Multiple Myeloma
Conditions
Sponsors
Janssen Pharmaceutical K.K.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Participant with documented multiple myeloma satisfying the CRAB criteria and measurable disease - Participants who are newly diagnosed and not considered candidate for high-dose chemotherapy with stem cell transplantation (SCT) due to: being age >=65 years, or in participants <65 years: presence of important comorbid conditions likely to have a negative impact on tolerability of high dose chemotherapy with stem cell transplantation - Participant must have an Eastern Cooperative Oncology Group (ECOG)performance status score of 0, 1, or 2 - Meet the clinical laboratory criteria as specified in the protocol - A woman of childbearing potential must have a negative serum pregnancy test at screening within 14 days prior to randomization - Women of childbearing potential must commit to either abstain continuously from heterosexual sexual intercourse or to use 2 methods of reliable birth control simultaneously. This includes one highly effective form of contraception (tubal ligation, intrauterine device, hormonal [birth control pills, injections, hormonal patches, vaginal rings or implants] or partner's vasectomy) and one additional effective contraceptive method (male latex or synthetic condom, diaphragm, or cervical cap). Contraception must begin prior to dosing. Reliable contraception is indicated even where there has been a history of infertility, unless due to hysterectomy or bilateral oophorectomy
Exclusion criteria
Exclusion criteria: - Participant has a diagnosis of primary amyloidosis, monoclonal gammopathy of undetermined significance, or smoldering multiple myeloma - Participant has a diagnosis of Waldenstrom's disease, or other conditions in which IgM M-protein is present in the absence of a clonal plasma cell infiltration with lytic bone lesions - Participant has prior or current systemic therapy or stem cell transplantation (SCT) for multiple myeloma, with the exception of an emergency use of a short course of corticosteroids before treatment - Participant has peripheral neuropathy or neuropathic pain Grade 2 or higher, as defined by the national cancer institute common terminology criteria for adverse events (NCI CTCAE) Version - Participant has a history of malignancy (other than multiple myeloma) within 3 years before the date of randomization (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy that in the opinion of the investigator, with concurrence with the sponsor's medical monitor, is considered cured with minimal risk of recurrence within 3 years) - Participant has any concurrent medical or psychiatric condition or disease (example active systemic infection, uncontrolled diabetes, acute diffuse infiltrative pulmonary disease) that is likely to interfere with the study procedures or results, or that in the opinion of the investigator, would constitute a hazard for participating in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy Progression-free Survival (PFS) The PFS is defined as time from date of randomization to either progressive disease (PD), or death, whichever occurs first. PD will be determined according to International Myeloma Working Group (IMWG) criteria. | — |
Secondary
| Measure | Time frame |
|---|---|
| efficacy Time to Disease Progression (TTP) The TTP is defined as the time from the date of randomization to the date of first documented evidence of PD as defined by IMWG criteria. efficacy Complete Response (CR) Percentage of participants with CR, as defined by the IMWG criteria efficacy Minimal Residual Disease (MRD) Negativity Rate MRD negativity rate, defined as the proportion of participants who have negative MRD at any time point after the date of randomization. efficacy Progression Free Survival on Next Line of Therapy(PFS2) The PFS2 is defined as the time from randomization to disease progression on the next line of treatment or death, whichever comes first. Disease progression will be based on Investigator judgment. defined as the time from randomization to the start of the next-line treatment. efficacy Overall Response Rate (ORR) The ORR is defined as the proportion of participants who achieve PR or better according to IMWG criteria, during or after study treatment. efficacy Stringent Complete Response (sCR) The sCR rate is defined as the percentage of participants with sCR, as defined by the IMWG criteria. efficacy Very Good Partial Response (VGPR) or Better The VGPR or better rate, defined as the proportion of participants achieving VGPR and CR (including sCR) according to the IMWG criteria during or after the study treatment. efficacy Time to Response Time to response, defined as the time between randomization and the first efficacy evaluation that the participant has met all criteria for PR or better. efficacy Duration of Response Duration of response is time from the date of initial documentation of response (PR or better) to the date of first documented evidence of PD, as defined by IMWG criteria. efficacy Overall Survival (OS) The OS is defined as the time from the date of randomization to the date of the participant's death. efficacy Impact of D-VMP compared to VMP on patient-reported perception of global health. The EORTC-QLQ-C30, EQ- 5 | — |
Countries
Europe, Japan, North America, Oceania
Outcome results
None listed