Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02316106
Registration number
NCT02316106
Ethics application status
Date submitted
10/12/2014
Date registered
12/12/2014
Date last updated
16/08/2024
Titles & IDs
Public title
A Study to Evaluate 3 Dose Schedules of Daratumumab in Participants With Smoldering Multiple Myeloma
Query!
Scientific title
A Randomized Phase 2 Trial to Evaluate Three Daratumumab Dose Schedules in Smoldering Multiple Myeloma
Query!
Secondary ID [1]
0
0
54767414SMM2001
Query!
Secondary ID [2]
0
0
CR106449
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Multiple Myeloma
0
0
Query!
Condition category
Condition code
Cancer
0
0
0
0
Query!
Other cancer types
Query!
Cancer
0
0
0
0
Query!
Myeloma
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - daratumumab
Treatment: Drugs - daratumumab
Treatment: Drugs - daratumumab
Experimental: Arm A (Long Intense) -
Experimental: Arm B (Intermediate) -
Experimental: Arm C (Short Intense) -
Treatment: Drugs: daratumumab
16 mg/kg administered by intravenous (IV) infusion once every week in Cycle 1, every other week in Cycle 2 and Cycle 3, every 4 weeks in Cycle 4 to Cycle 7, and from Cycle 8 to Cycle 20 on Day 1 of each cycle. If, as per investigator discretion, there is a positive benefit/risk ratio, absence of Grade greater than or equal to (\>=) 3 treatment related toxicity, and at least stable disease has been achieved, treatment can be extended and given every 8 weeks after Cycle 20. For participants participating in treatment extension, the duration of infusion may be shortened to a 90-minute infusion or can switch to daratumumab 1800mg subcutaneous (Q8w).
Treatment: Drugs: daratumumab
16 mg/kg administered by IV infusion once every week in Cycle 1, and then on Day 1 of each cycle from Cycle 2 to Cycle 20, and every 8 weeks after Cycle 20. If, as per investigator discretion, there is a positive benefit/risk ratio, absence of Grade greater than or equal to (\>=) 3 treatment related toxicity, and at least stable disease has been achieved, treatment can be extended and given every 8 weeks after Cycle 20. For participants participating in treatment extension, the duration of infusion may be shortened to a 90-minute infusion or can switch to daratumumab 1800mg subcutaneous (Q8w).
Treatment: Drugs: daratumumab
16 mg/kg administered by IV infusion once every week in Cycle 1 only. Treatment cycles are 8 weeks in length.
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
The percentage of participants who achieve a complete response (CR)
Query!
Assessment method [1]
0
0
CR, defined having negative immunofixation on the serum and urine, and \<5% plasma cells (PCs) in bone marrow.
Query!
Timepoint [1]
0
0
Up to 7 years
Query!
Primary outcome [2]
0
0
The percentage of participants that have an event (disease progression or death) per patient-year
Query!
Assessment method [2]
0
0
Query!
Timepoint [2]
0
0
Up to 7 years
Query!
Secondary outcome [1]
0
0
The percentage of participants who are minimal residual disease (MRD) negative
Query!
Assessment method [1]
0
0
Query!
Timepoint [1]
0
0
Up to 7 years
Query!
Secondary outcome [2]
0
0
Time to next treatment (TNT)
Query!
Assessment method [2]
0
0
TNT, defined as the time from the date of randomization to the date of the first subsequent multiple myeloma treatment.
Query!
Timepoint [2]
0
0
Up to 7 years
Query!
Secondary outcome [3]
0
0
The percentage of participants who achieve a Complete Response (CR) or a Partial Response (PR)
Query!
Assessment method [3]
0
0
See definition of CR above. PR, defined as \>=50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by \>=90% or to \<200 mg/24 hours.
Query!
Timepoint [3]
0
0
Up to 7 years
Query!
Secondary outcome [4]
0
0
The median time of progression free survival (PFS)
Query!
Assessment method [4]
0
0
PFS is defined as time from date of randomization to date of initial documented disease progression (PD) according to SLiM-CRAB (S=sixty, Li=light chains, M=MRI, C=calcium \[elevated\], R=renal failure, A=anemia, B=bone lesions) criteria, myeloma defining events, or date of death, whichever occurs first. As per SLiM-CRAB criteria, clonal bone marrow plasma cell percentage \>=60%, Involved : uninvolved serum free Li ratio \>= 100, \>1 focal lesion on MRI studies, calcium elevation: \>0.25 millimole per liter (mmol/L) ( \>1 milligram per deciliter \[mg/dL\]) higher than upper limit of normal or \>2.75 mmol/L (\>11 mg/dL); creatinine clearance \<40 milliliter per minute (mL/min) or serum creatinine \>177 micromole per liter (µmol/L) (\>2 mg/dL); hemoglobin \<10 gram per deciliter (g/dL) (\<6.5 mmol/L) or \>2 g/dL (\>1.25 mmol/L) lower than lower limit of normal; 1 or more osteolytic lesions on skeletal radiography, computed tomography (CT), or positron emission tomography-CT (PET-CT).
Query!
Timepoint [4]
0
0
Up to 7 years
Query!
Secondary outcome [5]
0
0
The percentage of participants with symptomatic multiple myeloma
Query!
Assessment method [5]
0
0
Query!
Timepoint [5]
0
0
Up to 7 years
Query!
Secondary outcome [6]
0
0
Response to first subsequent multiple myeloma treatment
Query!
Assessment method [6]
0
0
Query!
Timepoint [6]
0
0
Up to 7 years
Query!
Secondary outcome [7]
0
0
Overall survival rate
Query!
Assessment method [7]
0
0
Query!
Timepoint [7]
0
0
Up to 7 years
Query!
Eligibility
Key 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.
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key 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
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 2
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
20/05/2015
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
3/06/2024
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
123
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Recruitment hospital [1]
0
0
- Box Hill
Query!
Recruitment hospital [2]
0
0
- Concord
Query!
Recruitment hospital [3]
0
0
- Melbourne
Query!
Recruitment hospital [4]
0
0
- Woodville South
Query!
Recruitment postcode(s) [1]
0
0
- Box Hill
Query!
Recruitment postcode(s) [2]
0
0
- Concord
Query!
Recruitment postcode(s) [3]
0
0
- Melbourne
Query!
Recruitment postcode(s) [4]
0
0
- Woodville South
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Arkansas
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Florida
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Georgia
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Massachusetts
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Michigan
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Missouri
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
New Jersey
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
New York
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
North Carolina
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Ohio
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Pennsylvania
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Tennessee
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Washington
Query!
Country [14]
0
0
Canada
Query!
State/province [14]
0
0
Alberta
Query!
Country [15]
0
0
Canada
Query!
State/province [15]
0
0
Ontario
Query!
Country [16]
0
0
Czechia
Query!
State/province [16]
0
0
Brno
Query!
Country [17]
0
0
Czechia
Query!
State/province [17]
0
0
Hradec Kralove
Query!
Country [18]
0
0
Czechia
Query!
State/province [18]
0
0
Praha 2
Query!
Country [19]
0
0
France
Query!
State/province [19]
0
0
Lille
Query!
Country [20]
0
0
France
Query!
State/province [20]
0
0
Nantes
Query!
Country [21]
0
0
France
Query!
State/province [21]
0
0
Paris
Query!
Country [22]
0
0
France
Query!
State/province [22]
0
0
Pierre Benite
Query!
Country [23]
0
0
France
Query!
State/province [23]
0
0
Rennes Cedex
Query!
Country [24]
0
0
Germany
Query!
State/province [24]
0
0
Berlin
Query!
Country [25]
0
0
Germany
Query!
State/province [25]
0
0
Chemnitz
Query!
Country [26]
0
0
Germany
Query!
State/province [26]
0
0
Essen
Query!
Country [27]
0
0
Germany
Query!
State/province [27]
0
0
Heidelberg
Query!
Country [28]
0
0
Germany
Query!
State/province [28]
0
0
Mainz
Query!
Country [29]
0
0
Germany
Query!
State/province [29]
0
0
München
Query!
Country [30]
0
0
Germany
Query!
State/province [30]
0
0
Tuebingen
Query!
Country [31]
0
0
Germany
Query!
State/province [31]
0
0
Würzburg
Query!
Country [32]
0
0
Israel
Query!
State/province [32]
0
0
Haifa
Query!
Country [33]
0
0
Israel
Query!
State/province [33]
0
0
Jerusalem
Query!
Country [34]
0
0
Israel
Query!
State/province [34]
0
0
Petah Tikva
Query!
Country [35]
0
0
Israel
Query!
State/province [35]
0
0
Tel Aviv
Query!
Country [36]
0
0
Netherlands
Query!
State/province [36]
0
0
Amsterdam
Query!
Country [37]
0
0
Netherlands
Query!
State/province [37]
0
0
Rotterdam
Query!
Country [38]
0
0
Netherlands
Query!
State/province [38]
0
0
Utrecht
Query!
Country [39]
0
0
Russian Federation
Query!
State/province [39]
0
0
Nizhny Novgorod
Query!
Country [40]
0
0
Russian Federation
Query!
State/province [40]
0
0
Petrozavodsk
Query!
Country [41]
0
0
Russian Federation
Query!
State/province [41]
0
0
Ryazan
Query!
Country [42]
0
0
Russian Federation
Query!
State/province [42]
0
0
St-Petersburg
Query!
Country [43]
0
0
Turkey
Query!
State/province [43]
0
0
Ankara
Query!
Country [44]
0
0
Turkey
Query!
State/province [44]
0
0
Antalya
Query!
Country [45]
0
0
Turkey
Query!
State/province [45]
0
0
Izmir
Query!
Country [46]
0
0
Turkey
Query!
State/province [46]
0
0
Samsun
Query!
Country [47]
0
0
United Kingdom
Query!
State/province [47]
0
0
Cardiff
Query!
Country [48]
0
0
United Kingdom
Query!
State/province [48]
0
0
Nottingham
Query!
Country [49]
0
0
United Kingdom
Query!
State/province [49]
0
0
Southampton
Query!
Country [50]
0
0
United Kingdom
Query!
State/province [50]
0
0
Surrey
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Janssen Research & Development, LLC
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
The purpose of this study is to evaluate three daratumumab dose schedules in participants with Smoldering Multiple Myeloma.
Query!
Trial website
https://clinicaltrials.gov/study/NCT02316106
Query!
Trial related presentations / publications
Chari A, Munder M, Weisel K, Jenner M, Bygrave C, Petrucci MT, Boccadoro M, Cavo M, van de Donk NWCJ, Turgut M, Demirkan F, Karadogan I, Libby E, Kleiman R, Kuppens S, Bandekar R, Neff T, Heuck C, Qi M, Clemens PL, Goldschmidt H. Evaluation of Cardiac Repolarization in the Randomized Phase 2 Study of Intermediate- or High-Risk Smoldering Multiple Myeloma Patients Treated with Daratumumab Monotherapy. Adv Ther. 2021 Feb;38(2):1328-1341. doi: 10.1007/s12325-020-01601-w. Epub 2021 Jan 20. Landgren CO, Chari A, Cohen YC, Spencer A, Voorhees P, Estell JA, Sandhu I, Jenner MW, Williams C, Cavo M, van de Donk NWCJ, Beksac M, Moreau P, Goldschmidt H, Kuppens S, Bandekar R, Clemens PL, Neff T, Heuck C, Qi M, Hofmeister CC. Daratumumab monotherapy for patients with intermediate-risk or high-risk smoldering multiple myeloma: a randomized, open-label, multicenter, phase 2 study (CENTAURUS). Leukemia. 2020 Jul;34(7):1840-1852. doi: 10.1038/s41375-020-0718-z. Epub 2020 Feb 5.
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Janssen Research & Development, LLC Clinical Trial
Query!
Address
0
0
Janssen Research & Development, LLC
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT02316106
Download to PDF