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A Open-Label Phase in Participants With Multiple Myeloma

ConditionMultiple Myeloma
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorInnovent Biologics (Suzhou) Co. Ltd.

About this trial

This is an open-label, multi-center phase II study of IBI3003 in combination with anti-CD38 monoclonal antibody in adult subjects with multiple myeloma. This study includes a safety run-in period and 2 cohorts (Cohorts 1 and 2).In the safety run-in period, subjects with measurable relapsed or refractory multiple myeloma who had previously received at least 1 line of systemic anti-myeloma therapy and had a history of dual drug exposure (at least one proteasome inhibitor and one immunomodulatory agent) were enrolled, mainly to evaluate the safety and tolerability of IBI3003 in combination with anti-CD38 monoclonal antibody and to determine the recommended phase 2 dose of IBI3003 in combination with anti-CD38 monoclonal antibody.Cohort 1 mainly enrolls newly diagnosed MM(Multiple myeloma)patients who are ineligible for or refusing ASCT(Autologous Stem Cell Transplantation), and Cohort 2 enrolls newly diagnosed MM patients who are eligible for and willing to undergo ASCT. The 24-week MRD negative rate of IBI3003 in combination with anti-CD38 monoclonal antibody in the participant population is mainly evaluated.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

1. Aged at least 18 years old;

2. Initial diagnosis of multiple myeloma documented according to International Myeloma Working Group (IMWG) diagnostic criteria.Multiple myeloma is defined as clonal bone marrow plasma cells ≥ 10% or biopsy-proven bony or extramedullary plasmacytoma, and any one or more of the following myeloma-defining events: • Evidence of end-organ damage attributable to the underlying plasma cell proliferative disorder, including the following: Hypercalcemia: serum calcium > 0.25 mmol/L (> 1 mg/dL) above the upper limit of normal or corrected serum calcium > 2.75 mmol/L (> 11 mg/dL); renal insufficiency: creatinine clearance < 40 mL/min or serum creatinine > 177 μmol/L (> 2 mg/dL); anemia: hemoglobin value > 2 g/dL below the lower limit of normal or hemoglobin value < 10 g/dL; bone lesions: one or more osteolytic lesions on skeletal radiographs, computed tomography (CT), or positron emission tomography (PET)-CT.

3.Safety run-in stage: Relapsed or refractory measurable multiple myeloma who have previously received ≥ 1 line of anti-myeloma therapy (including treatment with at least one proteasome inhibitor and one immunomodulatory drug), and the participant must be relapsed or refractory to the most recent treatment.Participants previously exposed to anti-CD38 monoclonal antibodies may also be enrolled (a 90-day washout period is required).

4. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.

Disqualifiers

1. All subjects have previously received any treatment targeting BCMA and any treatment targeting GPRC5D.Participants who have received either a BCMA-directed or GPRC5D-directed therapy are allowed.

2. Known active central nervous system (Central Nervous System, CNS) involvement or clinical symptoms of meningeal involvement of multiple myeloma.

3. Has amyloidosis, plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS syndrome, solitary plasmacytoma, or smoldering (asymptomatic) multiple myeloma as defined by IMWG criteria.

4. Patients with spinal cord compression resulting in limited self-care at present or within 6 months before signing the informed consent form, or expected to result in such restrictions during study participation.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Dexamethasone

    Drug

    A potent synthetic glucocorticoid

  • IBI3003

    Biological/Vaccine

    Recombinant humanized anti-GPRC5D/BCMA/CD3 trispecific antibody injection

  • Lenalidomide

    Drug

    An Oral Immunomodulator And Antineoplastic Drug

  • Daratumumab

    Drug

    Anti-cancer monoclonal antibody targeting CD38

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: treatment groupExperimental treatment 2 interventions
Group B: Standard-of-care control groupActive comparator 3 interventions

Trial outcomes

Primary outcomes

1

MRD（ Minimal Residue Disease) negativity rate at 24 weeks

Defined as the percentage of participants who achieved MRD-negative status at or below the threshold of 10-5 at any time after the first treatment.

Time frame
24weeks
2

AE(Adverse event)

Adverse events will be assessed by investigator(s) according to NCI-CTCAE V5.0

Time frame
30Days
3

TEAE(Treatment emergent adverse event)

Adverse events will be assessed by investigator(s) according to NCI-CTCAE V5.0

Time frame
30Days
4

SAE（Serious Adverse Event）

Adverse events will be assessed by investigator(s) according to NCI-CTCAE V5.0

Time frame
30Days

Secondary outcomes

1

Progression-Free Survival (PFS)

FPS is defined as the time from the date of randomization to the date of the first documented progression or death due to any case ,whichever occurs first

Time frame
3years
2

ORR(objective response rate)

Defined as the proportion of participants achieving sCR, CR, VGPR, or PR according to the IMWG criteria

Time frame
3years
3

AE(Adverse event)

Adverse events will be assessed by investigator(s) according to NCI-CTCAE V5.0

Time frame
12Months
4

TEAE(Treatment emergent adverse event)

Adverse events will be assessed by investigator(s) according to NCI-CTCAE V5.0

Time frame
12Months

Other outcomes

Sponsors and contacts

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

Innovent Biologics (Suzhou) Co. Ltd.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: