A Phase 3 Randomized, Multicenter Study of Subcutaneous Daratumumab Versus Active Monitoring in Subjects with High-risk Smoldering Multiple Myeloma

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 10

Inclusion Criteria

# At least 18 years of age with an Eastern Cooperative Oncology Group (ECOG)
performance status score of 0 or 1
# Diagnosis of SMM for <=5 years with measurable disease (defined as serum M
protein >=10 g/L or urine M protein >=200 mg/24 hours or involved serum Free
Light Chain (FLC) >=100 mg/L and abnormal serum FLC ratio)
# Clonal Bone Marrow Plasma Cells (BMPCs) >=10% and at least 1 of the following:
*Serum M protein >=30 g/L and/or *IgA SMM and/or Immunoparesis with reduction of
2 uninvolved immunoglobulin isotypes and/or *Serum involved:uninvolved FLC
ratio >=8 and <100 and/or *Clonal BMPCs >50% to <60%
# Laboratory values as defined by the protocol
# Use of highly effective contraceptive methods

Exclusion Criteria

# Active multiple myeloma, requiring treatment as defined by the study protocol
# Primary systemic AL (immunoglobulin light chain) amyloidosis
# Prior or concurrent exposure to any of the following: *Approved or
investigational treatments for SMM or multiple myeloma, *Daratumumab or other
anti-CD38 therapies, *Corticosteroids with a dose exceeding 10 mg prednisone
per day or equivalent, *Investigational drug (including investigational
vaccines) or invasive investigational medical device within 4 weeks or 5
half-lives before Cycle 1 Day 1
# Received treatment for a malignancy (other than SMM) within 3 years before
the date of randomization (exceptions in the protocol)
# Known or suspected Chronic Obstructive Pulmonary Disease (COPD) and/or
moderate or severe persistent asthma within the past 2 years
# Known to be seropositive for HIV
#Seropositive for Hepatitis B. Amendment 3 change: Local testing and results
of hepatitis B serology (Includes HBsAg, anti-HBs, and anti-HBc) is required
for all patients prior to randomization when this amendment 3 is implemented.
# Known to be seropositive for hepatitis C
# Concurrent medical or psychiatric condition or 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
# Clinically significant cardiac disease
# Pregnant, breast-feeding, or planning to become pregnant while receiving
study treatment or within 3 months after the last dose of daratumumab

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Reduction of risk to disease progression or death, instigated by daratumumab<br /><br>treatment.<br /><br>Assumption: Daratumumab treatment will reduce the risk of disease progression<br /><br>or death by 37,5% with median PFS of 48 months for daratumumab compared to 30<br /><br>months for active monitoring.</p><br>

Secondary Outcome Measures