A Study Comparing Talquetamab Plus Pomalidomide, Talquetamab Plus Teclistamab, and Elotuzumab, Pomalidomide, and Dexamethasone or Pomalidomide, Bortezomib, and Dexamethasone in Participants with Relapsed or Refractory Myeloma who Have Received an Anti-CD38 Antibody and Lenalidomide

JRCT ID: jRCT2031240026

Registered date:12/04/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Relapsed or Refractory Multiple Myeloma
• Date of first enrollment: 29/05/2024
• Target sample size: 795
• Countries of recruitment: Argentina,Japan,Australia,Japan,Austria,Japan,Belgium,Japan,Brazil,Japan,Canada,Japan,China,Japan,Czechia,Japan,Germany,Japan,Denmark,Japan,Spain,Japan,France,Japan,United Kingdom Of Great Britain,Japan,Greece,Japan,Hungary,Japan,India,Japan,Israel,Japan,Italy,Japan,Korea,Republic Of,Japan,Mexico,Japan,Netherlands,Japan,Poland,Japan,Saudi Arabia,Japan,Sweden,Japan,Turkey,Japan,United States Of America,Japan
• Study type: Interventional

Intervention(s)

Arm A: Talquetamab + Pomalidomide (Tal-P)
Experimental
Participants will receive talquetamab as subcutaneous (SC) injections; pomalidomide will be selfadministered as a single dose orally; dexamethasone may be given orally or intravenously as a pretreatment medication and study drug.

Arm B: Talquetamab + Teclistamab (Tal-Tec)
Experimental
Participants will receive teclistamab in combination with talquetamab both as SC injection; dexamethasone may be given orally or intravenously as a pretreatment medication and study drug.

Arm C: Elotuzumab + Pomalidomide + Dexamethasone (EPd) or Pomalidomide + Bortezomib + Dexamethasone (PVd)
Active Comparator
Participants will either receive elotuzumab intravenous (IV) injection in combination with pomalidomide and dexamethasone orally; or pomalidamide orally in combination with bortezomib SC injection and dexamethasone orally as per
investigator choice. Dexamethasone will be administered as a pretreatment medication.

Talquetamab
Talquetamab will be administered as a SC injection.
JNJ-64407564
Talvey

Pomalidomide
Pomalidomide will be administered orally.
Pomalyst
Imnovid

Teclistamab
Teclistamab will be administered as a SC injection.
JNJ-64007957
Tecvayli

Dexamethasone
Dexamethasone will be administered either orally or intravenously.

Outcome(s)

Primary Outcome

Progression Free Survival (PFS)
Up to 6 years 5 months
PFS is defined as the duration from the date of randomization to either progressive disease or death, whichever comes first.

• Secondary Outcome: refer to the attachement

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

- Documented multiple myeloma as defined by the criteria below: (a) multiple myeloma diagnosis according to the international myeloma working group (IMWG) diagnostic criteria (b) measurable disease at screening as assessed by central laboratory, defined by any of the following: (i) serum M-protein level greater than or equal to (>=) 0.5 gram per deciliter (g/dL); or (ii) urine M-protein level >= 200 milligram (mg) per 24 hours; or (iii) light chain multiple myeloma without measurable M-protein in the serum or the urine: serum immunoglobulin (Ig) free light chain (FLC) >= 10 milligrams per deciliter (mg/dL) and abnormal serum Ig kappa lambda FLC ratio
- Relapsed or refractory disease as defined below: a) Relapsed disease is defined as an initial response to prior treatment, followed by confirmed progressive disease (PD) by IMWG criteria greater than (>) 60 days after cessation of treatment. b) Refractory disease is defined as less than (<) 25 percent (%) reduction in M-protein or confirmed PD by IMWG criteria during previous treatment or less than or equal to (<=) 60 days after cessation of treatment
- Documented evidence of PD or failure to achieve a minimal response to the last line of therapy based on investigator's determination of response by IMWG criteria on or after their last regimen
- Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2 at screening and immediately prior to the start of administration of study treatment
- A participant must agree not to be pregnant, breastfeeding, or planning to become pregnant while enrolled in this study or within 6months after the last dose of study treatment

Exclude criteria

- Contraindications or life-threatening allergies, hypersensitivity, or intolerance to any study drug or its excipients
- Stroke, transient ischemic attack, or seizure within 6 months prior to signing informed consent form (ICF)
- Major surgery or had significant traumatic injury within 2 weeks prior to the start of administration of study treatment, or will not have fully recovered from surgery, or has major surgery planned during the time
the participant is expected to be treated in the study or within 2 weeks after administration of the last dose of study treatment
- A maximum cumulative dose of corticosteroids of >=140 mg of prednisone or equivalent within 14-day period before the first dose of study drug
- Known active central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of multiple myeloma. If either is suspected, negative whole brain magnetic resonance imaging (MRI) and lumbar cytology are required

Related Information

• Primary Sponsor: Nishikawa Kazuko
• Secondary ID(s): NCT06208150