Trial Title:
A Clinical Study Comparing SG301 Plus Pomalidomide and Dexamethasone to Placebo Plus Pomalidomide and Dexamethasone in Relapsed or Refractory Multiple Myeloma Patients
NCT ID:
NCT06508983
Condition:
Relapsed/Refractory Multiple Myeloma
Conditions: Official terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Dexamethasone
Pomalidomide
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
This Study consists of Stage 1 and Stage 2.
Stage 1 ：Single group. Subjects will receive SG301 Injection in combination with
pomalidomide and dexamethasone.
Stage 2：Parallel. Subjects will be randomized to receive SG301 Injection in combination
with pomalidomide and dexamethasone or placebo in combination with pomalidomide and
dexamethasone.
Primary purpose:
Treatment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description:
Stage 1#Open-label Stage 2#Double-blind
Intervention:
Intervention type:
Drug
Intervention name:
SG301 Injection
Description:
Dosage form: solution for infusion Route of administration: intravenous Frequency: weekly
intervals (QW) for 8 weeks, then every 2 weeks (Q2W) thereafter.
Arm group label:
SG301 Injection in combination with pomalidomide and dexamethasone
Intervention type:
Drug
Intervention name:
SG301 placebo
Description:
Dosage form: solution for infusion Route of administration: intravenous Frequency: weekly
intervals (QW) for 8 weeks, then every 2 weeks (Q2W) thereafter.
Arm group label:
Placebo in combination with pomalidomide and dexamethasone
Intervention type:
Drug
Intervention name:
pomalidomide
Description:
Dosage form: capsule Route of administration: oral Dosage: 4 mg Frequency: once daily on
Days 1 through 21 of each 28-day cycle.
Arm group label:
Placebo in combination with pomalidomide and dexamethasone
Arm group label:
SG301 Injection in combination with pomalidomide and dexamethasone
Intervention type:
Drug
Intervention name:
dexamethasone
Description:
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.
Arm group label:
Placebo in combination with pomalidomide and dexamethasone
Arm group label:
SG301 Injection in combination with pomalidomide and dexamethasone
Summary:
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.
Detailed description:
This is a randomized, placebo-controlled, double-blind, multicenter phase III clinical
study to compare SG301 injection in combination with pomalidomide and dexamethasone
versus placebo in combination with pomalidomide and dexamethasone in patients with
relapsed or refractory multiple myeloma who have received at least 1 prior treatment
regimen with both lenalidomide and a proteasome inhibitor and have demonstrated disease
progression.
This study consists of two stages. Stage 1 is the dose exploration stage to confirm the
recommended stage 2 dose of SG301 injection in combination with pomalidomide and
dexamethasone in patients with relapsed/refractory multiple myeloma. Stage 2 is the
randomized controlled stage of SG301 injection in combination with pomalidomide and
dexamethasone versus placebo in combination with pomalidomide and dexamethasone in
patients with relapsed/refractory multiple myeloma.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Understand and voluntarily sign the informed consent form (ICF).
2. Males and females aged 18-75 years (inclusive)
3. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0, 1 or 2
4. Expected survival time of ≥3 months.
5. Subjects had a documented diagnosis of multiple myeloma with evidence of measurable
disease.
6. Subjects had received at least 1 prior lines of anti-myeloma therapy, which must
include lenalidomide and a proteasome inhibitor (bortezomib, carfilzomib or
ixazomib) given alone or in combination.
7. Subjects must have documented evidence of PD on or after the last regimen.
8. Adequate function of vital organs
9. Women of childbearing potential (WOCBP) must agree to follow instructions for
methods of contraception for 4 weeks before the start of study treatment, for the
duration of study treatment, and for 6 months after cessation of SG301 or 4 weeks
after cessation of pomalidomide, whichever is longer. WOCBP must have 2 negative
serum or urine pregnancy tests, one 10-14 days prior to start of study treatment and
one 24 hours prior to the start of study treatment.
Exclusion Criteria:
1. Primary refractory multiple myeloma defined as participants who had never achieved
at least a minimal response (MR) with any treatment during the disease course.
2. Bone independent extramedullary disease at screening.
3. Subjects who are primary refractory to a prior CD38 monoclonal antibody therapy.
4. Previous exposure to pomalidomide.
5. Subject has received chemotherapy or small molecule antitumor therapy within 2 weeks
or 5 pharmacokinetic half-lives of the treatment, whichever is shorter, before the
first dose of study treatment;
6. Subject has received tumor biotherapy within 4 weeks or 5 pharmacokinetic half-lives
of the treatment, whichever is shorter, before the first dose of study treatment;
7. Subject has received investigational agents within 4 weeks or 5 pharmacokinetic
half-lives of the treatment, whichever is shorter (but not less than 14 days),
before the first dose of study treatment;
8. Active hepatitis B, or C.
9. Known HIV infection.
10. Known active tuberculosis or positive treponema pallidum antibodies.
11. Subjects with clinical significant organ dysfunction that does not meet the study
needs.
12. Previous allogenic stem cell transplant or autologous stem cell transplantation
(ASCT) before the first dose of study treatment.
13. Known allergy to any component of the investigational medicinal product.
14. Any concurrent medical or psychiatric condition or disease (eg, active systemic
infection, uncontrolled diabetes, acute diffuse infiltrative pulmonary disease) that
is likely to interfere with the study procedures or results or that, in the opinion
of the investigator, would constitute a hazard for participating in this study.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Beijing Chaoyang Hospital of Capital Medical University
Address:
City:
Beijing
Zip:
100024
Country:
China
Status:
Recruiting
Contact:
Last name:
Wenming Chen, Doctor
Contact backup:
Last name:
Ying Tian
Facility:
Name:
Guangzhou First People's Hospital
Address:
City:
Guangzhou
Zip:
510000
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Shunqing Wang
Contact backup:
Last name:
Wei Zhou
Facility:
Name:
Sun Yat-sen University Cancer Center
Address:
City:
Guangzhou
Zip:
510000
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Zhongjun Xia
Contact backup:
Last name:
Xiaoqin Chen
Facility:
Name:
First Affiliated Hospital of Henan University of Science and Technology
Address:
City:
Luoyang
Zip:
471000
Country:
China
Status:
Recruiting
Contact:
Last name:
Haiping Yang
Contact backup:
Last name:
Bingke Zhu
Facility:
Name:
Henan Cancer Hospital
Address:
City:
Zhengzhou
Zip:
450000
Country:
China
Status:
Recruiting
Contact:
Last name:
Baijun Fang
Contact backup:
Last name:
Yuzhang Liu
Facility:
Name:
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Address:
City:
Wuhan
Zip:
430000
Country:
China
Status:
Recruiting
Contact:
Last name:
Chunyan Sun
Contact backup:
Last name:
Fei Zhao
Facility:
Name:
The First Affiliated Hospital Of Soochow University
Address:
City:
Suzhou
Zip:
215006
Country:
China
Status:
Recruiting
Contact:
Last name:
ZhengZheng Fu
Contact backup:
Last name:
Yingying Zhai
Facility:
Name:
Shanxi Provincial Hospital
Address:
City:
Taiyuan
Zip:
030000
Country:
China
Status:
Recruiting
Contact:
Last name:
Liping Su
Contact backup:
Last name:
Jingrong Wang
Facility:
Name:
The Second Affiliated Hospital Of Xi an Jiaotong University (Xibei Hospital)
Address:
City:
Xi'an
Zip:
710000
Country:
China
Status:
Recruiting
Contact:
Last name:
Wanhong Zhao
Contact backup:
Last name:
Fangxia Wang
Facility:
Name:
Tianjin Cancer University Airport Hospital
Address:
City:
Tianjin
Zip:
300060
Country:
China
Status:
Recruiting
Contact:
Last name:
Yafei Wang
Contact backup:
Last name:
Zhiying Zhang
Facility:
Name:
Tianjin Medical University Cancer Institute & Hospital
Address:
City:
Tianjin
Zip:
300060
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Yafei Wang
Contact backup:
Last name:
Haifeng Zhao
Facility:
Name:
The Second Affiliated Hospital Zhejiang University School Of Medicine
Address:
City:
Hangzhou
Zip:
310056
Country:
China
Status:
Recruiting
Contact:
Last name:
Wenbin Qian
Contact backup:
Last name:
Xuzhao Zhang
Start date:
June 14, 2024
Completion date:
March 31, 2028
Lead sponsor:
Agency:
Hangzhou Sumgen Biotech Co., Ltd.
Agency class:
Industry
Source:
Hangzhou Sumgen Biotech Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06508983
