enrollment or active GVHD
- 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 or Stage 0/1 malignancy with minimal risk of recurrence per investigator.
- Previous treatment with an anti-BCMA bispecific antibody or CAR-T cell therapy.
- Live attenuated vaccine within 4 weeks of the first dose
- 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)
- Known or suspected hypersensitivity to the study intervention, or any of its excipients
Data sourced from ClinicalTrials.gov (NCT05014412). 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.