A Randomized, Open-Label, Multicenter Phase III Clinical Trial to Evaluate the Efficacy and Safety of TQB2934 Injection Versus Investigator-Selected Regimens in Patients With Relapsed/Refractory Multiple Myeloma

Official Summary

This study is a randomized, open-label, multicenter Phase III clinical trial involving patients with relapsed/refractory multiple myeloma. The estimated total sample size is 260 cases, who will be randomly assigned in a 1:1 ratio to the test group and the control group. The primary objective of the study is to demonstrate the efficacy of TQB2934 for injection compared to the investigator-selected regimen in subjects with relapsed or refractory multiple myeloma (RRMM) by evaluating progression-free survival (PFS).

Eligibility Requirements

• Minimum Age: 18 Years
• Maximum Age: 75 Years

Study Design

• Study Type: INTERVENTIONAL
• Allocation: RANDOMIZED
• Model: PARALLEL
• Masking: NONE
• Enrollment: 260 participants

Study Arms

• TQB2934 injection (EXPERIMENTAL)
  TQB2934 injection, 28 days as a treatment cycle.
• Selinexor and Dexamethasone or Pomalidomide Dexamethasone (ACTIVE_COMPARATOR)
  Selinexor and Dexamethasone, 28 days as a treatment cycle or Pomalidomide Dexamethasone, 28 days as a treatment cycle

Interventions

• DRUG: TQB2934 injection — TQB2934 injection is a bispecific antibody targeting B-cell maturation antigen (BCMA) and Cluster of Differentiation 3 (CD3).
• DRUG: Pomalidomide Capsule — Pomalidomide capsules are an immunomodulatory(IMiD).
• DRUG: Selinexor tablets — Selinexor is a selective nuclear export protein inhibitor.
• DRUG: Dexamethasone tablets — Dexamethasone tablets are a type of adrenocortical hormone drug.

Primary Outcomes

• Progression-free survival (PFS) (Baseline up to 5 years)

Secondary Outcomes

• Investigator-assessed PFS (Baseline up to 5 years)
• PFS rates at 6, 12 and 18 months (From baseline to 18 months)
• Overall response rate (ORR) (Baseline up to 5 years)
• Very Good Partial Response (VGPR) (Baseline up to 5 years)
• Complete Response (CR) Rate (Baseline up to 5 years)

Eligibility Criteria

Inclusion Criteria:

* Voluntarily join this study, sign the Informed Consent Form (ICF), and demonstrate good compliance.
* Aged 18 to 75 years old (as of the date of signing the ICF); gender not limited; Eastern Cooperative Oncology Group Performance Status (ECOG) of 0-2.
* Expected survival greater than 3 months.
* Patients with relapsed or refractory multiple myeloma.
* During or after the most recent treatment, there is evidence of disease progression or failure to achieve remission after the last line of treatment。
* Measurable disease at screening.
* Adequate organ function as indicated by laboratory tests meeting the criteria.
* Women of childbearing potential must agree to use effective contraception during the study and for 12 months after the last dose of study treatment, and agree not to donate eggs for reproduction during this period. Must not be breastfeeding and must have a negative serum or urine pregnancy test within 7 days prior to enrollment. Men who have not had a vasectomy and their female partners of childbearing potential should also agree to use effective contraception during the study and for 12 months after the last dose of study treatment, and agree not to donate sperm during this period.

Exclusion Criteria:

* History of other malignancies within 5 years prior to informed consent or concurrent presence of other malignancies. The following exceptions are allowed: other malignancies cured by surgery alone with a disease-free survival (DFS) ≥5 years; cured carcinoma in situ of the cervix, non-melanoma skin cancer, and superficial bladder tumors \[Ta (non-invasive tumor), Tis (carcinoma in situ), and T1 (tumor invading the basement membrane)\].
* Diagnosis of plasma cell leukemia (defined as circulating plasma cells ≥5% in peripheral blood according to standard classification), Waldenström macroglobulinemia, primary light-chain (AL) amyloidosis, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein \[M protein\], and skin changes), or solitary plasmacytoma.
* History of prior anticancer treatment, including but not limited to:

  1. Receipt of chimeric antigen receptor T-cell (CAR-T), Chimeric Antigen Receptor T-Cell Immunotherapy(CAR-T), Chimeric Antigen Receptor Natural Killer Cells (CAR-NK), or other cellular therapies within 3 months prior to randomization;
  2. Receipt of autologous stem cell transplantation within 3 months prior to randomization;
  3. Receipt of allogeneic stem cell transplantation within 6 months prior to randomization; subjects must have discontinued all immunosuppressive therapy for ≥6 weeks and have no signs or symptoms of graft-versus-host disease (GVHD);
  4. Receipt of molecular targeted therapy, investigational drugs, or invasive investigational medical devices within 3 weeks or 5 drug half-lives (whichever is shorter) prior to randomization;
  5. Receipt of monoclonal antibodies, bispecific antibodies, chemotherapy, etc., within 3 weeks prior to randomization;
  6. Receipt of proteasome inhibitors (PI), immunomodulatory drugs (IMiDs), localized radiotherapy, palliative radiotherapy, or Chinese patent medicines with antitumor indications approved by the National Medical Products Administration (NMPA) within 2 weeks prior to randomization.
* Previously refractory to control group drugs, or with contraindications, life-threatening allergic reactions, or intolerance to previous treatments.
* Receipt of systemic corticosteroids at a cumulative dose ≥140 mg prednisone (or equivalent) within 2 weeks prior to randomization. Topical, ophthalmic, intra-articular, intranasal, and inhaled corticosteroids are excluded from the cumulative dose calculation (see Appendix for dose conversion).
* Toxicities from prior antitumor therapy have not recovered to baseline or ≤ Grade 1, except for Grade 2 alopecia, non-clinically significant and asymptomatic laboratory abnormalities, and hypothyroidism stabilized by hormone replacement therapy, as judged by the investigator to pose no safety risk.
* History of Grade ≥3 cytokine release syndrome (CRS) associated with any T-cell redirecting therapy (e.g., CD3-redirecting therapies or CAR-T cell therapy).
* Presence of conditions affecting intravenous infusion or blood collection, dysphagia, chronic diarrhea, intestinal obstruction, or other active gastrointestinal dysfunction that may interfere with drug administration or absorption.
* Known central nervous system (CNS) involvement of multiple myeloma (MM), or clinical signs/symptoms suggestive of leptomeningeal involvement. If either is suspected, both brain MRI and lumbar puncture cytology must be negative.
* Major surgery, significant traumatic injury, or planned major surgery during the study treatment period within 4 weeks prior to randomization, or presence of non-healed wounds or fractures (major surgery defined as Grade ≥3 according to the 2022 national surgical classification catalogue).
* Any severe (≥ CTCAE Grade 3) bleeding or hemorrhagic 

Trial Locations

• The First Affiliated Hospital of Bengbu Medical University, Bengbu, Anhui, China
• The First Affiliated Hospital of Anhui Medical University, Hefei, Anhui, China
• Beijing Chao-Yang Hospital,Capital Medical University, Beijing, Beijing Municipality, China
• Beijing Jishuitan Hospital,Capital Medical University, Beijing, Beijing Municipality, China
• The First Affiliated Hospital of Chongqing Medical University, Chongqing, Chongqing Municipality, China
• The Southwest Hospital of Amu, Chongqing, Chongqing Municipality, China
• Gansu Provincial Maternal and Child Health Hospital (Gansu Provincial Central Hospital), Lanzhou, Gansu, China
• Lanzhou University Second Hospital, Lanzhou, Gansu, China
• Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, Guangdong, China
• Sun Yat-Sen University Cancer Center, Guangzhou, Guangdong, China
• ...and 10 more locations

Contact Information

• Peng Liu, Doctor — CONTACT
  Phone: 18286006744
  Email: liu.peng@zs-hospital.sh.cn

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