Clinical Trials Register

Summary
EudraCT Number:	2021-006052-14
Sponsor's Protocol Code Number:	C1071007
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2022-02-10
Trial results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Spain - AEMPS

A.2

EudraCT number

2021-006052-14

A.3

Full title of the trial

MAGNETISMM-7
A RANDOMIZED, 2-ARM, PHASE 3 STUDY OF ELRANATAMAB (PF-06863135) VERSUS LENALIDOMIDE IN PATIENTS WITH NEWLY DIAGNOSED MULTIPLE MYELOMA WHO ARE MINIMAL RESIDUAL DISEASE POSITIVE AFTER UNDERGOING AUTOLOGOUS STEM-CELL TRANSPLANTATION

MAGNETISMM-7
ESTUDIO EN FASE III ALEATORIZADO Y DE DOS GRUPOS DE ELRANATAMAB (PF-06863135) FRENTE A LENALIDOMIDA EN PACIENTES CON MIELOMA MÚLTIPLE DE DIAGNÓSTICO RECIENTE QUE PRESENTAN ENFERMEDAD RESIDUAL MÍNIMA DESPUÉS DE SOMETERSE A AUTOTRASPLANTE DE CÉLULAS MADRE

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

A Phase 3 Study With Elranatamab Versus Lenalidomide in Patients With Newly Diagnosed Multiple Myeloma After Transplant

Estudio en fase III con elranatamab en comparación con lenalidomida en pacientes con mieloma múltiple de nuevo diagnóstico después del trasplante

A.4.1

Sponsor's protocol code number

C1071007

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Pfizer Inc.
B.1.3.4	Country	United States
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Pfizer Inc.
B.4.2	Country	United States
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Pfizer Inc.
B.5.2	Functional name of contact point	ClinicalTrials.gov Call Center
B.5.3	Address:
B.5.3.1	Street Address	235 East 42nd Street
B.5.3.2	Town/ city	New York
B.5.3.3	Post code	NY 10017
B.5.3.4	Country	United States
B.5.4	Telephone number	+18007181021
B.5.6	E-mail	ClinicalTrials.gov_Inquiries@pfizer.com

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	Yes
D.2.5.1	Orphan drug designation number	EU/3/21/2471
D.3 Description of the IMP
D.3.1	Product name	PF-06863135
D.3.2	Product code	PF-06863135
D.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Subcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Elranatamab
D.3.9.2	Current sponsor code	PF-06863135
D.3.9.3	Other descriptive name	Humanised IgG2k Fc-modified bispecific antibody against CD3 and BCMA
D.3.9.4	EV Substance Code	SUB205397
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	40
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Comparator
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	lenalidomide (ZELVINA)
D.2.1.1.2	Name of the Marketing Authorisation holder	ADALVO LIMITED
D.2.1.2	Country which granted the Marketing Authorisation	Iceland
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.4	Pharmaceutical form	Capsule, hard
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Lenalidomide
D.3.9.1	CAS number	191732-72-6
D.3.9.4	EV Substance Code	SUB25389
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	10
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 3
D.1.2 and D.1.3	IMP Role	Comparator
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	lenalidomide (ZELVINA)
D.2.1.1.2	Name of the Marketing Authorisation holder	ADALVO LIMITED
D.2.1.2	Country which granted the Marketing Authorisation	Iceland
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.4	Pharmaceutical form	Capsule, hard
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Lenalidomide
D.3.9.1	CAS number	191732-72-6
D.3.9.4	EV Substance Code	SUB25389
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	15
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 4
D.1.2 and D.1.3	IMP Role	Comparator
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	lenalidomide (ZELVINA)
D.2.1.1.2	Name of the Marketing Authorisation holder	ADALVO LIMITED
D.2.1.2	Country which granted the Marketing Authorisation	Iceland
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.4	Pharmaceutical form	Capsule, hard
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Lenalidomide
D.3.9.1	CAS number	191732-72-6
D.3.9.4	EV Substance Code	SUB25389
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	5
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

MULTIPLE MYELOMA

MIELOMA MÚLTIPLE

E.1.1.1

Medical condition in easily understood language

hematological B-cell malignancy characterized by dysregulated proliferation of BM (bone marrow) plasma cells.

malignidad hematológica de células B caracterizada por proliferación desregulada de células plasmáticas de MO (médula ósea)

E.1.1.2

Therapeutic area

Diseases [C] - Cancer [C04]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	21.0
E.1.2	Level	LLT
E.1.2	Classification code	10028228
E.1.2	Term	Multiple myeloma
E.1.2	System Organ Class	100000004864

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

To compare the efficacy of elranatamab (Arm A) versus lenalidomide (Arm B)

Comparar la eficacia de elranatamab (grupo A) frente a lenalidomida (grupo B).

E.2.2

Secondary objectives of the trial

Secondary Objectives:
• To compare the efficacy of Arm A vs Arm B
• To determine the safety and tolerability of elranatamab
• To evaluate the PK of elranatamab
• To evaluate the immunogenicity of elranatamab
• To evaluate the impact of study intervention on participant health-related quality of life (HRQoL)

Objetivos Secundarios:
• Comparar la eficacia del grupo A frente al grupo B.
• Evaluar la seguridad y tolerabilidad de elranatamab.
• Evaluar la FC de elranatamab.
• Evaluar la inmunogenia de elranatamab.
• Evaluar la repercusión de la intervención en el estudio respecto a la CVRS de los participantes

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Inclusion Criteria

- Diagnosis of MM as defined according to IMWG criteria (Rajkumar, 2014)
History of induction therapy and autologous stem cell transplant. Randomization must occur within 120 days from the stem cell transplant. For participants who receive consolidation therapy after ASCT, randomization must occur within 60 days of consolidation and within 6 months from ASCT.
- Partial Response or better according to IMWG criteria at the time of randomization
- MRD positive (≥10^-5) at screening by central laboratory NGS test (ClonoSEQ assay)
Must have an archival bone marrow aspirate sample(s) that identified the dominant malignant (index) clone that is used to track MRD status. This sample should preferably be collected before induction treatment (eg, at diagnosis) or before transplant.
- 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

Criterios de inclusión:

- Diagnóstico de MM definido según los criterios del IMWG (Rajkumar, 2014)
Historia de terapia de inducción y trasplante autólogo de células madre. La aleatorización debe ocurrir dentro de los 120 días posteriores al trasplante de células madre. Para los participantes que reciben terapia de consolidación después del ATCM, la aleatorización debe ocurrir dentro de los 60 días posteriores a la consolidación y dentro de los 6 meses posteriores al ATCM.
- Respuesta parcial o mejor según los criterios del IMWG en el momento de la aleatorización
- EMR positivo (≥10^-5) en la detección mediante la prueba NGS del laboratorio central (ensayo ClonoSEQ)
Debe tener una(s) muestra(s) de aspirado de médula ósea archivada (s) donde se identifiquen el clon maligno dominante (índice) que se usa para rastrear el estado de EMR. Esta muestra debe recogerse preferiblemente antes del tratamiento de inducción (p. ej., en el momento del diagnóstico) o antes del trasplante.
- Estado funcional ECOG ≤ 1
- Efectos agudos resueltos de cualquier terapia previa a la gravedad inicial o grado CTCAE ≤ 1
- No estar embarazada y dispuesta a usar anticonceptivos.

E.4

Principal exclusion criteria

Medical Conditions:
1. Plasma cell leukemia
2. POEMS syndrome
3. Systemic amyloid light chain amyloidosis
4. Impaired cardiovascular function or clinically significant cardiovascular diseases, defined as any of the following within 6 months prior to enrollment:
• Acute myocardial infarction or acute coronary syndromes (eg, unstable angina, coronary artery bypass graft, coronary angioplasty or stenting, symptomatic pericardial effusion);
• Clinically significant cardiac arrhythmias (eg, uncontrolled atrial fibrillation or uncontrolled paroxysmal supraventricular tachycardia);
• Thromboembolic or cerebrovascular events (eg, transient ischemic attack, cerebrovascular accident, deep vein thrombosis [unless associated with a central venous access complication] or pulmonary embolism);
• Prolonged QT syndrome or QTcF ≥470 msec at screening.
5. Ongoing Grade ≥ 3 peripheral sensory or motor neuropathy
6. History of GBS or GBS variants, or history of any Grade ≥3 peripheral motor polyneuropathy
7. Live attenuated vaccine within 4 weeks of the first dose.
8. Known or suspected hypersensitivity to the study interventions or any of its excipients.
9. 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.
10. Other surgical (including major surgery within 14 days prior to enrollment), medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator’s judgment, make the participant inappropriate for the study.
Prior/Concomitant Therapy:
11. Previous MM maintenance treatment
12. Prior treatment with BCMA targeted therapy
Prior/Concurrent Clinical Study Experience:
13. Previous administration with an investigational 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).
Diagnostic Assessments:
14. Serum pregnancy test (for females of childbearing potential) positive at screening.
15. Participants with active, uncontrolled bacterial, fungal, or viral infection, including (but not limited to) HBV, HCV, and known HIV or AIDS-related illness..
Other Exclusions:
16. Investigator site staff or Pfizer employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members.

Exclusion Criteria

- Plasma cell leukemia
- POEMS syndrome
- Systematic amyloid light chain amyloidosis
- Previous MM maintenance treatment
- Prior treatment with BCMA targeted therapy
- Any other active malignancy within 3 years prior to enrolment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ
- Active, uncontrolled bacterial, fungal, or viral infection, including (but not limited to) HBV, HCV, and known HIV or AIDS-related illness
- Previous administration with an investigational 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)

Enfermedades:
1. Leucemia de células plasmáticas
2. Síndrome de POEMS
3. Amiloidosis sistémica de cadenas ligeras amiloides
4. Deterioro de la función cardiovascular o de enfermedades cardiovasculares clínicamente significativas, definidas como cualquiera de los siguientes trastornos en los 6 meses anteriores a la inscripción:
- Infarto agudo de miocardio o síndromes coronarios agudos (p. ej., angina inestable, injerto de baipás de la arteria coronaria, angioplastia coronaria o colocación de endoprótesis vascular, derrame pericárdico sintomático);
- Arritmias cardiacas clínicamente significativas (p. ej., fibrilación auricular no controlada o taquicardia supraventricular paroxística no controlada).
- Acontecimientos cerebrovasculares o de tromboembolia (p. ej., accidente isquémico transitorio, accidente cerebrovascular, trombosis venosa profunda [a menos que se asocie a complicación del acceso venoso central] o embolia pulmonar).
- Síndrome de QT prolongado o QTcF ≥470 ms en la selección.
5. Neuropatía periférica sensitiva o motora de grado ≥3 en curso.
6. Antecedentes de Síndrome de Guillain-Barré (SGB) o variantes de SGB, o antecedentes de polineuropatía motora periférica de grado ≥3.
7. Vacuna viva atenuada en las 4 semanas posteriores a la primera dosis.
8. Sospecha o conocimiento de hipersensibilidad a los tratamientos del estudio o a cualquiera de sus excipientes.
9. Cualquier otra neoplasia maligna activa en los 3 años anteriores a la inscripción, excepto carcinoma basocelular o espinocelular, o carcinoma in situ tratados adecuadamente..
10. Otras afecciones quirúrgicas (incluida la cirugía mayor en los 14 días previos a la inscripción), médicas o psiquiátricas, incluidos los comportamientos o las ideas suicidas recientes (en el último año) o en activo, o anomalías de laboratorio que puedan aumentar el riesgo de la participación en el estudio o, a juicio del investigador, hagan que el participante no sea apto para el estudio.
Tratamiento previo/concomitante:
11. Tratamiento de mantenimiento previo para el MM
12. Tratamiento previo con tratamiento dirigido para BCMA
Experiencia en estudios clínicos previos o simultáneos:
13. Administración previa de un fármaco del estudio o vacuna en los 30 días (o según lo determine el requisito local) o 5 semividas previas a la primera dosis del tratamiento del estudio utilizado en este estudio (lo que lleve más tiempo).
Evaluaciones diagnósticas:
14. Prueba de embarazo en suero (en mujeres con capacidad de concebir) positiva en la selección.
15. Participantes con infección bacteriana, fúngica o vírica activa no controlada, incluidos (entre otros) el VHB, el VHC y enfermedades conocidas relacionadas con el VIH o el SIDA.
Otras exclusiones:
16. Empleados del centro de investigación o de Pfizer directamente implicados en la realización del estudio, empleados del centro supervisados de alguna otra manera por el investigador, y sus respectivos familiares.

E.5 End points

E.5.1

Primary end point(s)

• MRD negativity rate per IMWG as assessed via NGS
• PFS by BICR per IMWG

- Tasa de negatividad de ERM 12 meses después de la aleatorización según el IMWG evaluada mediante NGS.
- SSP mediante revisión central independiente enmascarada (RCIE) según el IMWG.

E.5.1.1

Timepoint(s) of evaluation of this end point

MRD negativity rate - 12 months after randomization per IMWG as assessed via NGS
PFS - Assessed approximately every 28 days and for approximately 5 years

- Tasa de negatividad de ERM 12 meses después de la aleatorización según el IMWG evaluada mediante NGS.
- SSP - evaluado aproximadamente cada 28 días y durante aproximadamente 5 años.

E.5.2

Secondary end point(s)

• PFS by investigator per IMWG
• Overall MRD negativity rate per IMWG
• Duration of MRD negativity per IMWG
• Sustained MRD negativity per IMWG
• CRR by BICR and investigator per IMWG
• DOCR by BICR and investigator per IMWG
• OS

• AEs and laboratory abnormalities as graded by NCI CTCAE v5.0.
• Severity of CRS and ICANS assessed according to ASTCT criteria (Lee et al, 2019).

• Pre- and postdose concentrations of elranatamab

• ADAs and NAbs against elranatamab

• EORTC QLQ-C30+MY20

- SSP por el investigador según el IMWG.
- Tasa global de negatividad de EMR según el IMWG.
- Duración de la negatividad de EMR según el IMWG.
- Negatividad de EMR sostenida según el IMWG.
- TRCA por RCIE y el investigador según el IMWG.
- DRCA por RCIE y el investigador según el IMWG.
- SG

E.5.2.1

Timepoint(s) of evaluation of this end point

• PFS - Assessed approx. every 28 days and for approx. 5 years
• MRD negativity rate (Overall, Duration and Sustained) - Assessed every 6 months and for approx. 5 years
• CRR & DOCR - Assessed approximately every 28 days and for approx. 5 years
• OS - Assessed For approx. 5 years
• AEs and laboratory abnormalities - Up to 90 days after last dose for AE frequency and at every cycle (each cycle ~ 28 days) for lab abnormalities
• Severity of CRS and ICANS - Assessed at every cycle
• Pre- and post-dose concentrations of elranatamab - Assessed approx. every 1 - 3 cycles
• ADAs and NAbs against elranatamab - Assessed approx. every 1 to 6 cycles
• EORTC QLQ-C30+MY20 - Assessed every cycle for year 1, every 3 cycles for year 2 and then once every 6 cycles

-SSP- Evaluada aprox. cada 28 días y durante aprox. 5 años.
-Tasa de negatividad de EMR (global, duración y sostenida) - Evaluada cada 6 meses y durante aprox. 5 años.
-TRCA y DRCA- evaluadas aprox. cada 28 días y durante aprox. 5 años.
-SG- Evaluada durante aprox. 5 años.
-AA y anomalías en el análisis- hasta 90 días de seguimiento tras la última dosis para la frecuencia de AA y para cada ciclo (cada ciclo ~ 28 días) para anomalías en el análisis.
-Gravedad del SLC y de los ICANS- evaluados en cada ciclo.
-Concentraciones de elranatamab antes y después de la dosis- evaluadas aprox. cada 1-3 ciclos
-AAF y AcN contra elranatamab- evaluadas aprox. cada 1 a 6 ciclos.
-AAF y AcN contra elranatamab- evaluadas cada ciclo para el año 1, cada 3 ciclos para el año 2 y después cada 6 ciclos.

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

Yes

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

Yes

E.6.13.1

Other scope of the trial description

Immunogenicity
Biomarkers
Genetic

Inmunogenicidad
Biomarcadores
Genética

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

Yes

E.8.2.2

Placebo

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

Yes

E.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

Australia

Austria

Belgium

Brazil

Canada

Czechia

Finland

France

Germany

Greece

Hungary

India

Israel

Italy

Japan

Korea, Republic of

Netherlands

Norway

Poland

Russian Federation

Spain

Sweden

Taiwan

Turkey

United States

E.8.7

Trial has a data monitoring committee

Yes

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

LVLS

Último paciente última visita

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

183

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

183

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.4.2

For a multinational trial

F.4.2.1

In the EEA

180

F.4.2.2

In the whole clinical trial

366

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

No study intervention will be provided to participants beyond the end of study. Availability of study intervention following closure of the study via expanded access/compassionate/continued use mechanism if the investigator and participant desire to continue intervention and if there is documented continued benefit from study intervention for the participant would be at the discretion of the sponsor and subject to study intervention availability and compliance with local laws and regulations.

No se proporcionará tratamiento tras el final del estudio. La disponibilidad de la intervención del estudio después del cierre del estudio a través de un mecanismo de acceso expandido/compasivo/uso continuo si el investigador y el participante desean continuar la intervención y si hay beneficio continuo documentado de la intervención del estudio para el participante sería a discreción del promotor y al estudiar la disponibilidad de la intervención y el cumplimiento de leyes y reglamentos locales

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2022-04-19

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2022-04-12

P. End of Trial
P.	End of Trial Status	Ongoing

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