A Randomized Phase 2 Trial to Evaluate Three Daratumumab Dose Schedules in Smoldering Multiple Myeloma

Phase 2

Recruiting

• Conditions: Smoldering Multiple Myeloma - asymptomatic plasma cell disorder; 10018865

• Registration Number: NL-OMON54517
• Lead Sponsor: Janssen-Cilag

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 6

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To determine the best dose regimen of treatment with daratumumab in Smoldering<br /><br>Multiple Myeloma patients.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>N/A</p><br>