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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT03301220




Registration number
NCT03301220
Ethics application status
Date submitted
29/09/2017
Date registered
4/10/2017
Date last updated
25/04/2024

Titles & IDs
Public title
A Study of Subcutaneous Daratumumab Versus Active Monitoring in Participants With High-Risk Smoldering Multiple Myeloma
Scientific title
A Phase 3 Randomized, Multicenter Study of Subcutaneous Daratumumab Versus Active Monitoring in Subjects With High-Risk Smoldering Multiple Myeloma
Secondary ID [1] 0 0
54767414SMM3001
Secondary ID [2] 0 0
CR108172
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Smoldering Multiple Myeloma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Other cancer types
Cancer 0 0 0 0
Myeloma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Daratumumab SC: daratumumab + rHuPH20

No Intervention: Arm A: Active Monitoring - Participants randomized to active monitoring will receive no study medication, but will undergo the same disease evaluations at the same frequency as participants randomized to daratumumab.

Experimental: Arm B: Daratumumab SC - Participants will receive 1800 milligram (mg) of daratumumab co-formulated with 2000 units per milliliter (U/mL) of recombinant human hyaluronidase (rHuPH20) by subcutaneous (SC) injection until 39 cycles or up to 36 months or until confirmed disease progression, unacceptable toxicity or withdrawal from the study treatment, study termination or study completion.


Treatment: Drugs: Daratumumab SC: daratumumab + rHuPH20
Participants will receive daratumumab SC injection (daratumumab 1800 mg + rHuPH20 [2000 U/mL]) once weekly for Cycles 1 and 2 (Days 1, 8, 15, and 22 of each week), every 2 weeks for Cycle 3 to Cycle 6 (Days 1 and 15), and thereafter every 4 weeks (Day 1) until 39 cycles or up to 36 months or until confirmed disease progression, unacceptable toxicity or withdrawal from the study treatment, study termination or study completion. Each cycle is 28 days in duration.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-free Survival (PFS)
Timepoint [1] 0 0
From the date of randomization to active multiple myeloma (MM) or the date of death, whichever occurs first (up to approximately 8 years)
Secondary outcome [1] 0 0
Time to Biochemical or Diagnostic (SLiM-CRAB) Progression
Timepoint [1] 0 0
Up to biochemical or diagnostic progression (up to approximately 8 years)
Secondary outcome [2] 0 0
Overall Response Rate (ORR)
Timepoint [2] 0 0
Up to approximately 8 years
Secondary outcome [3] 0 0
Complete Response (CR) Rate
Timepoint [3] 0 0
Up to approximately 8 years
Secondary outcome [4] 0 0
Time to First-Line Treatment for Multiple Myeloma (MM)
Timepoint [4] 0 0
Post-progressive disease (PD) follow-up, every 6 months until end of study (up to approximately 8 years)
Secondary outcome [5] 0 0
Progression-Free Survival on First-Line Treatment for MM (PFS2)
Timepoint [5] 0 0
Post-PD follow-up, every 6 months until end of study (up to approximately 8 years)
Secondary outcome [6] 0 0
Overall Survival (OS)
Timepoint [6] 0 0
Throughout study, and at least every 3 months until PD; post-PD, every 6 months until end of study (up to approximately 8 years)
Secondary outcome [7] 0 0
Percentage of Participants who Progress to MM With Adverse Prognostic Features
Timepoint [7] 0 0
At screening and PD (up to approximately 8 years)
Secondary outcome [8] 0 0
Serum Daratumumab Pharmacokinetic (PK) Concentration
Timepoint [8] 0 0
Cycles 1 and 3: Day 1 predose, and Day 4 postdose; Cycles 5, 7, 12, and 24: Day 1 predose; end of the treatment (EOT: 28 days after the last daratumumab dose); and 8 weeks after the last daratumumab dose (up to approximately 3 years and 8 weeks)
Secondary outcome [9] 0 0
Maximum Observed Concentration (Cmax) of Daratumumab
Timepoint [9] 0 0
Cycles 1 and 3: Day 1 predose, and Day 4 postdose; Cycles 5, 7, 12, and 24: Day 1 predose; end of the treatment (EOT: 28 days after the last daratumumab dose); and 8 weeks after the last daratumumab dose (up to approximately 3 years and 8 weeks)
Secondary outcome [10] 0 0
Minimum Observed Concentration (Cmin) of Daratumumab
Timepoint [10] 0 0
Cycles 1 and 3: Day 1 predose, and Day 4 postdose; Cycles 5, 7, 12, and 24: Day 1 predose; end of the treatment (EOT: 28 days after the last daratumumab dose); and 8 weeks after the last daratumumab dose (up to approximately 3 years and 8 weeks)
Secondary outcome [11] 0 0
Number of Participants With Anti-daratumumab Antibodies
Timepoint [11] 0 0
Cycles 1,3,5,7,12, and 24: Predose on Day 1; end of treatment (28 days after the last daratumumab dose), and 8 weeks after the last daratumumab dose (up to approximately 3 years and 8 weeks)
Secondary outcome [12] 0 0
Number of Participants With Anti-Recombinant Human Hyaluronidase (rHuPH20) Antibodies
Timepoint [12] 0 0
Cycles 1,3,5,7,12, and 24: Predose on Day 1; end of treatment (28 days after the last daratumumab dose), and 8 weeks after the last daratumumab dose (up to approximately 3 years and 8 weeks)
Secondary outcome [13] 0 0
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Score
Timepoint [13] 0 0
Baseline, Weeks 12, 24, and 60, every year until end of treatment (EOT)/active monitoring, pre-PD follow-up (every year until end of study or PD), PD, and Months 3, 6, 12, and 18 post-PD (up to approximately 8 years)
Secondary outcome [14] 0 0
Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Future Perspective Scale
Timepoint [14] 0 0
Baseline, Weeks 12, 24, and 60, every year until end of treatment (EOT)/active monitoring, pre-PD follow-up (every year until end of study or PD), PD, and Months 3, 6, 12, and 18 post-PD (up to approximately 8 years)
Secondary outcome [15] 0 0
Change From Baseline in European Quality (EuroQoL) 5-Dimension 5-Level Health Status (EQ-5D-5L) Questionnaire
Timepoint [15] 0 0
Baseline, Weeks 12, 24, and 60, every year until end of treatment (EOT)/active monitoring, pre-PD follow-up (every year until end of study or PD), PD, and Months 3, 6, 12, and 18 post-PD (up to approximately 8 years)
Secondary outcome [16] 0 0
Duration of Response
Timepoint [16] 0 0
From the date of initial documentation of a response to the date of first documented evidence of PD (up to approximately 8 years)
Secondary outcome [17] 0 0
Time to Response
Timepoint [17] 0 0
Up to End of Treatment (up to approximately 39 cycles [each cycle of 28 days] or 36 months, whichever occurs first)

Eligibility
Key inclusion criteria
- Diagnosis of high risk smoldering multiple myeloma (SMM) (per International Myeloma
Working Group [IMWG] criteria) for less than or equal to (<=) 5 years with measurable
disease at the time of randomization, defined as serum M protein greater than or equal
to (>=) 10 gram per liter (g/L) or urine M protein >= 200 milligram per 24 hours
(mg/24 hours) or involved serum free light chain (FLC) >=100 milligram per liter
(mg/L) and abnormal serum FLC ratio

- Clonal bone marrow plasma cells (BMPCs) >= 10 percentage (%); and at least 1 of the
following risk factors; Serum M protein >= 30 g/L, immunoglobulin (Ig)A SMM,
immunoparesis with reduction of 2 uninvolved immunoglobulin isotypes (only IgA, IgM,
and IgG should be considered in determination for immunoparesis; IgD and IgE are not
considered in this assessment), serum involved: uninvolved FLC ratio >= 8 and less
than (<) 100, or clonal BMPCs greater than (>) 50% to <60% with measurable disease

- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1

- Women of childbearing potential must commit to either abstain continuously from
heterosexual sexual intercourse or to use highly effective method of contraception

- A woman of childbearing potential must have a negative serum or urine pregnancy test
at screening within 14 days prior to randomization

- During the study and for 3 months after receiving the last dose of daratumumab, a
woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted
reproduction
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Multiple myeloma (MM), requiring treatment, defined by any of the following:

1. Bone lesions (1 or more osteolytic lesions on low-dose whole body computed
tomography [LDCT], positron-emission tomography with computed tomography [PET-CT]
or CT). Participants who have benign/post-traumatic bone lesions visible on
screening images as well as previous imaging, may be considered for inclusion.
Details (diagnosis, location, duration) on benign/post-traumatic pre-existing
bone lesions that can be seen on the screening images (example [eg.], old
fractures) and were also present on previous imaging are to be reported in the
case report form (CRF)

2. Hypercalcemia (serum calcium greater than [>]0.25 millimoles per liter [mmol/L]
[>1 milligram per deciliter {mg/dL}] higher than upper limit of normal [ULN] or
>2.75 mmol/L [>11 mg/dL]). Participants who have clinically stable hypercalcemia
attributable to a disease other than multiple myeloma (eg, hyperparathyroidism)
may be considered for inclusion after a case by case review by the medical
monitor

3. Renal insufficiency, preferably determined by creatinine clearance less than
(<)40 milliliter per minute (mL/min) measured or estimated using the Modification
of Diet in Renal Disease (MDRD), or serum creatinine >177 micromole per liter
(µmol/L). Participants who have clinically stable renal insufficiency
attributable to a disease other than multiple myeloma (eg, glomerulonephritis)
may be considered for inclusion after a case by case review by the medical
monitor

4. Anemia, defined as hemoglobin <10 gram per deciliter (g/dL) or >2 g/dL below
lower limit of normal or both; transfusion support or concurrent treatment with
erythropoietin stimulating agents is not permitted. Participants who have
clinically stable anemia attributable to a disease other than multiple myeloma
(eg, thalassemia, vitamin B12 deficiency, iron deficiency) may be considered for
inclusion after a case by case review by the medical monitor

5. Clonal BMPC percentage >=60%

6. Serum FLC ratio (involved:uninvolved) >=100 (the involved FLC must be >=100 mg/L)

7. More than 1 focal lesion >=5 millimeter (mm) in diameter by magnetic resonance
imaging (MRI)

- Primary systemic amyloid light-chain (AL) (immunoglobulin light chain) amyloidosis

- Exposure to any of the following:

1. Prior exposure to daratumumab or prior exposure to other anti-Cluster of
Differentiation 38 (anti-CD38) therapies

2. Prior exposure to approved or investigational treatments for SMM or MM (including
but not limited to conventional chemotherapies, immunomodulatory agent [IMiDs],
or proteasome inhibitor [PIs]). Stable standard dosing of bisphosphonate and
denosumab as indicated for osteoporosis is acceptable

3. Exposure to investigational drug (including investigational vaccines) or invasive
investigational medical device for any indication within 4 weeks or 5 half-lives,
whichever is longer, before Cycle 1, Day 1

4. Ongoing treatment with corticosteroids with a dose >10 milligram (mg) prednisone
or equivalent per day at the time of randomization; or >280 mg cumulative
prednisone dose or equivalent for any 4-week period in the year prior to
randomization

5. Ongoing treatment with other monoclonal antibodies (eg, infliximab, rituximab),
immunomodulators (eg, abatacept, methotrexate, azathioprine, cyclosporine) or
other treatments that are likely to interfere with the study procedures or
results

- Received treatment (chemotherapy, surgery, et cetera [etc]) for a malignancy (other
than SMM) within 3 years before the date of randomization (exceptions are squamous and
basal cell carcinomas of the skin, carcinoma in situ of the cervix or breast, or other
non-invasive lesion), which is considered cured with minimal risk of recurrence within
3 years

- Medical or psychiatric condition or disease (for example, active systemic disease
[including presence of auto-antibodies], uncontrolled diabetes) 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

- Known allergies, hypersensitivity, or intolerance to corticosteroids, monoclonal
antibodies, hyaluronidase, or other human proteins, or their excipients, or known
sensitivity to mammalian-derived products (including dairy allergy)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
7/11/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
11/07/2025
Actual
Sample size
Target
Accrual to date
Final
390
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Austin Hospital - Heidelberg
Recruitment hospital [2] 0 0
Calvary Mater Newcastle Hospital - Waratah
Recruitment hospital [3] 0 0
The Perth Blood Institute - West Perth
Recruitment hospital [4] 0 0
Queen Elizabeth Hospital - Woodville
Recruitment postcode(s) [1] 0 0
3150 or 3084 - Heidelberg
Recruitment postcode(s) [2] 0 0
2298 - Waratah
Recruitment postcode(s) [3] 0 0
6005 - West Perth
Recruitment postcode(s) [4] 0 0
5011 - Woodville
Recruitment outside Australia
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Muenster
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Ulm
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Ramat Gan
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Roma
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Torino
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Kurume
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Kyoto
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Matsuyama
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Petrozavodsk
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Ryazan
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Pamplona
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Pozuelo De Alarcon, Madrid
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Spain
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Salamanca
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Spain
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Valencia
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Sweden
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Falun
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Sweden
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Luelå
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Sweden
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Stockholm
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Turkey
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Ankara
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Edirne
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Turkey
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Istanbul
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Turkey
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Kayseri
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Turkey
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Samsun
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United Kingdom
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Birmingham
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Bristol
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United Kingdom
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Canterbury
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London
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United Kingdom
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Manchester
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Nottingham
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United Kingdom
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Stoke-On-Trent

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Janssen Research & Development, LLC
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The primary objective of this study is to determine whether treatment with daratumumab
administered subcutaneously (SC) prolongs progression-free survival (PFS) compared with
active monitoring in participants with high-risk smoldering multiple myeloma (SMM).
Trial website
https://clinicaltrials.gov/ct2/show/NCT03301220
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Janssen Research & Development, LLC Clinical Trial
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Janssen Research & Development, LLC
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Contact person for public queries
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Contact person for scientific queries