Overview
DVRd in the Treatment of Patients With Newly Diagnosed Double-hit Multiple Myeloma
Status:
Recruiting
Recruiting
Trial end date:
2027-12-01
2027-12-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
Evaluate the efficacy of DVRd in patients with newly diagnosed double-hit multiple myeloma (MM) and the feasibility of minimal residual disease (MRD) guided maintenance therapyPhase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Institute of Hematology & Blood Diseases Hospital, China
Criteria
Inclusion Criteria:1. Voluntarily signing the Informed Consent Form (ICF).
2. Age: ≥ 18 years old and < 70 years old.
3. Newly diagnosed MM according to International Myeloma Working Group (IMWG) criteria,
with at least one measurable disease: The serum M protein detected by serum protein
electrophoresis (SPEP) is ≥ 1g/dL (≥ 10 g/L), or if it is immunoglobulin A (IgA) or
immunoglobulin D (IgD) subtype, quantitative levels of total IgA or IgD can be used as
a substitute; Or urine M-protein level ≥ 200 mg/24 h; Or if only the serum free light
chain (FLC) ratio is abnormal, the affected serum FLC ≥ 100 mg/L (normal FLC ratio:
0.26 to 1.65).
4. At least two high-risk cytogenetic abnormalities: t(4;14), t(14;16), t(14;20),
del(17p), gain/amp(1q) (the threshold for copy number variation is 20%, and the
threshold for translocation is 10%.
5. The Eastern Cooperative Oncology Group (ECOG) score is 0, 1, or 2 points. The ECOG
score of 3 points due to myeloma bone disease can be included.
6. Subjects had not received any anti-MM chemotherapy, extensive pelvic irradiation (more
than half of the pelvic area), or anti-MM glucocorticoids, except those who used
glucocorticoids for no more than 14 days to control symptoms.
7. Total bilirubin < 1.5 × upper limit of normal (ULN) (total bilirubin in patients with
Gilbert's syndrome can be restricted to <3 × ULN), and aspartate aminotransferase
(AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN.
8. Creatinine clearance rate ≥ 30 mL/min (calculated by cockcroft and Gault formulas).
9. Routine blood test within 7 days before the first day of cycle 1 meets the following
criteria: white blood cell (WBC) count ≥ 1.5×10^9/L, absolute neutrophil count ≥
1.0×10^9/L, hemoglobin ≥ 75 g/L, and platelet count ≥ 75×10^9/L (if bone marrow
plasmacytes < 50%) or platelet count ≥ 50×10^9/L (if bone marrow plasmacytes ≥ 50%).
10. Patients receiving erythropoietin, granulocyte colony stimulating factor (G-CSF),
granulocyte macrophage colony stimulating factor (GM-CSF), platelet agonists (for
example, eltrombopag, thrombopoietin, interleukin-11), must have a 2-week interval
between receiving growth factor support and screening assessment.
11. Patients receiving blood product transfusions: at least 2 weeks between hemoglobin
assessment and the last red blood cell (RBC) transfusion; at least one week between
platelet assessment and the last platelet transfusion.
12. The subjects have no contraindications of receiving prophylactic anticoagulant drug
recommended by the study.
13. Female subjects of childbearing age must meet the following two criteria: agree to
take effective contraceptive measures from the date of signing the ICF to 3 months
after the last administration of the drug; negative serum pregnancy test during
screening.
Exclusion Criteria:
1. Primary plasma cell leukemia.
2. Secondary amyloidosis.
3. Central nervous system (CNS) involvement.
4. Patients planning to receive allogeneic hematopoietic stem cell transplantation.
5. Patients with > grade 2 peripheral neuropathy or ≥ grade 2 peripheral neuropathy with
pain, regardless of receiving therapy or not.
6. Intolerance, allergy or contraindication to glucocorticoids, bortezomib, lenalidomide
or daratumumab.
7. Clinically significant heart diseases: myocardial infarction before screening, or
unstable or uncontrollable diseases related to or affecting cardiac function (such as
unstable angina, congestive heart failure, New York Heart Association classification
III-IV). Uncontrolled arrhythmia or clinically significant electrocardiogram (ECG)
abnormalities. During screening, the 12-lead ECG showed a corrected QT interval (QTc)
of > 470 msec.
8. Uncontrolled diabetes mellitus and hypertension.
9. Patients with a history of other malignant tumors within 5 years.
10. Active human immunodeficiency virus (HIV) infection or positive serum HIV.
11. Active hepatitis B or C infection. Hepatitis serological test should be performed
during screening. If hepatitis B surface antigen (HBsAg) and hepatitis B core antibody
(HBcAb) of patients are positive, DNA polymerase chain reaction (PCR) test should be
confirmed as negative before enrollment (After anti hepatitis B virus treatment, DNA
PCR test should be confirmed as negative before enrollment). If hepatitis C antibody
is positive, RNA PCR test should be performed, and the results should be confirmed as
negative before enrollment.
12. Pregnant or lactating women.
13. Expected life < 6 months.
14. Any uncontrolled gastrointestinal dysfunction that affects the capacity to ingest or
absorb the tablets.
15. A major surgery history within 2 weeks prior to the start of screening, or will not
fully recover from the surgery, or are scheduled for surgery during the study period.
Kyphoplasty or vertebroplasty is not considered as a major surgery. Notes: Subjects
who plan to undergo surgery under local anesthesia can participate in the study.
16. Patients who received attenuated live vaccines within 4 weeks prior to the first
administration of the study drug.
17. According to the researcher's judgment, any uncontrolled serious mental illness,
physical illness, or other symptoms/conditions that may affect treatment, compliance,
or the capacity to sign the ICF.
18. Patients with contraindications to any concomitant drugs or supportive therapy.
19. Patients with any diseases or complications that may interfere with the study
procedure.
20. Patients who are unwilling or unable to follow the protocol.