Vous pouvez participer si
1. Be ≥18 years of age.
2. Sign an informed consent form (ICF) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study, including the requirement to provide information during the Posttreatment Follow-up Period. Consent must be obtained prior to the initiation of any study-related tests or procedures that are not part of standard of care for the participant’s disease.
3. Have documented initial diagnosis of multiple myeloma according to IMWG diagnostic criteria
4. Meet treatment regimen-specific requirements as outlined in the study protocol.
5. Have documented evidence of progressive disease based on investigator’s determination of response by the IMWG 2016 criteria on their last line of therapy or within 12 months thereof. Also, participants with documented evidence of progressive disease within the previous 6 months and who are refractory to their most recent line of therapy are eligible.
6. Have measurable disease at screening as defined by at least one of the following:
a. Serum M-protein level ≥1.0 g/dL; or
b. Urine M-protein level ≥200 mg/24 hours; or
c. Light chain multiple myeloma: Serum Ig free light chain (FLC) ≥10 mg/dL and abnormal serum Ig kappa lambda FLC ratio.
7. Have an ECOG performance status score of 0 or 1 at screening and immediately before the start of study treatment administration.
8. Have clinical laboratory values during the Screening Period as specified in the study protocol.
9. A woman of childbearing potential must have a negative serum (β-hCG) pregnancy test at screening and a negative urine or serum pregnancy test within 24 hours before the start of study treatment administration.
10. A woman must be:
a. Not of childbearing potential, or
b. Of childbearing potential and
1) Practicing a highly effective, preferably user-independent method of contraception (failure rate of a) For participants enrolled in IMiD-containing regimens (Treatment Regimens A and B), women of childbearing potential must be on 2 methods of reliable birth control simultaneously while receiving study treatment and until 100 days after last dose of study treatment: one highly effective form of contraception (tubal ligation, intrauterine device, hormonal [oral, injectable, transdermal patches, vaginal rings, or implants], or partner’s vasectomy), and 1 additional effective contraceptive method (male latex or synthetic condom, diaphragm, or cervical cap).
b) For participants enrolled in Treatment Regimen C, a woman of childbearing potential using oral contraceptives must use an additional contraceptive method. Potential interactions between hormonal contraception and teclistamab have not been formally studied. Therefore, it is unknown whether teclistamab may reduce the efficacy of the contraception method.
2) Agree to pregnancy testing (serum or urine) within 100 days after the last dose of study treatment.
11. A man must wear a condom when engaging in any activity that allows for passage of ejaculate to another person during the study and for 100 days after the last dose of study treatme
nt. Male participants should also be advised of the benefit for a female partner to use a highly effective method of contraception as condoms may break or leak.
12. A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for at least 100 days after the last dose of study treatment.
13. A man must agree not to donate sperm or semen for reproduction during the study and for a minimum of 100 days after receiving the last dose of study treatment.
14. Be willing and able to adhere to the lifestyle restrictions specified in the protocol, including adherence to the applicable IMiD global PPP or local IMiD PPP/REMS program for all participants receiving Treatment Regimens A or B.
Vous ne pouvez pas participer si
1. Prior treatment with any therapy that targets BCMA.
2. Prior antitumor therapy as follows, in the specified time frame prior to the first dose of study treatment:
a. Targeted therapy, epigenetic therapy, or treatment with an investigational drug or an invasive investigational medical device within 21 days or at least 5 half-lives, whichever is less.
b. Gene-modified adoptive cell therapy (eg, CAR modified T cells, NK cells) within 3 months.
c. mAb treatment for multiple myeloma within 21 days.
d. Cytotoxic therapy within 21 days.
e. PI therapy within 14 days.
f. Immunomodulatory agent therapy within 7 days.
g. Radiotherapy within 14 days. However, if palliative focal radiation is used, the participant is eligible irrespective of the end date of radiotherapy.
3. Live, attenuated vaccine within 4 weeks before the first dose of study treatment, unless approved by sponsor.
4. Non-hematologic toxicity from prior anticancer therapy that has not resolved to baseline levels or to Grade ≤1 (except alopecia [any grade] or peripheral neuropathy Grade ≤3). EXCEPTION: Peripheral neuropathy Grade >2 is exclusionary for participants in Treatment Regimen B.
5. Received a cumulative dose of corticosteroids equivalent to ≥140 mg of prednisone within the 14-day period before the start of study treatment administration.
6. Received either of the following:
a. An allogeneic SCT within 6 months before the first dose of study treatment. Participants who received an allogeneic transplant must be off all immunosuppressive medications during the 6 weeks before the start of study treatment administration without signs of graft-versus-host disease.
b. An autologous SCT within 12 weeks before the start of study treatment administration.
7. Active central nervous system (CNS) involvement or exhibition of clinical signs of meningeal involvement of multiple myeloma. If either is suspected, brain magnetic resonance imaging (MRI) and lumbar cytology are required.
8. Active plasma cell leukemia (>2.0×10^9/L plasma cells by standard differential), Waldenström’s macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, M-protein, and skin changes), or primary amyloid light chain amyloidosis.
9. Known to be seropositive for human immunodeficiency virus.
10. Seropositive for HBV, defined by a positive test for hepatitis B surface antigen (HBsAg). Participants with resolved infection (ie, participants who are HBsAg negative but positive for hepatitis B core antibody [anti-HBc] and/or positive for hepatitis B surface antibody [anti-HBs]) must be screened using real-time polymerase chain reaction (PCR) measurement of HBV deoxyribonucleic acid (DNA) levels. Those who are PCR positive will be excluded. EXCEPTION: Participants with serologic findings suggestive of HBV vaccination (anti-HBs positivity as the only serologic marker) and a known history of prior HBV vaccination do not need to be tested for HBV DNA by PCR.
11. 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.
12. Known allergies, hypersensitivity, or intolerance to any study treatment or their excipients.
13. Any serious underlying medical condition, such as:
a. Evidence of serious active viral, bacterial, or uncontrolled systemic fungal infection.
b. Active autoimmune disease or a documented history of autoimmune disease, with the exception
of vitiligo, resolved childhood atopic dermatitis, and prior Graves’ disease that is currently euthyroid based on clinical symptoms and laboratory testing.
c. Disabling psychiatric conditions (eg, ongoing alcohol or drug abuse), severe dementia, or altered mental status.
d. Any other issue that would impair the ability of the participant to receive, absorb, or tolerate the planned treatment at the study 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 well-being) or that could prevent, limit, or confound the protocol-specified assessments.
14. History of stroke or seizure within 6 months prior to the first dose of study treatment.
15. Any of the following cardiac conditions:
a. New York Heart Association (NYHA) stage III or IV congestive heart failure.
b. Myocardial infarction, unstable angina, or coronary artery bypass graft ≤6 months prior to enrollment.
c. History of clinically significant ventricular arrhythmia or unexplained syncope not believed to be vasovagal in nature or due to dehydration.
d. History of severe nonischemic cardiomyopathy.
For full exclusion criteria, refer to the study protocol.