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Protocol Number79635322MMY3002
NCT Number(ClinicalTrials.gov Identfier)NCT07518186
Active

2026-05-01 - 2033-12-31

Phase III

Recruiting6

A Phase 3 Randomized Study Comparing JNJ-79635322 Versus Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma After 1 to 3 Prior Lines of Therapy, Including an Anti-CD38 Antibody and Lenalidomide

  • Trial Applicant

    Johnson & Johnson

  • Sponsor

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/09/10

Investigators and Locations

Principal Investigator Shang-Yi Huang Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 王銘崇 Division of Hematology & Oncology
Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 滕傑林 Division of Hematology & Oncology
Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Su-Peng Yeh Division of Hematology & Oncology
China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chia-Jen Liu Division of Hematology & Oncology
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Tsai-Yun Chen
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Multiple Myeloma

Objectives

在先前曾接受 1 至 3 線療法（其中包括抗 CD38 抗體和 lenalidomide）的 RRMM 參與者中，依據完全緩解 (CR) 或更佳及 PFS 的雙主要指標，比較 JNJ-79635322 與 teclistamab 的療效。

Test Drug

皮下注射劑
皮下注射劑

Active Ingredient

JNJ-79635322
Teclistamab

Dosage Form

220
220

Dosage

5 mg/1 ml
30 mg/3 ml

Endpoints

根據國際骨髓瘤工作組 (IMWG) 反應標準進行下列療效評估：
1.完全反應 (CR) 或更佳反應率，定義為在試驗治療期間或之後，且在下一線抗骨髓瘤治療之前，根據 IMWG 反應標準達到 CR 或sCR的參與者百分比。
2.無惡化存活期 (PFS)，定義為從隨機分配當天開始，到疾病惡化或死亡（以先發生者為準）所經過的時間。

Inclution Criteria

Inclusion criteria:

Documented diagnosis of multiple myeloma (MM) as defined by the criteria below: a. MM diagnosis according to the international myeloma working group (IMWG) diagnostic criteria, b. Measurable disease at screening as assessed by central laboratory
Received 1 to 3 prior lines of antimyeloma therapy, including an anti-cluster of differentiation (CD) 38 antibody and lenalidomide
Have an eastern cooperative oncology group (ECOG) performance status of 0 to 2 at screening and immediately before the first dose of study medication
Have clinical laboratory values meeting the criteria specified in the protocol during the screening and within 1 day of the start of administration of study treatment

Exclusion Criteria

Exclusion criteria:

Major surgery, (for example, requiring general anesthesia) or significant traumatic injury within 2 weeks prior to first dose, or will not have fully recovered from surgery, or has surgery planned during the time the participant is expected to participate in the study
Suspected or known allergies, hypersensitivity, intolerance or other contraindications to the use of JNJ-79635322 or teclistamab or their excipients
Presence of any of the following: i. Any ongoing myelodysplastic syndrome or B-cell malignancy (other than MM); ii. Any history of malignancy, other than MM, that is considered at high risk of recurrence requiring systemic therapy; iii. Any active malignancy (that is, progressing or requiring treatment change in the last 24 months) other than MM
Known active or prior central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of MM. If either is suspected, negative whole brain magnetic resonance imaging (MRI) and lumbar cytology are required

The Estimated Number of Participants

  • Taiwan

    30 participants

  • Global

    700 participants

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