A Randomized Study Comparing Bortezomib, Lenalidomide and Dexamethasone (VRd) followed by Ciltacabtagene Autoleucel versus Bortezomib, Lenalidomide, and Dexamethasone (VRd) followed by Lenalidomide and Dexamethasone (Rd) Therapy in Participants with Newly Diagnosed Multiple Myeloma for Whom Stem Cell Transplant is Not Planned as Initial Therapy

Phase 1

• Conditions: Multiple Myeloma; Therapeutic area: Diseases [C] - Neoplasms [C04]

• Registration Number: CTIS2023-505850-16-00
• Lead Sponsor: Janssen - Cilag International

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-03-05
• Last Update Posted: 21 August 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 621

Inclusion Criteria

1. =18 years of age, 2. Documented diagnosis of MM according to IMWG diagnostic criteria, 3. Measurable disease at Screening, 4. Not considered for high-dose chemotherapy with autologous stem cell transplant (ASCT), 5. Eastern Cooperative Oncology Group Performance Status grade of 0 or 1 Contraceptive/Barrier Requirements, 6. A woman of childbearing potential (WOCBP) must have 2 negative highly sensitive serum or urine pregnancy test (beta-human chorionic gonadotropin) tests prior to starting VRd and must agree to further testing during the study., 7. When a woman is of childbearing potential, the participant must commit either to abstaining continuously from heterosexual intercourse or agree to practice 2 methods of reliable birth control simultaneously, ie, one highly effective method of contraception (failure rate of <1% per year when used consistently and correctly; see examples below) and one other effective method (ie, male latex or synthetic condom, diaphragm, or cervical cap)., 8. A man must commit either to abstaining continuously from heterosexual intercourse or a man • Who is sexually active with a WOCBP or a pregnant woman must agree to use a barrier method of contraception (eg, latex or synthetic condom with spermicidal foam/gel/film/cream/suppository), without interruption, from the time of signing the informed consent form (ICF) until at least 4 weeks after the last dose of lenalidomide, 3 months after the last dose of bortezomib, 1 year after receiving the conditioning regimen (cyclophosphamide and fludarabine) or 1 year after receiving cilta-cel infusion (whichever is later), even if they have undergone a successful vasectomy. • Should agree to practice contraception according to and for the time frame specified in the global REVLIMID® ( or generic lenalidomide) pregnancy prevention program or equivalent local REVLIMID® (or generic lenalidomide) pregnancy prevention program, whichever is more stringent., 9. Women and men must agree not to donate eggs (ova, oocytes) or sperm, respectively, during the study and until at least 4 weeks after the last dose of lenalidomide, 3 months after the last dose of bortezomib, 1 year after receiving the conditioning regimen (cyclophosphamide and fludarabine), or 1 year after receiving cilta-cel infusion (whichever is later).

Exclusion Criteria

1. Frailty index of = 2 according to Myeloma Geriatric Assessment score, 10. Hepatitis B infection. In the event the infection status is unclear, quantitative levels are necessary to determine the infection status., 11. Hepatitis C infection (defined as anti-hepatitis C virus [HCV] antibody positive or detectable HCV-RNA) or known to have a history of hepatitis C., 12. Participant must not require continuous supplemental oxygen., 13. Contraindications, known life-threatening allergies, hypersensitivity, or intolerance to any of the study treatments, including cyclophosphamide or fludarabine (if known) or any of their excipients, including boron, mannitol, dimethyl sulfoxide., 14. Serious underlying medical condition, such as: • Evidence of active viral or bacterial infection requiring systemic antimicrobial therapy, or uncontrolled systemic fungal infection • Active autoimmune disease • Overt clinical evidence of dementia or altered mental status • Any history of Parkinson's disease or other neurodegenerative disorder Prior/Concomitant Medications., 15. Prior treatment with CAR-T therapy directed at any target., 16. Any therapy that is targeted to BCMA., 17. Any prior therapy for MM or smoldering myeloma other than a short course of corticosteroids and/or maximum 1 cycle of VRd therapy prior to enrollment. •Radiation therapy for treatment of plasmacytoma within 14 days before enrollment (palliative radiation for pain control secondary to lytic lesion is allowed within 14 days of enrollment). However, if the radiation portal covered =5% of the bone marrow reserve, the subject is eligible irrespective of the end date of radiation therapy., 2. Active malignancies (ie, progressing or requiring treatment change in the last 24 months) other than the disease being treated under study., 3.Peripheral neuropathy or neuropathic pain Grade 2 or higher, as defined by the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5., 4. The following cardiac conditions: • New York Heart Association Stage III or IV congestive heart failure • Myocardial infarction or coronary artery bypass graft =6 months prior to enrollment • History of clinically significant ventricular arrhythmia or unexplained syncope, not believed to be vasovagal in nature or due to dehydration • History of severe non-ischemic cardiomyopathy • Screening 12-lead ECG showing a baseline corrected Prolonged corrected QT interval (QTc) >470 msec (for women) and >450 msec (for men), as assessed by 12-lead ECG, except in participants with a pacemaker. • Impaired cardiac function (left ventricular ejection fraction <45%) as assessed by echocardiogram or multiple-gated acquisition (MUGA) scan., 5. Known active, or prior history of central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of MM., 6.Stroke or seizure within 6 months of signing ICF., 7.Plasma cell leukemia at the time of screening (>2.0 x 10^9/L plasma cells by standard differential), Waldenström's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), or primary amyloid light-chain amyloidosis., 8. Seropositive for human immunodeficiency virus (HIV)., 9. Vaccinated with live, attenuated vaccine within 4 weeks prior to first dose of VRd.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified