ELRANATAMAB for Relapsed/refractory multiple myeloma

Inclusion criteria

• {"criterion_text":"- Participants aged 18 years or older (or the minimum age of consent in accordance with local regulations if ≥18) at screening."}
• {"criterion_text":"- Prior diagnosis of MM (multiple myeloma) per IMWG criteria and previously received at least 1 but not more than 4 prior lines of therapy for MM including: •\tAt least 2 consecutive cycles of an anti-CD38 antibody-containing regimen in any prior line AND •\tAt least 2 consecutive cycles of a lenalidomide-containing regimen in any prior line"}
• {"criterion_text":"- Documented evidence of progressive disease or failure to achieve a response to last line of MM therapy based on investigator's determination of response by IMWG criteria."}
• {"criterion_text":"- Measurable disease based on IMWG criteria as defined by at least 1 of the following (assessed by central laboratory): •\tSerum M-protein (myeloma protein) ≥0.5 g/dL; •\tUrinary M-protein excretion ≥200 mg/24 hours; •\tSerum involved immunoglobulin FLC (free light chain) ≥10 mg/dL (≥100 mg/L) AND abnormal serum immunoglobulin kappa to lambda FLC ratio (<0.26 or >1.65)."}
• {"criterion_text":"- Corrected serum calcium ≤14 mg/dL (≤3.5 mmol/L), or free ionized calcium ≤6.5 mg/dL (≤1.6 mmol/L)"}
• {"criterion_text":"- Adequate bone marrow function (ANC, platelets, hemoglobin)"}
• {"criterion_text":"- ECOG (Eastern Cooperative Oncology Group) performance status <2."}

Exclusion criteria

• {"criterion_text":"- Plasma cell leukemia, Smoldering MM, Waldenström’s macroglobulinemia, Amyloidosis, POEMS (Polyneuropathy, Organomegaly, Endocrinopathy, Monoclonal gammopathy and Skin abnormalities) Syndrome, known CNS (central nervous system) involvement or clinical signs of myelomatous meningeal involvement, stem cell transplant within 12 weeks prior to enrollment, active GVHD (graft versus host disease) (other than Grade 1 skin involvement) or GVHD requiring treatment."}
• {"criterion_text":"- Unable to receive a control therapy (must be able and willing to adhere to any applicable requirements per Single Reference Safety Document [SRSD] for at least one choice of control therapy, including contraceptive requirements, and must not meet the exclusions listed below for the choice of control therapy): •\tunable to receive PVd if any of the following are present: •\tReceived prior pomalidomide therapy •\tDoes not meet criteria for bortezomib retreatment, (ie, must not have progressive disease during treatment or within 60 days of the last dose of a bortezomib-containing regimen) •\tGrade 1 peripheral neuropathy with pain or Grade ≥2 peripheral neuropathy as defined by NCI-CTCAE v5.0 •\tReceived a strong cytochrome P (CYP) 3A4 inducer within 5 half-lives prior to enrollment •\tActive inflammatory gastrointestinal disease, chronic diarrhea, known diverticular disease or previous gastric resection or lap band surgery (gastroesophageal reflux disease under treatment with proton pump inhibitors is allowed, assuming no drug interaction potential). •\tunable to receive Kd if any of the following are present: •\tReceived prior carfilzomib therapy •\tUncontrolled hypertension •\tunable to receive EPd if any of the following are present: •\tReceived prior pomalidomide therapy •\tReceived prior elotuzumab therapy"}
• {"criterion_text":"- Active inflammatory gastrointestinal disease, chronic diarrhea, known diverticular disease or previous gastric resection or lap band surgery (gastroesophageal reflux disease under treatment with proton pump inhibitors is allowed, assuming no drug interaction potential)."}
• {"criterion_text":"- Live attenuated vaccines within 4 weeks of the first dose of study intervention;"}
• {"criterion_text":"- Cumulative dose of corticosteroids equivalent to ≥140 mg of prednisone (≥21 mg of dexamethasone) within the 14-day period before the first dose of study intervention, and administered for reasons other than anti-myeloma therapy"}
• {"criterion_text":"- Anti-myeloma drug therapy, within 14 days of the initiation of study intervention (includes dexamethasone). Bisphosphonate use permitted."}
• {"criterion_text":"- Impaired hepatic or renal function."}
• {"criterion_text":"- Previous administration with an investigational product (drug or vaccine) 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). Participation in studies of other investigational products (drug or vaccine) at any time during their participation in this study."}
• {"criterion_text":"- Active HBV (Hepatitis B virus), HCV (Hepatitis C virus), SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2), HIV [human immunodeficiency virus], or any active, uncontrolled bacterial, fungal, or viral infection. Active infections must be resolved at least 21 days prior to enrollment. Treatment with systemic anti-infective agents must have completed at least 28 days prior to enrollment. Prophylactic use of systemic anti-infective agents is permitted."}
• {"criterion_text":"- Ongoing Grade ≥3 peripheral sensory or motor neuropathy; history of GBS (Guillain-Barré syndrome) or GBS variants; history of any Grade ≥3 peripheral motor polyneuropathy."}
• {"criterion_text":"- Impaired cardiovascular function or clinically significant cardiovascular diseases within 6 months prior to enrollment, including LVEF (left ventricular ejection fraction) <40% as determined by a MUGA (multigated acquisition) scan or ECHO (echocardiogram) at screening."}
• {"criterion_text":"- 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"}
• {"criterion_text":"- Known or suspected hypersensitivity to the study interventions or any of their excipients."}
• {"criterion_text":"- Unresolved acute effects (excluding alopecia) of any prior therapy (not resolved to baseline severity or CTCAE Grade ≤ 1)."}
• {"criterion_text":"- Previous treatment with a BCMA-directed or CD3 (cluster of differentiation 3) redirecting therapy."}
• {"criterion_text":"- Individuals who have never achieved a response (partial response [PR] or better) with any treatment during the disease course."}

Primary endpoints

• {"endpoint_text":"- PFS (progression free survival) by BICR (blinded independent central review) per IMWG (International Myeloma Working Group)","definition_or_measurement_approach":"Progression-free survival assessed by blinded independent central review (BICR) according to IMWG criteria."}

Secondary endpoints

• {"endpoint_text":"- OS (overall survival)","definition_or_measurement_approach":"Overall survival (OS) measured as time from randomization to death from any cause."}
• {"endpoint_text":"- •\tPFS by Investigator per IMWG •\tPFS2 (PFS on next line therapy) by Investigator per IMWG •\tORR (objective response rate) by BICR per IMWG •\tDOR (duration of response) by BICR per IMWG •\tVGPRR (very good partial response rate) (≥VGPR) (very good partial response) by BICR per IMWG •\tCRR (complete response rate) by BICR per IMWG •\tDOCR (duration of complete response) by BICR per IMWG •\tTTR (time to response) by BICR per IMWG","definition_or_measurement_approach":"Multiple efficacy endpoints assessed per IMWG; PFS by investigator, PFS2 (on next-line therapy) by investigator, objective response and response rates and durations assessed by blinded independent central review (BICR) per IMWG; time-to-response metrics per BICR/IMWG."}
• {"endpoint_text":"- •\tAEs (adverse events) •\tLaboratory abnormalities","definition_or_measurement_approach":"Safety endpoints captured as adverse events (AEs) and laboratory abnormalities using standard reporting (e.g., NCI-CTCAE)."}
• {"endpoint_text":"- •PFS by BICR per IMWG •OS (overall survival) •PFS and PFS2 by Investigator per IMWG •ORR by BICR per IMWG •\tDOR by BICR per IMWG •\tVGPRR by BICR per IMWG •CRR by BICR per IMWG •DOCR by BICR per IMWG •TTR by BICR per IMWG •MRD negativity rate per IMWG •Sustained MRD negativity rate for at least 12 months per IMWG •AEs •Laboratory abnormalities","definition_or_measurement_approach":"Composite list repeating efficacy and safety endpoints including MRD negativity (measured per IMWG), sustained MRD negativity ≥12 months, and other efficacy endpoints measured by BICR or investigator per IMWG; safety via AEs and labs."}
• {"endpoint_text":"- Pre- and post-dose concentrations of elranatamab","definition_or_measurement_approach":"Pharmacokinetic assessments of elranatamab pre- and post-dose concentrations."}
• {"endpoint_text":"- ADA (antidrug antibody) and NAb (neutralizing antibody) against elranatamab","definition_or_measurement_approach":"Immunogenicity assessments: measurement of anti-drug antibodies (ADA) and neutralizing antibodies (NAb) against elranatamab."}
• {"endpoint_text":"- •\tChange from baseline EORTC QLQ-C30 (European Organisation for Research and Treatment of Cancer Quality of Life Cancer Questionnaire 30) scores (global health, fatigue, pain, physical functioning, role functioning, and emotional functioning domains) •\tChange from baseline MY20 (multiple myeloma module quality of life questionnaire) scores (disease symptoms, side-effects of treatment, body image, and future perspective domains)","definition_or_measurement_approach":"Health-related quality of life measured as change from baseline on EORTC QLQ-C30 and MY20 domains."}

Methods

• Program-level brochures (MagnetisMM program brochure) for participant information and outreach (country-specific materials listed).
• Clinic posters displayed at participating sites (country-specific versions).
• Study flyers and postcards with QR codes directing to study video/materials (country-specific versions).
• Understanding Your Study videos (participant-facing study explanation videos).
• Email communications to potential participants (email comm templates listed).
• Informed consent flipbooks and participant-facing screening reports (site-facing screening tools and participant-facing materials).
• Country-specific recruitment materials and translations (multiple country packs and language variants listed in documents).

Spain

Earliest CTIS Part Ii Submission Date

15-04-2024

Latest Decision Or Authorization Date

09-05-2024

Processing Time Days

24

Number Of Sites

12

Number Of Participants

54

Primary sponsor

Full Name

Pfizer Inc.

Organisation Type

Pharmaceutical company

Country Of Registered Address

United States

Contract research organisations

Name

Signant Health Global Solutions Limited

Responsibilities

eCOA

Name

PPD Development LP

Responsibilities

CRO functions (role code 4 in metadata)

Name

Icon Clinical Research Limited

Responsibilities

CRO functions (role code 4 in metadata)

Name

ICON Medical Imaging

Responsibilities

Central reading of images

Name

Icon Laboratory Services Inc.

Responsibilities

Laboratory services (role code 4 in metadata)

Name

Hematogenix Laboratory Services Limited

Responsibilities

Laboratory services (role code 4 in metadata)

Name

WCG Clinical Inc.

Responsibilities

Study coordination support services

Name

Adaptive Biotechnologies Corp.

Responsibilities

Laboratory/MRD services (role code 4 in metadata)

Name

Personalis Inc.

Responsibilities

Laboratory/genomic services (role code 4 in metadata)

Third parties

• {"country":"Ireland","full_name":"Signant Health Global Solutions Limited","duties_or_roles":"eCOA","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"PPD Development LP","duties_or_roles":"code 4 (role code provided in CTIS metadata)","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"ICON Medical Imaging","duties_or_roles":"Central Reading of Images","organisation_type":"Industry"}
• {"country":"United Kingdom","full_name":"Hematogenix Laboratory Services Limited","duties_or_roles":"code 4 (role code provided in CTIS metadata)","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United States","full_name":"Icon Laboratory Services Inc.","duties_or_roles":"code 4 (role code provided in CTIS metadata)","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"code 4 (role code provided in CTIS metadata)","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Personalis Inc.","duties_or_roles":"code 4 (role code provided in CTIS metadata)","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United States","full_name":"WCG Clinical Inc.","duties_or_roles":"Study coordination support services","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Adaptive Biotechnologies Corp.","duties_or_roles":"code 4 (role code provided in CTIS metadata)","organisation_type":"Pharmaceutical company"}