VRD as Induction Followed by VR Maintenance in Patients With Newly Diagnosed High Risk Multiple Myeloma

Launched by SUN YAT-SEN UNIVERSITY · Aug 19, 2018

Keywords

ClinConnect Summary

This clinical trial is studying a treatment for patients who have recently been diagnosed with high-risk multiple myeloma, a type of blood cancer. The researchers want to see how well a combination of medications, specifically bortezomib and lenalidomide, works when given as maintenance therapy after patients have initially received a different combination of treatments that includes lenalidomide, bortezomib, and dexamethasone. The goal is to determine if this approach can help manage the disease more effectively and safely.

To be eligible for this trial, patients must have a new diagnosis of multiple myeloma and show specific high-risk characteristics, such as certain genetic changes or advanced disease stages. They also need to have measurable signs of the disease and a reasonable level of health, verified by certain lab tests. Participants can expect to receive regular check-ups and monitoring throughout the study, and they will contribute to important research that may improve future treatments for multiple myeloma. It's important to note that patients who have certain health conditions or other serious diseases may not qualify for this trial.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patient has a newly diagnosis of multiple myeloma
• • Patient requires treatment for multiple myeloma
• • Subject have high-risk characteristics.Our definition for high risk multiple myeloma :(1) with cytogenetic abnormalities including del(17p),t(4;14),t(14;16),and/or t(14;20) ;(2) R-ISS III；(3) ISS III and no complete remission is achieved before maintenance therapy.
• • Subject has measurable disease as defined by \> 0.5 g/dL serum monoclonal protein, \>10 mg/dL involved serum free light chain (either kappa or lambda) provided that the serum free light chain ratio is abnormal, \>0.2 g/24 hrs urinary M-protein excretion, and/or measurable plasmacytoma(s) of at least 1cm in greatest dimension as measured by either CT scanning or MRI
• • Subject has a Karnofsky performance status ≥60%
• • Subject has a life expectancy ≥ 3 months
• * Subjects must meet the following laboratory parameters:
• • Absolute neutrophil count (ANC) ≥750 cells/mm3 (1.0 x 109/L) Hemoglobin ≥ 7 g/dL Platelet count ≥ 75,000/mm3 (30 x 109/L if extensive bone marrow infiltration) Serum SGOT/AST \<3.0 x upper limits of normal (ULN) Serum SGPT/ALT \<3.0 x upper limits of normal (ULN) Serum total bilirubin \<2.0 mg/dL (34 µmol/L) Creatinine clearance ≥ 30 cc/min
• Exclusion Criteria:
• • Subject has immeasurable MM (no measurable monoclonal protein, free light chains in blood or urine, or measureable plasmacytoma on radiologic scanning)
• • Subject has a prior history of other malignancies unless disease-free for ≥ 5 years, except for basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix or breast, or localized prostate cancer with Gleason score \< 7 with stable prostate specific antigen (PSA) levels
• • Subject has had myocardial infarction within 6 months prior to enrollment, or NYHA (New York Hospital Association) Class III or IV heart failure (see Appendix VI), Ejection Fraction \< 35%, uncontrolled angina, severe uncontrolled ventricular arrhythmias, electrocardiographic evidence of acute ischemia or active conduction system abnormalities
• • Female subject who is pregnant or lactating
• • Subject has known HIV infection
• • Subject has known active hepatitis B or hepatitis C infection
• • Subject has active viral or bacterial infections or any coexisting medical problem that would significantly increase the risks of this treatment program
• • Subject is unable to reliably take oral medications
• • Subject has a history of thromboembolic event within the past 4 weeks prior to enrollment
• • Subject has any clinically significant medical or psychiatric disease or condition that, in the investigator's opinion, may interfere with protocol adherence or a subject's ability to give informed consent