To Evaluate the Efficacy and Safety of QL2109 and DARZALEX FASPRO® in Multiple Myeloma

Phase 3

Not yet recruiting

• Conditions: Multiple Myeloma
• Interventions: Drug: QL2109; Drug: Pomalidomide; Drug: Dexamethasone; Drug: DARZALEX FASPRO®

• Registration Number: NCT06742138
• Lead Sponsor: Qilu Pharmaceutical Co., Ltd.

Brief Summary

This is a randomized, double-blind, multicenter trial，parallel control designed to evaluate treatment with pomalidomide + QL2109 + dexamethasone compared with pomalidomide + DARZALEX FASPRO® + dexamethasone in the participants with relapsed or refractory Multiple Myeloma.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-16
• Study First Submitted QC: 2024-12-18
• Last Update Submitted: 2024-12-18
• Study First Posted: 2024-12-19
• Last Update Posted: 2024-12-19
• Study Start: 2025-01
• Primary Completion: 2027-12
• Study Completion: 2028-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 284

Inclusion Criteria

• Males and females at least 18 years of age.

• Subject must have measurable disease of MM as defined by the criteria below:Serum M-protein level ≥0.5 g/dL or urine M-protein level ≥200 mg/24 hours; or Light chain multiple myeloma, for subjects without measurable disease in the serum or urine: Serum immunoglobulin free light chain (FLC) ≥10 mg/dL and abnormal serum immunoglobulin kappa lambda FLC ratio.

• Subjects must have received prior antimyeloma treatment. The prior treatment must have included both a PI- and lenalidomide-containing regimens. Subjects who received only 1 line of prior treatment must have demonstrated PD on or within 60 days of completion of the lenalidomide containing regimen (ie, lenalidomide refractory).

• Subjects must have documented evidence of PD based on the investigator's determination of response as defined by the modified IMWG criteria on or after the last regimen.

• Eastern Cooperative Oncology Group (ECOG) performance status score of ≤ 2.

• For subjects experiencing toxicities resulting from previous therapy, the toxicities must be resolved or stabilized to ≤Grade 1.

• Any of the following laboratory test results during Screening:

  1. Absolute neutrophil count ≥1.0 × 109/L;
  2. Hemoglobin level ≥75 g/L (≥4.65 mmol/L); (transfusions are not permitted to reach this level);
  3. Platelet count ≥75 × 109/L in subjects in whom <50% of bone marrow nucleated cells are plasma cells and platelet count ≥50 x 109/L in subjects in whom ≥50% of bone marrow nucleated cells are plasma cells;
  4. Alanine aminotransferase (ALT) level ≤2.5 times the upper limit of normal (ULN);Aspartate aminotransferase (AST) level ≤2.5 x ULN;
  5. Total bilirubin level ≤1.5 x ULN, (except for Gilbert Syndrome: direct bilirubin ≤1.5 × ULN);
  6. Creatinine clearance ≥30 mL/min
  7. Serum calcium corrected for albumin ≤14.0 mg/dL (≤3.5 mmol/L), or free ionized calcium ≤ 6.5 mg/dL (≤1.6 mmol/L).

Exclusion Criteria

• Subject has plasma cell leukemia (>2.0 × 109/L circulating plasma cells by standard differential) or Waldenström's macroglobulinemia or POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes) or amyloidosis.
• History of malignancy (other than MM) within 3 years before the date of randomization (exceptions are squamous and basal cell carcinomas of the skin, carcinoma in situ of the cervix or breast, or other non-invasive lesion that in the opinion of the investigator, with concurrence with the sponsor's medical monitor, is considered cured with minimal risk of recurrence within 3 years).
• Clinical signs of meningeal involvement of MM.
• Previous therapy with any anti-CD38 monoclonal antibody.
• Previous exposure to pomalidomide.
• Subject has received antimyeloma treatment within 2 weeks or 5 pharmacokinetic half-lives of the treatment, whichever is longer, before the date of randomization. The only exception is emergency use of a short course of corticosteroids (equivalent of dexamethasone 40 mg/day for a maximum of 4 days) for palliative treatment before Cycle 1, Day 1 (C1D1).
• Previous allogenic stem cell transplant; or autologous stem cell transplantation (ASCT) within 12 weeks before C1D1.
• Subject has had major surgery within 2 weeks before randomization, or has not fully recovered from an earlier surgery, or has surgery planned during the time the subject is expected to participate in the study or within 2 weeks after the last dose of study drug administration.
• Ongoing ≥ Grade 2 peripheral neuropathy.
• Subject had ≥Grade 3 rash during prior therapy.
• Pregnant or nursing women.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pomalidomide Plus(+) QL2109 + Dexamethasone	QL2109	-
Pomalidomide Plus(+) QL2109 + Dexamethasone	Pomalidomide	-
Pomalidomide + DARZALEX FASPRO® + Dexamethasone	Dexamethasone	-
Pomalidomide + DARZALEX FASPRO® + Dexamethasone	DARZALEX FASPRO®	-
Pomalidomide Plus(+) QL2109 + Dexamethasone	Dexamethasone	-
Pomalidomide + DARZALEX FASPRO® + Dexamethasone	Pomalidomide	-

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Very Good Partial Response (VGPR) or Better	from baseline to week 24	VGPR or better rate was defined as the percentage of participants who achieved VGPR or complete response (CR) (including stringent complete response\[sCR\]) according to the IMWG criteria during or after the study treatment.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With Very Good Partial Response (VGPR) or Better	from baseline to week 12 and week 48	VGPR or better rate was defined as the percentage of participants who achieved VGPR or complete response (CR) (including stringent complete response\[sCR\]) according to the IMWG criteria during or after the study treatment.
Overall Response Rate	from baseline to week 24 and week 48	Overall response rate is defined as the percentage of randomized subjects who achieve a best response of PR or better using modified IMWG criteria as their best overall response
Overall survival at 18 months	from baseline to 18 months	the probability of being alive 18 months after randomization