Multiple myeloma
Conditions
Interventions
Experimental group:V-DECP alternating with Dara-VPD
Sponsors
Peking University People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Newly diagnosed ultra-high-risk multiple myeloma (according to the International Myeloma Working Group [IMWG] criteria), defined as: (1) By fluorescence in situ hybridization (FISH, CD138 magnetic beads sorting myeloma cells), >=2 patients with high cytogenetic risk were combined: del (17p), t (4; 14), t (14; 16), t (14; 20), Amp (1q); (2) Patients with the proportion of peripheral plasma cells >=5%, and/or the absolute value of peripheral plasma cells >=0.5x10^9/L; 2. Measurable disease, defined as one or more of the following (assessed within 21 days prior to treatment) : Serum M protein >= 10 g/L, urinary M protein >= 200 mg/24 hours, or in patients with no detectable serum or urinary M protein, serum free light chain (SFLC) > 100 mg/L (involved light chain) with abnormal ?/? ratio (SflC?/ ? ratio 1.65); 3. No gender limit, aged 18-65 years; 4. ECOG <= 2 points; 5. There are no serious organic lesions in the main organs (except renal insufficiency caused by this disease), can tolerate conventional anti-myeloma treatment, and meet the conditions of hematopoietic stem cell transplantation (autologous hematopoietic stem cell transplantation, allogeneic hematopoietic stem cell transplantation); 6. Female patients of reproductive age must have had a negative serum pregnancy test 21 days before entering the study and agreed to use effective contraceptive methods during the study observation period and 30 days after the study; 7. Agree and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Anti-MM therapy should not be received within 2 weeks before drug inclusion; 2. Patients diagnosed with amyloidosis (including primary and secondary amyloidosis), secondary plasma cell leukemia, or central nervous system involvement; 3. Prior malignant tumors requiring treatment or evidence of recurrence existed within 5 years prior to the initial study; 4. The patient has grade 2 or above peripheral neuropathy or neuropathic pain; 5. Active stage of hepatitis A, B, C infection or known positive HCV RNA or HBV-DNA; 6. HIV positive; 7. History of thrombosis before treatment; 8. Suffer from any concurrent medical condition or illness that may interfere with the study procedures or results; 9. Clinically significant heart disease; 10. Major surgery within 2 weeks prior to initial dosing; 11. Presence of gastrointestinal diseases that may significantly alter oral drug absorption; 12. Allergic to treatment medications; 13. Known or suspected failure to comply with the research programme; 14. Lactating patients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Very good partial response and complete response ratio; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival;Overall survival;Overall response rate; | — |
Countries
China
Contacts
Public ContactLu Jin
Peking University People's Hospital
Outcome results
None listed