Actively Recruiting
DVRd in the Treatment of Patients With Newly Diagnosed Double-hit Multiple Myeloma
Led by Institute of Hematology & Blood Diseases Hospital, China · Updated on 2023-12-06
40
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 therapy
CONDITIONS
Official Title
DVRd in the Treatment of Patients With Newly Diagnosed Double-hit Multiple Myeloma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily signed informed consent form
- Age 18 years or older and younger than 70 years
- Newly diagnosed multiple myeloma with measurable disease according to IMWG criteria
- At least two high-risk cytogenetic abnormalities: t(4;14), t(14;16), t(14;20), del(17p), gain/amp(1q)
- ECOG performance status 0, 1, or 2; score 3 allowed if due to myeloma bone disease
- No prior anti-MM chemotherapy, extensive pelvic irradiation, or anti-MM glucocorticoids except short-term use for symptom control
- Total bilirubin less than 1.5 times ULN (or less than 3 times ULN in Gilbert's syndrome)
- AST and ALT less than or equal to 2.5 times ULN
- Creatinine clearance at least 30 mL/min
- Adequate blood counts before cycle 1
- Appropriate intervals after growth factor support or blood transfusions before screening
- No contraindications to prophylactic anticoagulant drugs
- Female participants of childbearing potential must use effective contraception and have a negative pregnancy test
You will not qualify if you...
- Primary plasma cell leukemia
- Secondary amyloidosis
- Central nervous system involvement
- Planning allogeneic hematopoietic stem cell transplantation
- Peripheral neuropathy greater than grade 2 or grade 2 with pain
- Intolerance, allergy, or contraindication to study drugs (glucocorticoids, bortezomib, lenalidomide, daratumumab)
- Significant heart disease or uncontrolled cardiac conditions
- Uncontrolled diabetes or hypertension
- History of other cancers within 5 years
- Active HIV infection or positive HIV test
- Active hepatitis B or C infection
- Pregnant or breastfeeding women
- Expected life expectancy under 6 months
- Uncontrolled gastrointestinal problems affecting tablet intake
- Major surgery within 2 weeks before screening or not fully recovered
- Receipt of live attenuated vaccines within 4 weeks prior to study drug
- Uncontrolled serious mental or physical illnesses
- Contraindications to concomitant drugs or supportive therapy
- Any condition that may interfere with study procedures or compliance
- Unwillingness or inability to follow the study protocol
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Institute of Hematology & Blood Diseases Hospital Chinese Academy of Medical Sciences
Tianjin, China
Actively Recruiting
Research Team
L
Lugui Qiu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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