multiple myeloma (untreated) MedDRA version: 21.0 Level: LLT Classification code 10028228 Term: Multiple myeloma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Darzalex®
Product Name: DARZALEX
Pharmaceutical Form: Solution for injection
Sponsors
University of Cologne
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Untreated patients with multiple myeloma diagnosis according to the International myeloma working group (IMWG) diagnostic criteria • ECOG =2 • Not eligible or willing for autologous transplantation • Age 18 years or above • signed and written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 130
Exclusion criteria
Exclusion criteria: • Subject has received any multiple myeloma therapy previously except dexamethasone to a maximum cumulative dose of 160mg, emergency radiotherapy or surgery for symptom control • Participation in other interventional clinical trials • Subject has known meningeal involvement of multiple myeloma. • Subjects with plasma cell leukemia or AL amyloidosis • Non-hematologic malignancy within the past 2 years with the exception of a) adequately treated basal cell carcinoma, squamous cell skin cancer, or localized thyroid cancer; b) carcinoma in situ of the cervix or breast; c) prostate cancer of Gleason Grade 7 or less with stable prostate-specific antigen levels; or d) cancer considered cured by surgical resection or unlikely to impact survival during the duration of the study, such as localized transitional cell carcinoma of the bladder or benign tumors of the adrenal or pancreas. • Subject has either of the following: - Known chronic obstructive pulmonary disease (COPD) with a forced expiratory volume in 1 second (FEV1) <50% of predicted normal. Note that FEV1 testing is required for subjects suspected of having COPD and subjects must be excluded if FEV1 is <50% of predicted normal. - Known moderate or severe persistent asthma, within the past 2 years, uncontrolled asthma of any classification. Note that subjects who currently have controlled intermittent asthma or controlled mild persistent asthma are allowed to participate in the trial. - Subject is known to be seropositive for human immunodeficiency virus (HIV) - Active hepatitis B (defined by a positive test for HBV DNA) or hepatitis C (defined by a positive test for HCV-RNA-quantification). (Patients with a positive test for HBs antigen or antibodies, but negative HBC DNA may be included but must be monitored for HBV activation throughout the study.) - Subject has any concurrent medical condition or disease (e.g. active systemic infection) that is likely to interfere with trial procedures or results, or that in the opinion of the investigator would constitute a hazard for participating in this trial. - Concomitant chemotherapy or myeloma-specific therapy other than trial treatment (incl. standard intensification) is not permitted. The sponsor must be notified in advance (or as soon as possible thereafter) of any instances on which prohibited medications are administered. - Patients has known current symptomatic congestive heart failure (New York Heart Association Class III-IV, see APPENDIX III B) unstable angina pectoris, or uncontrolled cardiac arrythmia.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Investigate the safety and efficacy of daratumumab added to a standard induction regimen of bortezomib, cyclophosphamide and dexamethasone (VCd).;Secondary Objective: • Assess the efficacy of induction and maintenance therapy using daratumumab in combination with bortezomib/dexamethasone by evaluating MRD negativity before and during the maintenance therapy. • Evaluate the response and progression-free survival of a daratumumab-containing regimen at first progression/relapse 12 months after start of second line therapy.;Primary end point(s): • Response rate after 8 cycles of DVCd (=VGPR) ;Timepoint(s) of evaluation of this end point: Clinical response before Cycle 9 (Response will be assessed according to the International Myeloma Working Group Uniform (IMWG) Response Criteria) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Minimal residual disease (MRD) negativity at any time point before and during maintenance therapy (DVd) assessed by NGS at a level of 10e-5 • Progression-free survival at 12 months from start of second line therapy • Progression-free survival from trial inclusion (PFS) • Time to next treatment (TTNT) • Overall survival (OS) • Overall Response rate of first line treatment • Overall Response rate of second line Treatment • Minimal residual disease (MRD) negativity at any time before and during maintenance therapy (DVd) assessed by NGS at other thresholds or by Flow;Timepoint(s) of evaluation of this end point: Maintenance Phase: Response status will be assessed every 6 months Relapse Treatment Phase: Response status will be assessed after 2 cycles | — |
Countries
Germany
Contacts
Public ContactCologne Cancer Study Group
University Hospital of Cologne
Outcome results
None listed