Fact CheckerSign in

NCT02316106CompletedPhase 2

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

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

Source: ClinicalTrials.gov · Last updated 23 Apr 2026

Brief summary (registry, in English)

The purpose of this study is to evaluate three daratumumab dose schedules in participants with Smoldering Multiple Myeloma.

Status (registry)
Completed
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
123 (actual)
First submitted
10 Dec 2014
Start date
20 May 2015
Primary completion date
2 Jun 2023
Lead sponsor
Janssen Research & Development, LLC
NCT number
NCT02316106
EudraCT number
2014-005139-14

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 123
  • From 20 May 2015 to the primary completion date, 2 Jun 2023
  • 57 sites in 11 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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
  • 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

Other illness

  • 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

Other

  • Active multiple myeloma,requiring treatment as defined by the study protocol
  • Primary systemic AL (immunoglobulin light chain) amyloidosis

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (57)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
-
Coordinator of this site? Confirm its status
Box HillAustraliaUnknown status
-
Coordinator of this site? Confirm its status
ConcordAustraliaUnknown status
-
Coordinator of this site? Confirm its status
MelbourneAustraliaUnknown status
-
Coordinator of this site? Confirm its status
Woodville SouthAustraliaUnknown status
-
Coordinator of this site? Confirm its status
CalgaryCanadaUnknown status
-
Coordinator of this site? Confirm its status
EdmontonCanadaUnknown status
-
Coordinator of this site? Confirm its status
TorontoCanadaUnknown status
-
Coordinator of this site? Confirm its status
BrnoCzechiaUnknown status
-
Coordinator of this site? Confirm its status
Hradec KrálovéCzechiaUnknown status
-
Coordinator of this site? Confirm its status
PragueCzechiaUnknown status
-
Coordinator of this site? Confirm its status
BerlinGermanyUnknown status
-
Coordinator of this site? Confirm its status
ChemnitzGermanyUnknown status
-
Coordinator of this site? Confirm its status
EssenGermanyUnknown status
-
Coordinator of this site? Confirm its status
HeidelbergGermanyUnknown status
-
Coordinator of this site? Confirm its status
MainzGermanyUnknown status
-
Coordinator of this site? Confirm its status
MünchenGermanyUnknown status
-
Coordinator of this site? Confirm its status
TübingenGermanyUnknown status
-
Coordinator of this site? Confirm its status
WürzburgGermanyUnknown status
-
Coordinator of this site? Confirm its status
LilleFranceUnknown status
-
Coordinator of this site? Confirm its status
NantesFranceUnknown status
-
Coordinator of this site? Confirm its status
ParisFranceUnknown status
-
Coordinator of this site? Confirm its status
Pierre-BéniteFranceUnknown status
-
Coordinator of this site? Confirm its status
RennesFranceUnknown status
-
Coordinator of this site? Confirm its status
CardiffUnited KingdomUnknown status
-
Coordinator of this site? Confirm its status
NottinghamUnited KingdomUnknown status
-
Coordinator of this site? Confirm its status
SouthamptonUnited KingdomUnknown status
-
Coordinator of this site? Confirm its status
SurreyUnited KingdomUnknown status
-
Coordinator of this site? Confirm its status
HaifaIsraelUnknown status
-
Coordinator of this site? Confirm its status
JerusalemIsraelUnknown status
-
Coordinator of this site? Confirm its status
Petah TikvaIsraelUnknown status
-
Coordinator of this site? Confirm its status
Tel AvivIsraelUnknown status
-
Coordinator of this site? Confirm its status
AmsterdamNetherlandsUnknown status
-
Coordinator of this site? Confirm its status
RotterdamNetherlandsUnknown status
-
Coordinator of this site? Confirm its status
UtrechtNetherlandsUnknown status
-
Coordinator of this site? Confirm its status
Nizhny NovgorodRussiaUnknown status
-
Coordinator of this site? Confirm its status
PetrozavodskRussiaUnknown status
-
Coordinator of this site? Confirm its status
RyazanRussiaUnknown status
-
Coordinator of this site? Confirm its status
Saint PetersburgRussiaUnknown status
-
Coordinator of this site? Confirm its status
Ann ArborUnited StatesUnknown status
-
Coordinator of this site? Confirm its status
AtlantaUnited StatesUnknown status
-
Coordinator of this site? Confirm its status
BostonUnited StatesUnknown status
-
Coordinator of this site? Confirm its status
Chapel HillUnited StatesUnknown status
-
Coordinator of this site? Confirm its status
CincinnatiUnited StatesUnknown status
-
Coordinator of this site? Confirm its status
ColumbusUnited StatesUnknown status
-
Coordinator of this site? Confirm its status
HackensackUnited StatesUnknown status
-
Coordinator of this site? Confirm its status
JacksonvilleUnited StatesUnknown status
-
Coordinator of this site? Confirm its status
Little RockUnited StatesUnknown status
-
Coordinator of this site? Confirm its status
NashvilleUnited StatesUnknown status
-
Coordinator of this site? Confirm its status
New YorkUnited StatesUnknown status
-
Coordinator of this site? Confirm its status
PhiladelphiaUnited StatesUnknown status
-
Coordinator of this site? Confirm its status
SeattleUnited StatesUnknown status
-
Coordinator of this site? Confirm its status
St LouisUnited StatesUnknown status
-
Coordinator of this site? Confirm its status
West Palm BeachUnited StatesUnknown status
-
Coordinator of this site? Confirm its status
AnkaraTurkey (Türkiye)Unknown status
-
Coordinator of this site? Confirm its status
AntalyaTurkey (Türkiye)Unknown status
-
Coordinator of this site? Confirm its status
IzmirTurkey (Türkiye)Unknown status
-
Coordinator of this site? Confirm its status
SamsunTurkey (Türkiye)Unknown status

This page is information, not medical advice. Discuss any trial with your doctor.