Primary Objective- To evaluate if daratumumab can effectively decrease M protein in subjects with intermediate or high-risk SMM as assessed by CR rate- To determine if daratumumab reduces the progression/death rate in subjects with intermediate or…
ID
Source
Brief title
Condition
- Haematopoietic neoplasms (excl leukaemias and lymphomas)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To determine the best dose regimen of treatment with daratumumab in Smoldering
Multiple Myeloma patients.
Secondary outcome
N/A
Background summary
Two hypotheses will be tested:
1. The CR rate at 6 months after the last subject is randomized is greater than
or equal to 35%.
2. The disease progression [PD]/death rate one year after the last subject is
randomized is less than or equal to 0.185.
Study objective
Primary Objective
- To evaluate if daratumumab can effectively decrease M protein in subjects
with intermediate or high-risk SMM as assessed by CR rate
- To determine if daratumumab reduces the progression/death rate in subjects
with intermediate or high-risk SMM
Secondary Objectives
The secondary objectives are:
- To evaluate preliminary efficacy, including Overall Response Rate (ORR) and
progressionfree survival (PFS)
- To evaluate the minimal residual disease (MRD) negative rate
- To evaluate the pharmacokinetics and immunogenicity of daratumumab
- To assess the safety profile of daratumumab given in 3 different dosing
schedules
- To determine if daratumumab has an effect on QT interval
Study design
This is a randomized study to compare three different dosing schedules of
daratumumab.
Intervention
Refer to table 3 on page 18 of the protocol.
Study burden and risks
The adverse events observed mostly related to the administration of daratumumab
were fever, high protein levels in the urine, fatigue, infusion-related
reactions, diarrhea, cough, infection of the nose, sinuses and/or throat,
nausea, dizziness, colds and back pain. Refer to the patient information sheet
for a complete overview.
Graaf Engelbertlaan 75
Breda 4837 DS
NL
Graaf Engelbertlaan 75
Breda 4837 DS
NL
Listed location countries
Age
Inclusion criteria
- diagnosis of smoldering multiple myeloma (SMM) for less than 5 years , - have
a confirmed diagnosis of intermediate or high-risk SMM, and an Eastern
Cooperative Oncology Group (ECOG) performance status score of 0 or 1
Exclusion criteria
1. Active multiple myeloma, requiring treatment as defined by the study
protocol
2. Primary systemic AL (immunoglobulin light chain) amyloidosis
3. Prior or concurrent exposure to any of the following: approved or
investigational treatments for SMM or/and multiple myeloma, daratumumab or
other anti CD-38 therapies, treatment with bone-protecting agents (eg,
bisphosphonates, denosumab) or corticosteroids with a dose not exceeding 10 mg
prednisone per day or equivalent are only allowed if given in a stable dose and
for a nonmalignant condition, or received an investigational drug (including
investigational vaccines) or used an invasive investigational medical device
within 4 weeks before Cycle 1, Day 1
4. history of malignancy (other than SMM) within 3 years before the date of
randomization, except for the following if treated and not active: basal cell
or nonmetastatic squamous cell carcinoma of the skin, cervical carcinoma in
situ, ductal carcinoma in situ of breast, or International Federation of
Gynecology and Obstetrics (FIGO) Stage 1 carcinoma of the cervix
5. Known chronic obstructive pulmonary disease (COPD) OR moderate or severe
persistent asthma within the past 2 years
6. Subject is known to be seropositive for human immunodeficiency virus (HIV)
OR known to have history of hepatitis C OR known to be seropositive for
hepatitis B
7. Any concurrent medical or psychiatric condition or disease (eg, autoimmune
disease, active systemic disease, myelodysplasia) 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
8. Subject has clinically signifcant cardiac disease.
9. Screening QT interval (QTcF) > 470 msec.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2014-005139-14-NL |
| ClinicalTrials.gov | NCT02316106 |
| CCMO | NL52170.029.15 |