OncoMatch/Clinical Trials/NCT06464991
A Phase III Study of Eque-cel in Subjects With Len-refractory RRMM (FUMANBA-03)
Is NCT06464991 recruiting? Yes, currently enrolling (Jun 2026). This Phase 3 trial studies multiple treatments for multiple myeloma.
Treatment: Equecabtagene Autoleucel · Daratumumab · Pomalidomide · Bortezomib · Dexamethasone — This is a multicenter, randomized, controlled, open-label, phase III clinical study to evaluate the efficacy of Equecabtagene Autoleucel Injection versus standard therapy in subjects with lenalidomid-refractory RRMM who have received 1-2 lines of prior therapy.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Targeted therapy
Endocrine / hormonal
Other
Cancer type
Multiple Myeloma
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
Prior therapy
Must have received: proteasome inhibitor
including chemotherapy regimens based on proteasome inhibitors
Must have received: immunomodulatory agent
including chemotherapy regimens based on...immunomodulatory agents
Must have received: lenalidomide (lenalidomide)
Subjects was lenalidomide-refractory during prior therapy
Cannot have received: autologous hematopoietic stem cell transplantation
Exception: within 12 weeks prior to randomization
Subjects who have undergone autologous haematopoietic stem cell transplantation (Auto-HSCT) within 12 weeks prior to randomization
Cannot have received: allogeneic hematopoietic stem cell transplantation
previously undergone allogeneic haematopoietic stem cell transplantation (Allo-HSCT)
Cannot have received: immunomodulator
Exception: within 7 days prior to enrollment
Treated with an immunomodulator within 7 days
Cannot have received: plasma exchange
Exception: within 14 days prior to enrollment
Received plasma exchange...within 14 days
Cannot have received: radiotherapy
Exception: within 14 days prior to enrollment (except local radiotherapy for myeloma-related bone lesions)
radiotherapy (except local radiotherapy for myeloma-related bone lesions)...within 14 days
Cannot have received: cytotoxic chemotherapy
Exception: within 14 days prior to enrollment
cytotoxic chemotherapy...within 14 days
Cannot have received: proteasome inhibitor
Exception: within 14 days prior to enrollment
treatment with proteasome inhibitors...within 14 days
Cannot have received: investigational drug
Exception: within 14 days prior to enrollment
other investigational drug within 14 days
Cannot have received: monoclonal antibody for multiple myeloma
Exception: within 21 days prior to enrollment
Treatment with monoclonal antibody for multiple myeloma within 21 days
Cannot have received: other anti-cancer therapy
Exception: within 14 days or at least 5 half-lives (whichever is shorter) prior to enrollment
Received other anti-cancer therapy within 14 days or at least 5 half-lives (whichever is shorter) prior to enrollment
Lab requirements
Blood counts
ANC ≥1×10^9/L (no growth factor within 7 days); ALC ≥0.3×10^9/L; Platelets ≥50×10^9/L (no platelet transfusion within 7 days); Hemoglobin ≥60g/L (no RBC transfusion within 7 days)
Kidney function
creatinine clearance (CrCl) ≥ 40 ml/min
Liver function
ALT and AST ≤2.5x ULN; total bilirubin ≤1.5x ULN
Cardiac function
LVEF ≥50%
Subjects must have appropriate organ function and meet all of the following laboratory test results before enrollment: (1) Haematology: absolute neutrophil count (ANC) ≥1×10^9/L (support with growth factor is allowed, but must not have received supportive treatment within 7 days before the laboratory test); Absolute lymphocyte count (ALC) ≥0.3×10^9/L; Platelets ≥50×10^9 / L (must not have received platelet transfusion within 7 days prior to laboratory test); Hemoglobin ≥60g/L (must not have received red blood cells transfusion within 7 days prior to laboratory test); (2) Hepatic function: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 times of upper limit of normal (ULN); Serum total bilirubin ≤1.5 times of ULN; (3) Renal function: creatinine clearance (CrCl) calculated by Cockcroft-Gault formula ≥ 40 ml/min; (4) Coagulation: fibrinogen≥1.0 g/L; activated partial thromboplastin time (APTT) ≤ 1.5×ULN, pro-thrombin time (PT) ≤ 1.5 × ULN; (5) Pulse oxygen saturation > 91%; (6) Left ventricular ejection fraction (LVEF)≥50%;
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT06464991 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior autologous hematopoietic stem cell transplantation, allogeneic hematopoietic stem cell transplantation, immunomodulator disqualifies patients from enrollment.
Is there an age limit?
Yes. Patients must be 75 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages