Clinical Trials List
Protocol NumberC1071007
NCT Number(ClinicalTrials.gov Identfier)NCT05317416
2022-04-01 - 2029-10-31
Phase III
Not yet recruiting2
Recruiting3
ICD-10C90.00
Multiple myeloma not having achieved remission
ICD-10C90.02
Multiple myeloma in relapse
ICD-10Z51.12
Encounter for antineoplastic immunotherapy
ICD-9203.00
Multiple myeloma, without mention of remission
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
-
Sponsor
Pfizer
-
Trial scale
Multi-Regional Multi-Center
-
Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- Sheng-chieh Chou 無
- YAO CHI-YUAN 無
- 柯紀綸 無
- 林耘曲 無
- MING YAO 無
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
- Ching-Chan Lin 無
- Tzu-Ting Chen 無
- 陳珈妤 無
- Chen-Yuan Lin 無
- Chi-Ching Chen 無
- Yu-Min Liao 無
- Che-Hung Lin 無
- Ming-Yu Lien 無
- 王秀慈 無
- Ching Yun Hsieh Division of Hematology & Oncology
- Ming-Hung Tsai 未分科
- 鄭富銘 無
- 王幸婷 Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
- Po-Nan Wang Division of Hematology & Oncology
- 林潔 無
- HSUAN JEN SHIH 無
- Ming-Chung Kao 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Hao-Yuan Wang 無
- 陳玟均 無
- Po-Shen Ko 無
- Liang-Tsai Hsiao 無
- Ting-An Lin 無
- 蔡淳光 無
- Yao-Chung Liu 無
- Sheng-Hsuan Chien 無
- Jyh-Pyng Gau 未分科
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Multiple Myeloma
Objectives
Evaluate whether elranatamab monotherapy can provide clinical benefit compared to lenalidomide monotherapy (control) in participants with newly diagnosed multiple myeloma who are MRD-positive after undergoing autologous stem cell transplant.
Test Drug
Elranatamab
Lenalidomide
Lenalidomide
Active Ingredient
Elranatamab
Lenalidomide
Lenalidomide
Dosage Form
solution for injection
Capsules
Capsules
Dosage
40 mg/mL
5 mg, 10 mg, 15 mg
5 mg, 10 mg, 15 mg
Endpoints
• Minimal Residual Disease negativity rate per IMWG criteria as assessed via Next Generation Sequencing
• Progression Free Survival assessed by Blinded Independent Central review per IMWG response criteria
• Progression Free Survival assessed by Blinded Independent Central review per IMWG response criteria
Inclution Criteria
1. Participant’s age ≥ 18 years (or the minimum country-specific age of consent if >18)
at Visit 1 (Screening).
Male participants and female participants of childbearing potential must agree to
use methods of contraception.
2. Participants who are willing and able to comply with all scheduled visits, treatment
plan, laboratory tests, lifestyle considerations, and other study procedures.
3. Diagnosis of MM as defined according to IMWG criteria (Rajkumar et al, 2014).
History of 3 to 8 cycles of induction therapy for newly diagnosed MM, followed by
high-dose therapy and ASCT. 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.
4. PR or better according to IMWG criteria at the time of randomization.
5. MRD positive (≥10-5
) at screening by central laboratory NGS test (Adaptive
Biotechnologies clonoSEQ® assay).
Must have an archived bone marrow aspirate sample(s) that identifies the
dominant malignant (index) clone that is used to track MRD status by
central laboratory assessment (Adaptive Biotechnologies clonoSEQ® assay).
This sample should preferably be collected before induction treatment (eg, at
diagnosis) or before transplant. A sample collected after transplant may be
accepted with sponsor approval. If a participant has an Adaptive
Biotechnologies' clonoSEQ® MRD assay result from previous testing that
identifies the index multiple myeloma clone, and the result is retrievable and
useable in this study, an archival sample will not be required.
A bone marrow aspirate sample collected at screening is required to
determine MRD status.
6. ECOG performance status ≤1.
7. LVEF ≥40% as determined by a MUGA scan or ECHO.
8. Adequate hepatic function characterized by the following:
Total bilirubin ≤2 × ULN (≤3 × ULN if documented Gilbert’s syndrome);
AST ≤2.5 × ULN; and
ALT ≤2.5 × ULN.
9. Adequate renal function defined by an estimated creatinine clearance ≥30 mL/min
(according to the Cockcroft-Gault formula, by 24-hour urine collection for creatinine
clearance, or according to local institutional standard method).
10. Adequate post-ASCT recovery of BM function characterized by the following:
ANC ≥1.0 × 109
/L (use of G-CSF is permitted if completed at least 7 days prior to
planned start of dosing, G-CSF should not be used to reach this level);
Platelets ≥75 × 109
/L (transfusion support is permitted if completed at least 7 days
prior to planned start of dosing); and
Hemoglobin ≥8 g/dL (transfusion support is permitted if completed at least
14 days prior to planned start of dosing).
11. Corrected serum calcium ≤14 mg/dL (≤3.5 mmol/L).
12. Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade ≤ 1.
13. Capable of giving signed informed consent, which includes compliance with the
requirements and restrictions listed in the ICD and in this protocol.
at Visit 1 (Screening).
Male participants and female participants of childbearing potential must agree to
use methods of contraception.
2. Participants who are willing and able to comply with all scheduled visits, treatment
plan, laboratory tests, lifestyle considerations, and other study procedures.
3. Diagnosis of MM as defined according to IMWG criteria (Rajkumar et al, 2014).
History of 3 to 8 cycles of induction therapy for newly diagnosed MM, followed by
high-dose therapy and ASCT. 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.
4. PR or better according to IMWG criteria at the time of randomization.
5. MRD positive (≥10-5
) at screening by central laboratory NGS test (Adaptive
Biotechnologies clonoSEQ® assay).
Must have an archived bone marrow aspirate sample(s) that identifies the
dominant malignant (index) clone that is used to track MRD status by
central laboratory assessment (Adaptive Biotechnologies clonoSEQ® assay).
This sample should preferably be collected before induction treatment (eg, at
diagnosis) or before transplant. A sample collected after transplant may be
accepted with sponsor approval. If a participant has an Adaptive
Biotechnologies' clonoSEQ® MRD assay result from previous testing that
identifies the index multiple myeloma clone, and the result is retrievable and
useable in this study, an archival sample will not be required.
A bone marrow aspirate sample collected at screening is required to
determine MRD status.
6. ECOG performance status ≤1.
7. LVEF ≥40% as determined by a MUGA scan or ECHO.
8. Adequate hepatic function characterized by the following:
Total bilirubin ≤2 × ULN (≤3 × ULN if documented Gilbert’s syndrome);
AST ≤2.5 × ULN; and
ALT ≤2.5 × ULN.
9. Adequate renal function defined by an estimated creatinine clearance ≥30 mL/min
(according to the Cockcroft-Gault formula, by 24-hour urine collection for creatinine
clearance, or according to local institutional standard method).
10. Adequate post-ASCT recovery of BM function characterized by the following:
ANC ≥1.0 × 109
/L (use of G-CSF is permitted if completed at least 7 days prior to
planned start of dosing, G-CSF should not be used to reach this level);
Platelets ≥75 × 109
/L (transfusion support is permitted if completed at least 7 days
prior to planned start of dosing); and
Hemoglobin ≥8 g/dL (transfusion support is permitted if completed at least
14 days prior to planned start of dosing).
11. Corrected serum calcium ≤14 mg/dL (≤3.5 mmol/L).
12. Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade ≤ 1.
13. Capable of giving signed informed consent, which includes compliance with the
requirements and restrictions listed in the ICD and in this protocol.
Exclusion Criteria
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.
11. Previous MM maintenance treatment
12. Prior treatment with BCMA targeted therapy
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).
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.
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.
11. Previous MM maintenance treatment
12. Prior treatment with BCMA targeted therapy
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).
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.
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.
11. Previous MM maintenance treatment
12. Prior treatment with BCMA targeted therapy
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).
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.
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.
11. Previous MM maintenance treatment
12. Prior treatment with BCMA targeted therapy
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).
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.
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.
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.
11. Previous MM maintenance treatment
12. Prior treatment with BCMA targeted therapy
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).
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.
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.
11. Previous MM maintenance treatment
12. Prior treatment with BCMA targeted therapy
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).
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.
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.
11. Previous MM maintenance treatment
12. Prior treatment with BCMA targeted therapy
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).
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.
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.
11. Previous MM maintenance treatment
12. Prior treatment with BCMA targeted therapy
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).
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.
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.
The Estimated Number of Participants
-
Taiwan
40 participants
-
Global
760 participants
