Multiple myeloma
Conditions
Interventions
Case series of RRMM:HXMM-DRD
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Chinese subjects aged >=18 years old; 2. patients diagnosed as RRMM according to IMWG diagnostic criteria; 3. the high-sensitivity serum pregnancy test (beta human chorionic gonadotrophin [beta-hcg]) must be negative for the screening of fertile women; 4. fertile women must comply with the following requirements: subjects must agree to use a highly effective contraceptive method (with an annual failure rate of continuous and correct use < 1%) and agree to continue using a highly effective contraceptive method for at least 100 days from signing the informed consent form (ICF) to receiving the BAD regimen infusion. Effective contraceptive methods include: non-user dependent methods: 1) implantable progesterone contraceptives that inhibit ovulation; 2) intrauterine contraceptive device (IUD); Intrauterine hormone release system; 3) vasectomy of the sexual partner; User dependent methods: 1) compound hormonal contraceptives that inhibit ovulation (including estrogen and progesterone) : oral, vaginal and percutaneous; 2) progesterone contraceptives (oral or injectable) that inhibit ovulation; 5. in addition to highly effective contraceptive methods, male subjects should: agree to use barrier contraception (e.g., condom plus spermicide foam/gel/film/emulsion/suppository) when having sex with a fertile female within at least 100 days from signing ICF to receiving hmm-drd infusion; Use condoms when having sex with a pregnant woman. Women and men must agree not to donate eggs (eggs, oocytes) or sperm during the study and at least 100 days after the BAD infusion. Note: hormonal contraceptives may interact with research treatments to reduce contraceptive effectiveness; 6. subjects must sign ICF indicating that they understand the purpose and procedures of the study and are willing to participate in the study. Informed consent must be obtained prior to the commencement of any study-related tests or procedures that are not standard treatment for the subject's disease; 7. be willing and able to follow the taboos and restrictions specified in this programme.
Exclusion criteria
Exclusion criteria: (1) the patient had received allogeneic stem cell transplantation (SCT) or autologous stem cell transplantation (SCT) infusion within 12 weeks; (2) patients with clinical signs of MM meningeal involvement; (3) patients with grade 3 or above deep vein thrombosis or pulmonary embolism; (4) severe chronic obstructive pulmonary disease (forced expiratory volume in 1 second =3 years prior to enrollment; Or after adequate treatment of non-melanoma skin cancer, there is no evidence of disease; (6) the following heart diseases: New York heart association (NYHA) stage III or IV congestive heart failure; Myocardial infarction or coronary artery bypass bypass (CABG) at <=6 months prior to enrollment; Clinically significant ventricular arrhythmias, or a history of unexplained syncope, that are not vasovagal or due to dehydration; History of severe non-ischemic cardiomyopathy; Impaired cardiac function (LVEF < 45%) by echocardiography or MUGA scan evaluation (within 8 weeks before sampling); (7) a stroke or seizure occurred within 6 months prior to ICF signing; (8) human immunodeficiency virus (HIV) serum positive; (9) hepatitis b infection as defined in the ASCO guidelines. If the status of infection is unknown, a quantitative level is required to determine the status of infection; (10) having hepatitis c (positive for anti-hepatitis c virus [HCV] antibody or hcv-rna quantitative test) or a known history of hepatitis c; (11) oxygen absorption is required to maintain adequate blood oxygen saturation; (12) severe underlying conditions such as evidence of severe active virus, bacterial infection or uncontrolled systemic fungal infection; Active autoimmune disease or a history of autoimmune disease within 3 years; There is clear clinical evidence of dementia or altered mental states; (13) any problem that is not conducive to subjects receiving or tolerating planned treatment or understanding informed consent in the study center, or any condition in which participating in the study is not considered by the investigator to be in the best interest of the subjects (for example, to the detriment of health), or any condition that may prevent, limit, or confuse the evaluation required by the study protocol; (14) female subjects who were pregnant, breast-feeding or planning pregnancy during the study period or within 100 days after the study treatment; (15) male subjects who had family planning during the study period or within 100 days after the study treatment; (16) major surgery was performed within 2 weeks before the hxmm-drd regimen, or was planned during the study or within 2 weeks after the study treatment. (note: subjects who plan to undergo local anesthesia surgery may participate in this study.)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| OS;ORR;sCR;CR;VGPR;PR;SD; | — |
Countries
China
Contacts
Public ContactZhang Li
West China Hospital, Sichuan University
Outcome results
None listed