A prospective, randomized controlled study to compare clinical outcomes between bortezomib-melphalan-prednisolone and lenaldomide-dexamethasone in patients with transplant-ineligible, newly diagnosed multiple myeloma
- Conditions
- Neoplasms
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 552
Individual to participate this clinical trial should meet all of the following criteria:
1) At least 18 years old (or legal consent age in the jurisdiction where the clinical trial is being conducted)
2) Elevated calcium, renal insufficiency, anemia and bone abnormality (CRAB), recorded multiple myeloma satisfying the presence of =10% monoclonal plasma cells in the bone marrow or plasmacytoma as evidenced by biopsy, and defined as one of the following Diseases that can be measured and evaluated by central clinical laboratory:
- =0.5 g / dL (=5 g / L) for subjects with serum M-protein =1 g / dL (=10 g / L) or IgA, IgD, IgE or IgM multiple myeloma; or
- Urine M-protein level =200 mg / 24 hours; or
- Serum immunoglobulin free light chain (FLC) =10 mg / dL and abnormal serum immunoglobulin kappa lambda FLC ratio in the absence of measurable M-protein in serum or urine.
3) Newly diagnosed and not considered candidates for high-dose chemotherapy with hematopoietic stem cell transplantation (SCT) due to: age =70 years,
or <70 year old subjects: the presence of a comorbid condition that may have a negative effect on the tolerability of high-dose chemotherapy with hematopoietic stem cell transplantation.
: Prior to randomization, a review of these comorbidities and approvals by investigator is required
4) ECOG performance status score 0, 1, 2 or 3
5) A participant must sign the informed consent form (or must be signed by a representative of the subject) stating that participant understand the purpose and necessary procedures of the study and is willing to participate in the study.
6) Women of childbearing potential must continue to ban coitus or use two reliable methods of contraception. These include one high-efficiency contraceptive method (tubal ligation, intrauterine device, hormone [tablet for contraception, injection, hormonal patch, vaginal ring or implantation] or vaginal resection of partner) and one additional effective method of contraception (male latex or synthetic) Condoms, contraceptive diaphragms or neck caps). Contraception must begin 4 weeks prior to administration. Unless you have hysterectomy, reliable contraception is required even if you have a history of infertility.
7) Women of childbearing potential must have a negative serum or urine pregnancy test at screening within 14 days prior to randomization.
Subjects who meet any of the following criteria are excluded from clinical trial participation:
1) Primary amyloidosis, POEMS syndrome (multiple neuropathy, long-term hypertrophy, endocrine disease, monoclonal protein and skin changes), monoclonal gamma disease or asymptomatic multiple myeloma. Unexplained monoclonal gamma disease is the presence of serum M-protein <3 g / dL; Absence of renal failure associated with soluble bone lesions, anemia, hypercalcemia and M-protein; And (when measured) defined as a percentage of plasma cells in bone marrow below 10%. Asymptomatic multiple myeloma is defined as asymptomatic multiple myeloma without associated organ or tissue damage or terminal organ damage. Waldenström disease or soluble bone Other conditions in which IgM M protein is present without clonal plasma cell infiltration with lesions.
2) Treatment with previous or current systemic therapy for multiple myeloma, except for emergency use of short-term courses of corticosteroids (equivalent to dexamethasone 40 mg / day for up to 4 days) prior to randomization
3) Peripheral neuropathy or neuropathic pain of grade 2 or higher, as defined by the National Cancer Institute Adverse Response Common Terminology (NCI CTCAE) version 4.03.
4) Patients who are not treated despite presence of active HBV or HCV activation or HIV infection
5) If the severity of peripheral neuropathy is 3 or higher before screening
6) Concomitant medical or psychiatric conditions or disorders that the investigator has determined are likely to interfere with clinical trial procedures or results, or that it may be dangerous to participate in clinical trials (e.g., active systemic infection, uncontrolled diabetes, acute diffuse invasive lung) disease).
7) It is known or suspected that the protocol cannot be followed (eg due to alcoholism, drug dependence or mental disorders). Subjects whose status is determined as ineligible to participate clinical trial by the investigator to participate not the best for the subject or may prevent, limit or interfere with the protocol-specific evaluation.
8) Subject who is pregnant or lactating or plan to become pregnant within 3 months of the last dose of any component of the treatment regimen.
9) subjects who have a plan to become the father while enrolled in this study or within 3 months of the last dose of any component of the treatment regimen.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall survival
- Secondary Outcome Measures
Name Time Method progression-free survival;Interval to next treatment;Overall response rate;rates of very good partial response or better;rates of complete response or better;Duration to partial response or better;Duration to partial response