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A Clinical Study Comparing SG301 Plus Pomalidomide and Dexamethasone to Placebo Plus Pomalidomide and Dexamethasone in Relapsed or Refractory Multiple Myeloma Patients

ConditionRelapsed/Refractory Multiple Myeloma
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorHangzhou Sumgen Biotech Co., Ltd.

About this trial

The purpose of this study is to evaluate the effects of the addition of SG301 injection to pomalidomide and dexamethasone in subjects with relapsed or refractory multiple myeloma.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Understand and voluntarily sign the informed consent form (ICF).

Males and females aged 18-75 years (inclusive)

Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0, 1 or 2

Expected survival time of ≥3 months.

Disqualifiers

Primary refractory multiple myeloma defined as participants who had never achieved at least a minimal response (MR) with any treatment during the disease course.

Bone independent extramedullary disease at screening.

Subjects who are primary refractory to a prior CD38 monoclonal antibody therapy.

Previous exposure to pomalidomide.

Trial design

Design model

Parallel

Treatments tested in this trial

  • SG301 Injection

    Drug

    Dosage form: solution for infusion Route of administration: intravenous Frequency: weekly intervals (QW) for 8 weeks, then every 2 weeks (Q2W) thereafter.

  • SG301 placebo

    Drug

    Dosage form: solution for infusion Route of administration: intravenous Frequency: weekly intervals (QW) for 8 weeks, then every 2 weeks (Q2W) thereafter.

  • pomalidomide

    Drug

    Dosage form: capsule Route of administration: oral Dosage: 4 mg Frequency: once daily on Days 1 through 21 of each 28-day cycle.

  • dexamethasone

    Drug

    Dosage form: tablets or solution for infusion Route of administration: oral or intravenous Dosage: 40 mg (participants with BMI \< 18.5 kg/m2 received 20 mg dexamethasone) Frequency: once daily on Day 1, 8, 15, 22 of each 28-day treatment cycle.

Treatment groups

360 Participants
are divided into 2 treatment groups
Group A: SG301 Injection in combination with pomalidomide and dexamethasoneExperimental treatment 3 interventions
Group B: Placebo in combination with pomalidomide and dexamethasonePlacebo comparator 3 interventions

Trial outcomes

Primary outcomes

1

Adverse events （stage 1）

AEs, DLTs, laboratory abnormality, Vital signs or ECG abnormalities, ECOG scores, abnormal physical examination

Time frame
From date of first dose of study intervention through approximately 30 days after last study intervention administration, assessed up to approximately 4 years.
2

Recommended stage 2 dose of SG301 (Stage 1)

Recommended stage 2 dose of SG301 will be determined based on the DLTs and safety data

Time frame
Up to approximately 6 months.
3

Progression Free Survival (Stage 2)

Comparison of Progression Free Survival between treatment arms (SG301/Pomalidomide/Dexamethasone vs Placebo/Pomalidomide/Dexamethasone).

Time frame
From baseline through the end of study. Assessed every 4 weeks after randomization until C19D1, and every 8 weeks thereafter until disease progression (IMWG criteria) or death whichever occurs first, assessed up to approximately 4 years.

Secondary outcomes

1

Pharmacokinetics (PK): AUC

The area under the curve (AUC) of serum concentration of the drug after the administration.

Time frame
From date of first dose of study intervention through approximately 30 days after last study intervention administration, assessed up to approximately 4 years.
2

Pharmacokinetics (PK): Cmax

Cmax to maximum drug concentration.

Time frame
From date of first dose of study intervention through approximately 30 days after last study intervention administration, assessed up to approximately 4 years.
3

Pharmacokinetics (PK):limination half-life (T1/2)

Limination half-life (T1/2) of the drug after administration.

Time frame
From date of first dose of study intervention through approximately 30 days after last study intervention administration, assessed up to approximately 4 years.
4

Immunogenicity endpoints

Anti-SG301 antibody, neutralizing antibody (to be detected only in case of the presence of anti-SG301 antibody.

Time frame
From date of first dose of study intervention through approximately 30 days after last study intervention administration, assessed up to approximately 4 years.

Other outcomes

Sponsors and contacts

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

Hangzhou Sumgen Biotech Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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