Using bortezomib and lenalidomide for high-risk newly diagnosed multiple myeloma
Lenalidomide, Bortezomib, and Dexamethasone Combination Therapy as Induction Followed by Bortezomib and Lenalidomide Maintenance in Patients With Newly Diagnosed High Risk Multiple Myeloma
This study is testing if a combination of two medications, bortezomib and lenalidomide, can help keep high-risk patients with newly diagnosed multiple myeloma in better control of their disease after initial treatment.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Sun Yat-sen University Academic / other |
| Locations | 1 site (GuangZhou, Guangdong) |
| Trial ID | NCT03641456 on ClinicalTrials.gov |
What this trial studies
This phase 2 study evaluates the efficacy and safety of bortezomib in combination with lenalidomide as maintenance therapy for patients with newly diagnosed high-risk multiple myeloma. Patients initially receive a combination of lenalidomide, bortezomib, and dexamethasone as induction therapy to reduce tumor burden. Following this, the study assesses the effectiveness of bortezomib and lenalidomide in maintaining disease control. The treatment regimen includes subcutaneous bortezomib and oral lenalidomide and dexamethasone over a 28-day cycle, with the option for stem cell collection after three cycles.
Who should consider this trial
Good fit: Ideal candidates are patients with newly diagnosed multiple myeloma exhibiting high-risk characteristics and measurable disease.
Not a fit: Patients who do not have high-risk multiple myeloma or those who have already achieved complete remission may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved survival rates and disease control for patients with high-risk multiple myeloma.
How similar studies have performed: Other studies have shown promising results with similar combinations of bortezomib and lenalidomide in treating multiple myeloma, indicating a potential for success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
GuangZhou, Guangdong
- Sun Yat-sen University Cancer Center — GuangZhou, Guangdong, China (Recruiting)
Study contacts
- Principal investigator: Hua Wang, MD. — Sun Yat-sen University
- Study coordinator: Hua wang, MD.
- Email: wanghua@sysucc.org.cn
- Phone: 020-87342462
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.