This study has been transitioned to CTIS with ID 2023-510384-36-00 check the CTIS register for the current data. The primary objective of this study is to compare the efficacy of teclistamab in combination with lenalidomide (Tec-Len) with that of…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Multiple Myeloma
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To compare the efficacy of Teclistamab in Combination and Teclistamab alone
with Lenalidomide maintenance compared to Lenalidomide alone
-endpoint: PFS
Secondary outcome
• To further compare the efficacy of Tec-Len to Len, and the efficacy of Tec to
Len in the maintenance setting
o Endpoints:
* CR conversion
* MRD negative conversion
* CR or better
* MRD negative CR
* Sustained MRD negativity defined as two negative MRD results confirmed
minimum 1 year apart
* OS
* TTNT
* PFS after next line of therapy (PFS2) from randomization
• To assess the safety profile of Teclistamab in Combination with Lenalidomide
and Teclistamab alone
o Endpoints:
* Incidence and severity of AEs
• To characterize the PK of Teclistamab in Combination with Lenalidomide and
Teclistamab alone
o Endpoints:
* PK parameters using population PK approach
• To assess the immunogenicity of Teclistamab in Combination with Lenalidomide
and Teclistamab alone
o Endpoints:
* Presence and activity of ADAs to teclistamab
• To evaluate the impact of treatment with Teclistamab in Combination with
Lenalidomide and Teclistamab alone on PROs compared with Lenalidomide
o Endpoints:
* Time to worsening in overall HRQoL, symptoms, and functioning
* Change from baseline in overall HRQoL, symptoms, and functioning
Background summary
Synopsis
Phase 3 Study of Teclistamab in Combination With Lenalidomide and Teclistamab
Alone versus Lenalidomide Alone in Participants With Newly Diagnosed Multiple
Myeloma as Maintenance Therapy Following Autologous Stem Cell Transplantation
Teclistamab (also known as JNJ-64007957) is a humanized IgG4-PAA bispecific
antibody that binds the CD3 receptor complex on T cells and BCMA on plasma
cells. With its dual binding sites, teclistamab is able to draw CD3+ T cells in
close proximity to myeloma cells, resulting in T cell activation and subsequent
lysis of BCMA+ cells that is mediated by secreted perforin and various
granzymes stored in the secretory vesicles of cytotoxic T cells.
Hypothesis
The primary hypothesis of this study is that maintenance with Tec-Len and Tec
will significantly improve PFS compared with maintenance with Len in
participants with newly diagnosed multiple myeloma after ASCT.
Study objective
This study has been transitioned to CTIS with ID 2023-510384-36-00 check the CTIS register for the current data.
The primary objective of this study is to compare the efficacy of teclistamab
in combination with lenalidomide (Tec-Len) with that of lenalidomide
monotherapy(Len), and the efficacy of teclistamab monotherapy (Tec) with that
of lenalidomide monotherapy (Len) in the maintenance setting, as assessed by
PFS. Secondary objectives include further comparison of efficacy (CR or better,
MRD negative CR, sustained MRD negativity, CR and MRD negative conversion, PFS
after next line of therapy (PFS2), time to next treatment (TTNT), OS), and also
safety, PK, and immunogenicity.
Study design
This is a multicenter, randomized, open-label, Phase 3 study in participants
with newly diagnosed multiple myeloma who have completed induction therapy
followed by ASCT, with or without consolidation. The randomized portion of the
study will be conducted in 3 phases: Screening (up to 28 days), Treatment, and
Follow-up.
Prior to the start of the randomized portion of the study, a first safety
run-in (SRI1) was conducted and hascompleted enrollment. Participants in SRI1
are receiving Tec-Len for a duration of 2 years or until confirmed progressive
disease, death, intolerable toxicity, or consent withdrawal, whichever occurs
first. Safety evaluation was performed by the IDMC and the Joint Steering
Committee after at least 20 participants received at least 2 cycles of
treatment. Upon review of the safety data, the IDMC recommended to continue the
study unmodified. However, based on emerging data from MajesTEC-1 suggesting a
reduction in new onset of severe infections and durable responses with less
frequent treatment dosing, it was decided to further optimize the teclistamab
dosing schedule. Therefore, a second safety run-in (SRI2) will be conducted
with Q4W teclistamab dosing from Cycle 2. SRI2 will include 2 cohorts, one with
TecLen (SRI2 Tec-Len) and one with Tec (SRI2 Tec). A safety evaluation will be
performed by the IDMC and JSC after at least 20 participants have received at
least 2 cycles of treatment.
If no safety signal is observed during the safety run-in, the randomized
portion of the study will begin, during which participants will be randomized
1:1:1 to receive Tec-Len (Arm A), Len (Arm B), or Tec (Arm C). Participants in
the safety run-in will not be randomized but will continue their assigned
treatment. Participants will receive study treatment continuously for 2 years
or until confirmed progressive disease, death, intolerable toxicity, or consent
withdrawal, whichever occurs first. Participants in Arm A who achieve a CR or
better after 1 year of treatment will discontinue teclistamab but continue
lenalidomide for the second year.
Upon completion or discontinuation of treatment, an EOT Visit will be
conducted. Thereafter, the participants will continue in the Follow-up Phase
until withdrawal of consent, loss to follow-up, death, or end of study,
whichever occurs first. The study will continue until approximately 380 deaths
are accrued in the pooled Tec-Len and Len arms and approximately 380 deaths
have also been accrued in the pooled Tec and Len arms.
An IDMC will be commissioned for this study.
Intervention
Treatment schedule various arms:
Teclistamab Subcutaneous (SRI1)
Cycle 1:
Step-up dose 1: 0.06mg/kg (day 1)
Step-up dose 2: 0.3mg/kg (day 3)
Treatment dose: 1.5mg/kg (day 8, 15 and 22)
Cycle 2: Treatment dose 1.5mg/kg (day 1, 8, 15 and 22)
Cycles 3-6: Treatment dose 3mg/kg Q2W (day 1 and 15)
Cycles 7-26: Treatment dose 3mg/kg Q4W (day 1 all cycles)
Teclistamab Subcutaneous (SRI2, Arm A and Arm C)
Cycle 1:
Step-up dose 1: 0.06mg/kg (day 1)
Step-up dose 2: 0.3mg/kg (day 3)
Treatment dose: 1.5mg/kg (day 8 and 15)
Cycles 2-26: Treatment dose 3mg/kg Q4W on day 1 of every cycle
Lenalidomide Oral (SRI1, SRI2 Tec-Len and Arm A)
Cycles 2-4: 10mg per day for 28 days
Cycles 5-26: 15mg per day for 28 days
Lenalidomide Oral (Arm B)
Cycles 1-3: 10mg per day for 28 days
Cycles 4-26: 15mg per day for 28 days
Step 3: Follow up
• Treatment Group A: Tec-Len (standard treatment + Teclistamab), Treatment
Group B: Len (standard treatment) and Treatment Group C: Tec (monotherapy)
After completion of the maintenance treatment, visits will occur every 8 weeks
for laboratory assessments to gather information about how your myeloma
responds.
After the disease progresses, we will collect follow up information every 4
months about your condition, the new Multiple Myeloma treatments you receive,
responses to those treatments, questionnaires, any new cancer development and
survival. This information can be obtained during regular doctor visits or via
telephone contacts every 4 months, no extra visits for this part of the trial
are required.
After you finish participating in the study, if needed, the study doctor might
also access and review public records in order to collect survival information,
as permitted by local regulation.
Study burden and risks
Lenalidomide
The following side effects are very common (may affect more than 1 in 10
people) side effects of Lenalidomide:
• Low white blood cells (neutropenia; increasing risk of getting an infection),
low platelets (thrombocytopenia; increased risk of bruising or bleeding) have
been observed which may require reduction or interruption of the dose of
Lenalidomide.
• Diarrhea
• Fatigue, lack of energy
• Low red blood cells (anemia)
• Constipation
• Swelling of hands, feet or limbs
• Muscle cramp/spasms
• Pain: back, bone, abdominal or joint
• Nausea
• Fever
• Infection of the upper respiratory tract, including nose, sinuses, and/or
throat
• Cough
• Rash
• Difficulty sleeping
• Shortness of breath
• Dizziness
• Decreased appetite/decrease in weight
• Tremor, shaking or trembling
• Infection of the lung
• Bronchitis - infection of the lower airways
• Blot clots
• Pain or swelling in your legs, especially in your lower leg or calves due to
blood clots in the veins of your leg (deep vein thrombosis)
• Sudden pain in your chest or difficulty in breathing due to blood clots in
the arteries leading to your lungs (pulmonary embolism)
• Bleeding disorder
• High blood sugar
• Decreased calcium in the blood
• Depression
• Headache
• Numbness/tingling of hands, feet or limbs (neuropathy)
• Bleeding from the nose
• Inflammation of stomach and/or intestines
• Vomiting
• Itch
• Renal failure (including acute) - kidney failure which results in build-up of
waste products in the body
• Influenza like illness
• Dry skin
• Decreased potassium in the blood
• Liver disorders
• Distortion of taste
Teclistamab
Any drug has risks and side effects which may vary from person to person. Side
effects may be mild to very severe. Most side effects will go away after
treatment is stopped, but some may be long lasting. Side effects seen in
research studies can result from a patient*s disease, the study drug, other
drugs, other diseases, or a combination of these. This section gives you the
information known so far about side effects seen with the study drug
Teclistamab based on clinical experience with Teclistamab to date.
As of 16 March 2022, approximately 668 clinical study patients with Multiple
Myeloma have been treated with Teclistamab. Approximately, 90 patients were
treated with Teclistamab IV (via IV: infusion directly into the vein) and
approximately 578 patients were treated with Teclistamab SC (subcutaneous,
underneath the skin). Of the 668 patients, approximately 383 received
Teclistamab alone, and 285 patients received Teclistamab in combination with
other therapies.
Not all the possible discomforts, side effects and risks related to study drug
treatment are known. New side effects could happen. Your study doctor will
monitor, and you will receive appropriate care if side effects happen. Please
tell your study doctor right away if you have any of the side effects described
below or any other ones not listed. You will be told of any new findings that
may affect your decision to continue in this study.
Body System Very Common
(may affect more than 1 in 10 people) Common
(may affect up to 1 in 10 people)
Immune system • Cytokine Release Syndrome (see separate section below for
details)
• Hypogammaglobulinemia (see separate section below for details)
Infections
(see separate section below for details) • Upper respiratory tract infection •
Covid-19
• Infection of the lung (Pneumonia) • Sepsis (a life-threatening condition that
arises when the body's response to an infection injures its own tissues and
organs) • cellulitus
Blood Cell Effects
• Low white blood cells (including neutropenia, lymphopenia, leukopenia)
• Low platelets (Thrombocytopenia)
• Low red blood cells (Anemia)
Metabolism and Nutrition • Low blood phosphate levels (Hypophosphataemia)
• Low blood magnesium levels (Hypomagnesaemia)
• Low blood potassium levels (Hypokalaemia)
• High blood calcium levels (Hypercalcaemia)
• Decreased appetite • Low blood calcium levels (Hypocalcaemia)
• Low blood sodium levels
• (Hyponatraemia)
• Low blood albumin (Hypoalbuminaemia)
Nervous system • Headache
• Abnormal sensation including numbness/tingling of hands, feet, or limbs
(Neuropathy peripheral) • Disorder of the brain (Encephalopathy)
• Immune effector cell-associated neurotoxicity syndrome (ICANS) (see
*Neurologic Side Effects* below for details)
Vascular
• High blood pressure
• Bleeding
Lung • Cough • dyspneu • hypoxy
Gastrointestinal • Nausea
• Diarrhea
• Constipation
• Vomiting • Pancreas blood test high
Muscles, bone, and connective tissue • Pain in muscles or bones
(Musculoskeletal pain)
General disorders and administration site conditions • Injection site reaction
(see separate section below for details)
• Tiredness (Fatigue)
• Pain (see separate section below for details)
• Fever
• Swelling of hands, feet, or limbs (Edema)
Liver • Liver blood tests high
Kidney • Kidney blood test abnormal
Cytokine Release Syndrome (CRS)
CRS is a complication that can happen due to the activation of immune cells and
in a few events can be severe, life threatening, or even lead to death. The
signs and symptoms of CRS with Teclistamab may include fever, chills, abnormal
blood pressure, trouble breathing, elevated heart rate, headache, tired or
weakness, dizziness, nausea, vomiting and abnormal liver function tests. CRS
has occurred in approximately 72% of the patients treated with Teclistamab.
Most cases occurred within the first few doses and so far have been mild or
moderate.,
You will be given lower doses of Teclistamab (called step-up doses) before
getting the full treatment dose and medications including steroids,
paracetamol/acetaminophen, and an antihistamine, will be given before
Teclistamab at the initial doses to help with the management of CRS.
Your study doctor will check and monitor you for symptoms of CRS. To treat CRS,
you may receive a drug called tocilizumab. Tocilizumab is also used to treat
COVID-19 patients, and due to the pandemic, tocilizumab might be hard to get.
If your study doctor is not able to obtain tocilizumab, or if tocilizumab alone
may not be enough to manage your symptoms, he/she may use alternative
medications to treat CRS such as siltuximab, anakinra, and/or steroids. While
these alternative treatments have been used to manage CRS following
investigational agents similar to the one being studied in this clinical trial,
none are approved and there is limited information available to support the use
of siltuximab and anakinra in comparison with tocilizumab for the management of
CRS. You may also receive steroids again. Your doctor will explain the side
effects of Tocilizumab, steroids, and any other treatment you may need. If the
CRS is severe, supportive care and medication may be required, and treatment
with the study drug may be interrupted or discontinued.
Neurologic Side Effects
Neurological side effects may occur that include headaches or a condition named
* Immune Effector Cell-Associated Neurotoxicity Syndrome* (ICANS). ICANs can be
severe, life threatening, or even lead to death. Neurologic side effects may
include sleepiness, confusion, speech disorder, difficulty writing, delirium,
numbness/tingling of hands, feet or limbs, slow thinking, and altered mental
state. Most have been mild or moderate except for two severe events (delirium
and a
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Listed location countries
Age
Inclusion criteria
1. >=18 years of age (and the legal age of consent in the jurisdiction in which
the study is taking place) at the time of informed consent.
2. Must have a new diagnosis of symptomatic multiple myeloma according to
International Myeloma Working Group (IMWG) criteria and have received 4 to 6
cycles of 3 or 4 drug-induction therapy that includes a proteasome inhibitor
and/or an IMiD with or without anti-CD38 monoclonal antibody and a single or
tandem ASCT. Post ASCT consolidation is permitted for up to 2 cycles as long as
the total number of induction plus consolidation cycles does not exceed 6.
Participants must complete all previous treatment prior to screening and at
least 7 days prior to randomization, except for cytotoxic therapy, which must
be completed at least 21 days before randomization.
3. Must have received only one line of therapy and achieved at least a partial
response (>=PR) as per IMWG 2016 response criteria, based on the investigator's
assessment. Participants with plasmacytomas at the time of diagnosis must meet
IMWG 2016 response criteria for >=PR based on repeat imaging during screening
utilizing the same modality (Kumar 2016).
4. Must not be intolerant to the starting dose of lenalidomide (see Table 11).
5. Must have received high-dose chemotherapy and ASCT within 12 months of the
start of induction therapy and be within 6 months of the last ASCT at the time
of randomization or at the time of Sponsor approval for participants in safety
run-in.
6. Must not have received any maintenance therapy.
7. Have an Eastern Cooperative Oncology Group (ECOG) performance status score
of 0-2 at screening and immediately prior to the start of administration of
study treatment (see Appendix 7).
8. Have clinical laboratory values meeting the following criteria
Hematology
Hemoglobin *8.0 g/dL (** mmol/L; without prior RBC transfusion within 7 days
before the laboratory test; recombinant human erythropoietin use is permitted)
Platelets >=75×109/L (without transfusion support or thrombopoietin receptor
agonist within 7 days before the laboratory test)
Absolute neutrophil count >=1.0×109/L (prior growth factor support is permitted
but must be without support for 7 days for G-CSF or GM-CSF or 14 days for
pegylated-G-CSF)
Chemistry
AST and ALT <=2.5× upper limit of normal (ULN)
Total bilirubin <=1.5×ULN; except in participants with congenital bilirubinemia,
such as Gilbert syndrome (in which case direct bilirubin <=1.5×ULN is required)
Serum calcium corrected for albumin <=14 mg/dL (<=3.5 mmol/L) or free ionized
calcium <=6.5 mg/dL (<=1.6 mmol/L; see Appendix 10.
Abbreviations: ALT=alanine aminotransferase; AST=aspartate aminotransferase;
CrCl=creatinine clearance; G-CSF=granulocyte colony-stimulating factor;
GM-CSF=granulocyte-macrophage colony-stimulating factor; RBC=red blood cell;
ULN=upper limit of normal
9. A woman of childbearing potential must have a negative serum pregnancy test
within 10-14 days prior to the start of study treatment and again either a
serum or urine pregnancy test within 24 hours of the start of study treatment
and must agree to further serum or urine pregnancy tests during the study.
10. A woman must be (as defined in Appendix 11):
a) Not of childbearing potential, or
b) Of childbearing potential
c) Practicing 2 reliable methods of contraception simultaneously including one
highly effective method of contraception and one other effective method of
contraception (see Appendix 11) starting 4 weeks prior to dosing, throughout
the study including during dose interruptions and for a minimum of 4 weeks
after the last dose of lenalidomide or for a minimum of 6 months after the last
dose of teclistamab, whichever occurs later. For participants who are of
childbearing potential, see Section 6.11.3 for details regarding concomitant
use of estrogen containing products and lenalidomide.
NOTE: If a woman becomes of childbearing potential after start of the study the
woman must comply with point (b) as described above.
NOTE: Sexual abstinence is considered a highly effective method only if defined
as refraining from heterosexual intercourse during the entire period of risk
associated with the study treatment. The reliability of sexual abstinence needs
to be evaluated in relation to the duration of the study and the preferred and
usual lifestyle of the participant.
11. A woman must agree not to donate eggs (ova, oocytes) or freeze for future
use, for the purposes of assisted reproduction during the study and for a
minimum of 4 weeks after the last dose of lenalidomide or for a minimum of 6
months after the last dose of teclistamab, whichever occurs later.
12. A man must wear a condom (with or without spermicidal
foam/gel/film/cream/suppository) when engaging in any activity that allows for
passage of ejaculate to another person during the study and for a minimum of 4
weeks after the last dose of lenalidomide or for a minimum of 3 months after
the last dose of teclistamab, whichever occurs later. If his female partner is
of childbearing potential, the male participant must use condom (with or
without spermicide) and the female partner of the male participant must also be
practicing a highly effective method of contraception (see Appendix 11).
NOTE: If the male participant is vasectomized, he still must wear a condom
(with or without spermicidal foam/gel/film/cream/suppository), but his female
partner is not required to use contraception.
13. A male participant must agree not to donate sperm for the purpose of
reproduction during the study and for a minimum of 4 weeks after the last dose
of lenalidomide or for a minimum of 90 days after receiving the last dose of
teclistamab, whichever occurs later.
14. Must be willing and able to adhere to the lifestyle restrictions specified
in this protocol (Section 5.3).
15. Must sign an informed consent form (ICF) (or their legally acceptable
representative must sign) indicating that the participant understands the
purpose of, and procedures required for, the study and is willing to
participate in the study.
Exclusion criteria
1. Received any prior BCMA-directed therapy. 2. Any previous therapy with an
immune cell redirecting agent or gene modified adoptive cell therapy (eg,
chimeric antigen receptor modified T cells, NK cells). 3. Discontinued
treatment due to any AE related to lenalidomide as determined by the
investigator. 4. History of allogeneic stem cell transplantation or prior organ
transplant requiring immunosuppressive therapy. 5. Progressive disease as per
IMWG 2016 response criteria at any time prior to randomization or C1D1 for
participants in the safety run in. 6. Radiotherapy within 14 days or focal
radiation within 7 days of C1D1. 7. Received a cumulative dose of
corticosteroids equivalent to >=140 mg of dexamethasone within the 14 days prior
to C1D1 (see Appendix 12). 8. Received a live, attenuated vaccine within 4
weeks before C1D1. Non-live vaccines or non-replicating authorized for
emergency use (eg. COVID-19) are allowed. 9. Myelodysplastic syndrome or any
malignancy that has progressed or required treatment change in the last 24
months). The only allowed exceptions are malignancies treated within the last
24 months that are considered completely cured: a) Non-muscle invasive bladder
cancer (solitary Ta-PUN-LMP or low grade, <3 cm, no CIS) b) Skin cancer
(non-melanoma skin cancer treated with curative therapy melanoma or localized
or melanoma) treated with curative surgical resection alone). c) Noninvasive
cervical cancer d) Breast cancer: adequately treated lobular carcinoma in situ
or ductal carcinoma in situ, or localized breast cancer and receiving
antihormonal agents. e) e) Localized prostate cancer (N0M0) with a Gleason
Score <7a, treated locally only (RP/RT/focal treatment) f) Other malignancy
that is considered cured with minimal risk of recurrence. NOTE: In the event of
any questions, consult with the sponsor*s medical monitor prior to enrolling a
participant. 10. Plasma cell leukemia, smoldering multiple myeloma,
Waldenstro*m*s macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly,
endocrinopathy, monoclonal protein, and skin changes), or primary light chain
amyloidosis. 11. Central nervous system involvement or exhibits clinical signs
of meningeal involvement of multiple myeloma. If either is suspected, brain
magnetic resonance imaging (MRI) and lumbar cytology are required. 12. Stroke,
transient ischemic attack or seizure within 6 months of C1D1. 13.
Contraindications or life-threatening allergies, hypersensitivity, or
intolerance to any study treatment or its excipients (refer to IB and most
recent applicable RSI). 14. Participant is pregnant or breast-feeding or
planning to become pregnant while enrolled in this study or within 6 months
after the last dose of study drug. 15. Participant plans to father a child
while enrolled in this study or within 90 days after the last dose of study
drug. 16. Presence of the following cardiac conditions: a) New York Heart
Association stage III or IV congestive heart failure b) Myocardial infarction,
or coronary artery bypass graft <=6 months prior to C1D1 c) History of
clinically significant ventricular arrhythmia or unexplained syncope, not
believed to be vasovagal in nature or due to dehydration d) Uncontrolled
cardiac arrhythmia or clinically significant electrocardiogram (ECG)
abnormalities. 17. Any of the following: a) Human immunodeficiency (HIV)
virus-positive participants with 1 or more of the following: * History of
acquired immune deficiency syndrome (AIDS)-defining conditions * CD4 count <350
cells/mm3 at screening * Detectable viral load during screening or within six
months prior to screening (see Table 2) * Not receiving highly active
antiretroviral therapy (ART) * Had a change in antiretroviral therapy within 6
months of the start of screening * Receiving antiretroviral therapy that may
interfere with study treatment as assessed after discussion with the Medical
Monitor 18. Hepatitis B infection (ie, HBsAg or HBV-DNA positive): In the event
the infection status is unclear, quantitative viral levels are necessary to
determine the infection status see Section 8.3.5 for further required
assessments. 19. Active hepatitis C infection as measured by positive hepatitis
C virus (HCV)- ribonucleic acid (RNA) testing. Participants with a history of
HCV antibody positivity must undergo HCV-RNA testing. If a participant with
history of chronic HCV infection (defined as both HCV antibody and HCV-RNA
positive) completed antiviral therapy and has undetectable HCV-RNA 12 weeks
following the completion of therapy, the participant is eligible for the study.
20. Concurrent medical or psychiatric condition or disease, that is likely to
interfere with study procedures or results, or that in the opinion of the
investigator would constitute a hazard for participating in this study, such
as: a) Grade 3 or greater peripheral neuropathy b) Acute diffuse infiltrative
pulmonary disease c) Evidence of active systemic viral, fungal, or bacterial
infection, requiring systemic antimicrobial therapy d) History of autoimmune
disease with the exception of: i. vitiligo not on systemic therapy ii. type I
diabetes iii. prior autoimmune thyroid disease that is currently euthyroid
based on clinical symptoms and laboratory testing e) Disabling psychiatric
conditions (eg, alcohol or drug abuse), severe dementia, or altered mental
status f) Any other issue that would impair the ability of the participant to
receive or tolerate the planned treatment at the investigational site, to
understand informed consent or any condition for which, in the opinion of the
investigator, participation would not be in the best interest of the
participant (eg, compromise the well-being) or that could prevent, limit, or
confound the protocol-specified assessments g) History of non-compliance with
recommended medical treatments 21. Participant had major surgery or had
significant traumatic injury within 2 weeks prior to the start of
administration of study treatment, or has not fully recovered from an earlier
surgery, or has major surgery planned during the time the participant is
expected to participate in the study or within 2 weeks after administration of
the last dose of study treatment. NOTE: Participants with planned surgical
procedures to be conducted under local anesthesia may participate. Kyphoplasty
or vertebroplasty are not considered major surgery. If there is a question
about whether a procedure is considered a major surgery, the investigator must
consult with the sponsor and resolve any issues before enrolling a participant
in the study. 22. Have received an investigational drug (including
investigational vaccines) or used an invasive investigational medical device
within 4 weeks or 5 PK half-lives, whichever is longer, before C1D1 or is
currently enrolled in an interventional investigational study except if only
long term survival data is collected and after Sponsor approval is obtained.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EU-CTR | CTIS2023-510384-36-00 |
| EudraCT | EUCTR2021-002531-27-NL |
| CCMO | NL79676.056.22 |