Study of Ixazomib + Daratumumab + Dexamethasone (IDd) in Relapsed and/or Refractory Multiple Myeloma (RRMM)
- Conditions
- Relapsed and/or Refractory Multiple MyelomaMedDRA version: 16.1 Level: HLT Classification code 10028229 Term: Multiple myelomas System Organ Class: 100000004851Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2017-003977-32-PL
- Lead Sponsor
- Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Not specified
- Target Recruitment
- 60
Adult patients (aged =18 years) who have been diagnosed with MM according to IMWG criteria
? All patients must have measurable disease by at least 1 of the following measurements:
o Serum M-protein =1 g/dL (=10 g/L).
o Urine M-protein =200 mg/24 hours.
? All patients must have documented evidence of PD on or after their last regimen as defined by IMWG criteria. All
patients must have received between 1 to 3 prior therapies for MM.
? All patients must have achieved a response (partial response [PR] or better) to at least 1 prior therapy.
? All patients must have an Eastern Cooperative Oncology Group (ECOG) score of 0, 1, or 2.
? All patients must have adequate hematologic, hepatic, and renal function.
*Full details in Section 7.0.
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 24
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 36
?Patients meeting any of the following exclusion criteria are not to be enrolled in the study:
? Patients have undergone prior allogenic bone marrow transplantation.
? Patients have received prior ixazomib at any time or daratumumab or other anti-CD38 therapies except as part of initial therapy if this was stopped to move on to stem cell transplant (SCT) and the patient did not progress on anti-CD38 treatment.
? Patients are refractory to bortezomib or carfilzomib at the last exposure before this study (defined as patient
having PD while receiving bortezomib or carfilzomib therapy or within 60 days after ending bortezomib therapy).
? Patients planning to undergo a SCT prior to PD on this study (ie, these patients should not be enrolled in order to
reduce disease burden prior to transplant).
? Patients with Grade 2 or higher residual toxicities from prior therapy (including Grade 2 or higher peripheral
neuropathy or any grade neuropathy with pain; excluding alopecia).
? Patient has any concurrent medical condition or disease that is likely to interfere with study procedures, results, or
assessment of safety or toxicity or that in the opinion of the investigator would constitute a hazard for
participating in this study.
*Full details in Section 7.0.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the proportion of patients with a response of very good partial response (VGPR) or better to ixazomib +daratumumab+dexamethasone (IDd) treatment.;<br> Secondary Objective: To measure progression-free survival (PFS), time to progression (TTP), and overall survival (OS).<br> To measure overall response rate (ORR), time to response (TTR), and duration of response (DOR).<br> To collect plasma concentration-time data for ixazomib to contribute to population pharmacokinetic (PK)<br> analyses.<br> To evaluate the safety/tolerability of IDd administered in a 28-day cycle.<br> ;Primary end point(s): The rate of Very Good Partial Response VGPR or better, as evaluated by the investigator according to IMWG criteria, in patients that are response-evaluable;Timepoint(s) of evaluation of this end point: Up to 3 years
- Secondary Outcome Measures
Name Time Method