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

NCT06742138 | Not Yet Recruiting Phase 3

• 1 other identifier: QL2109-301
• Study Type: interventional
• Target: 284
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Very Good Partial Response (VGPR) or Better

  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.

  from baseline to week 24

Secondary Outcomes (3)

• Percentage of Participants With Very Good Partial Response (VGPR) or Better

  from baseline to week 12 and week 48

• Overall Response Rate

  from baseline to week 24 and week 48

• Overall survival at 18 months

  from baseline to 18 months

Study Arms (2)

Pomalidomide Plus(+) QL2109 + Dexamethasone

EXPERIMENTAL

Drug: QL2109; Drug: Pomalidomide; Drug: Dexamethasone

Pomalidomide + DARZALEX FASPRO® + Dexamethasone

ACTIVE COMPARATOR

Drug: Pomalidomide; Drug: Dexamethasone; Drug: DARZALEX FASPRO®

Interventions

QL2109 DRUG

QL2109 will be given 1800 mg subcutaneously at weekly intervals (QW) for 8 weeks, then every 2 weeks (Q2W) for an additional 16 weeks, then every 4 weeks (Q4W) thereafter. Subjects will receive pre-infusion medications before infusions to mitigate potential IRRs.

Pomalidomide Plus(+) QL2109 + Dexamethasone

Pomalidomide DRUG

Intervention Description：Pomalidomide will be administered at full dose of 4 mg orally (PO) on Days 1 through 21 of each 28-day cycle

Pomalidomide + DARZALEX FASPRO® + Dexamethasone; Pomalidomide Plus(+) QL2109 + Dexamethasone

Dexamethasone DRUG

Dexamethasone will be administered at a dose of 40 mg (20 mg for patients ≥75 years of age) orally, once daily on Days 1, 8, 15, and 22 of each 28-day treatment cycle

Pomalidomide + DARZALEX FASPRO® + Dexamethasone; Pomalidomide Plus(+) QL2109 + Dexamethasone

DARZALEX FASPRO® DRUG

DARZALEX FASPRO® will be given 1800 mg subcutaneously at weekly intervals (QW) for 8 weeks, then every 2 weeks (Q2W) for an additional 16 weeks, then every 4 weeks (Q4W) thereafter. Subjects will receive pre-infusion medications before infusions to mitigate potential IRRs

Pomalidomide + DARZALEX FASPRO® + Dexamethasone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Absolute neutrophil count ≥1.0 × 109/L;
• Hemoglobin level ≥75 g/L (≥4.65 mmol/L); (transfusions are not permitted to reach this level);
• 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;
• Alanine aminotransferase (ALT) level ≤2.5 times the upper limit of normal (ULN);Aspartate aminotransferase (AST) level ≤2.5 x ULN;
• Total bilirubin level ≤1.5 x ULN, (except for Gilbert Syndrome: direct bilirubin ≤1.5 × ULN);
• Creatinine clearance ≥30 mL/min
• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Qilu Pharmaceutical Co., Ltd.: lead

MeSH Terms

Conditions

Multiple Myeloma

Interventions

pomalidomide; Dexamethasone

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Central Study Contacts

zhen cai, Professor

CONTACT

+086-0571-87236560; caizhen1@sina.com

baijun fang, Professor

CONTACT

+086-0371-65587418; fdation@126.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2024
• First Posted: December 19, 2024
• Study Start: January 1, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: December 19, 2024

Record last verified: 2024-12