Health TrialsbyHealthPanel

Phase II Study of QLS32015 Combination Therapy in the Treatment of Multiple Myeloma

ConditionRelapsed or Refractory Multiple Myeloma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorQilu Pharmaceutical Co., Ltd.

About this trial

The purpose of the study is to compare the efficacy of QLS32105 (SC) in combination with Pomalidomide, and QLS32105 (SC) in combination with QL2109 or Daratumumab, and QLS32105 (SC) in combination with QL2109 or Daratumumab and Pomalidomide, and QLS32105(SC) in combination with Bortezomib and Lenalidomide.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosis of multiple myeloma confirmed according to the 2016 International Myeloma Working Group (IMWG) diagnostic criteria;

Prior therapy: Relapsed, progressed, or intolerant to ≥1 prior line of anti-multiple myeloma therapy;

Serum M-protein ≥1.0 g/dL (10 g/L);

Urine M-protein ≥200 mg/24 hours;

Disqualifiers

History of Grade 3 or higher cytokine release syndrome (CRS) associated with any T-cell redirecting therapy (e.g., CD3-redirecting technologies or CAR-T cell therapy);

Previous treatment with GPRC5D-targeted therapy;

Genetically modified adoptive cell therapy (e.g., chimeric antigen receptor T-cell [CAR-T], natural killer [NK] cell therapy) within 3 months;

Targeted therapy, investigational drugs, or invasive investigational medical devices within 21 days or 5 half-lives (whichever is longer);

Trial design

Design model

Parallel

Treatments tested in this trial

  • QLS32015

    Drug

    QLS32015 will be administered subcutaneously

  • Pomalidomide

    Drug

    Pomalidomide will be self-administered as a single dose orally

  • Dexamethasone

    Drug

    Dexamethasone will be administered orally or intravenously

  • QL2109 or Daratumumab

    Drug

    QL2109 or Daratumumab will be administered subcutaneously.

  • Bortezomib

    Drug

    Bortezomib will be administered subcutaneously

  • Lenalidomide

    Drug

    Lenalidomide will be self-administered as a single dose orally

Treatment groups

160 Participants
are divided into 4 treatment groups
Group A: QLS32015(SC) in combination with PomalidomideExperimental treatment 3 interventions
Group B: QLS32015(SC) in combination with QL2109 or Daratumumab.Experimental treatment 3 interventions
Group C: QLS32015(SC) in combination with QL2109 or Daratumumab and PomalidomideExperimental treatment 4 interventions
Group D: QLS32015(SC) in combination with Bortezomib for injection and LenalidomideExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

ORR (Partial Response [PR] or Better)

Overall response (PR or better) is defined as percentage of participants who have a PR or better per International Myeloma Working Group (IMWG) criteria

Time frame
Up to 2 years
2

Overall Minimal Residual Disease (MRD)

MRD-negative is defined as proportion of participants who achieve MRD negativity at a threshold of 10\^-5 at any timepoint after the first dose of study drug and before disease progression or start of subsequent antimyeloma therapy

Time frame
Up to 2 years

Secondary outcomes

1

Progression-Free Survival (PFS)

PFS is defined as time from the date of randomization to the first documentation of disease progression, or death due to any cause, whichever is reported first

Time frame
Up to 2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Qilu Pharmaceutical Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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