A Study to Evaluate 3 Dose Schedules of Daratumumab in Participants with Smoldering Multiple Myeloma

Phase 1

• Conditions: Smoldering multiple myeloma; MedDRA version: 18.1Level: LLTClassification code 10028228Term: Multiple myelomaSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2014-005139-14-CZ
• Lead Sponsor: Janssen-Cilag International N.V.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-05-15
• Last Update Posted: 6 February 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 120

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

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 72
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 48

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/and multiple myeloma, daratumumab or other anti CD-38 therapies, treatment with corticosteroids with a
dose greater than (>) 10 milligram (mg) prednisone per day or equivalent and bone-protecting agents (eg,
bisphosphonates, denosumab) or 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
- 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
- known chronic obstructive pulmonary disease (COPD) OR moderate or severe persistent asthma within the past 2 years
- 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified