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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03785184




Registration number
NCT03785184
Ethics application status
Date submitted
20/12/2018
Date registered
24/12/2018

Titles & IDs
Public title
A Study of Venetoclax Plus Lenalidomide and Dexamethasone for the Treatment of Newly Diagnosed t(11;14)-Positive Multiple Myeloma in Subjects Who Are Ineligible for High-Dose Therapy
Scientific title
A Phase 2, Multicenter, Single Arm, Open Label Study of Venetoclax Plus Lenalidomide and Dexamethasone for the Treatment of Newly Diagnosed t(11;14)-Positive Multiple Myeloma in Subjects Who Are Ineligible for High-Dose Therapy
Secondary ID [1] 0 0
M16-104
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional(has expanded access)
Description of intervention(s) / exposure
Treatment: Drugs - venetoclax
Treatment: Drugs - lenalidomide
Treatment: Drugs - dexamethasone

Experimental: Venetoclax + Lenalidomide + Dexamethasone - Venetoclax up to 800 mg orally every day (QD) QD on Days 1 - 28 plus lenalidomide up to 25 mg orally QD on Days 1 - 21 (28 day cycle) plus dexamethasone up to 40 mg orally once weekly (QW).


Treatment: Drugs: venetoclax
tablet; oral

Treatment: Drugs: lenalidomide
capsule; oral

Treatment: Drugs: dexamethasone
tablet; oral
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participates Who Achieve CR
Timepoint [1] 0 0
From baseline up to approximately 24 months
Secondary outcome [1] 0 0
Percent of Participants Who Achieve MRD Negativity
Timepoint [1] 0 0
From baseline up to approximately 24 months
Secondary outcome [2] 0 0
Percent of Participants Who Achieve VGPR or Better
Timepoint [2] 0 0
From baseline up to approximately 24 months
Secondary outcome [3] 0 0
Overall Response Rate (ORR)
Timepoint [3] 0 0
From baseline up to approximately 24 months
Secondary outcome [4] 0 0
Time to Response (TTR)
Timepoint [4] 0 0
From baseline up to approximately 24 months
Secondary outcome [5] 0 0
Duration of response (DOR)
Timepoint [5] 0 0
Approximately 7 years
Secondary outcome [6] 0 0
Progression-free Survival (PFS)
Timepoint [6] 0 0
Approximately 7 years
Secondary outcome [7] 0 0
Minimal Residual Disease (MRD) Negativity Rate at 12 Months
Timepoint [7] 0 0
Approximately 12 months after initial dose of study drug
Secondary outcome [8] 0 0
Time to Disease Progression (TTP)
Timepoint [8] 0 0
Approximately 7 years
Secondary outcome [9] 0 0
Time to Next Treatment (TTNT)
Timepoint [9] 0 0
Approximately 7 years
Secondary outcome [10] 0 0
Overall Survival (OS) Rate
Timepoint [10] 0 0
Approximately 7 years

Eligibility
Key inclusion criteria
* Must have documented, confirmed active multiple myeloma (MM) with greater than or equal to 10% clonal bone marrow plasma cells or biopsy-proven bone or extramedullary plasmacytoma and any one or more of the following myeloma-defining events:

* Evidence of end organ damage attributed to the underlying plasma cell proliferative disorder and satisfying at least one of the protocol specified laboratory criteria for calcium elevation, renal failure, anemia, or lytic bone lesions; OR
* One or more of the biomarkers of malignancy as described in the protocol.
* Must have MM positive for the t(11;14) translocation, as determined by methods described in the protocol.
* Must have measurable disease defined by at least one of the following criteria:

* Serum M-protein = 1.0 g/dL (immunoglobulin [Ig]G myeloma) or greater than or equal to 0.5 g/dL (IgA, IgM, IgD, or IgE myeloma);
* Urine M-protein greater than or equal to 200 mg/24 hours;
* Serum free light chain (FLC) greater than or equal to 10 mg/dL (100 mg/L) provided serum FLC ratio is abnormal.
* Newly diagnosed and not considered a candidate for high-dose therapy and hematopoietic stem cell transplantation (HSCT)
* Must have Eastern Cooperative Oncology Group performance status less than or equal to 2.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Has a co-existing condition as specified in the protocol.
* Has history of other active malignancies, including myelodysplastic syndromes (MDS) within the past 3 years with specific exceptions detailed in the protocol.
* Has been treated with or received any of the following:

* Prior or current systemic therapy or hematopoietic stem cell transplantation (HSCT) for MM (a short course of treatment with corticosteroids equivalent to dexamethasone 40 mg/day for a maximum of 4 days is allowed before treatment); use of systemic strong or moderate inhibitor or inducer of cytochrome P450(CYP)3A within 7 days before the first dose of study drug.
* Radiation therapy within 2 weeks of dosing
* Plasmapheresis within 4 weeks of dosing
* Immunization with live vaccine within 8 weeks of dosing
* Has a contraindication or inability to comply with antithrombotic prophylaxis.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
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
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
29/04/2019
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
22/08/2019
Sample size
Target
Accrual to date
Final
0
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 0 0
Westmead Hospital /ID# 210267 - Westmead
Recruitment hospital [2] 0 0
Flinders Centre for Innovation /ID# 210697 - Bedford Park
Recruitment hospital [3] 0 0
St. Vincents Hosp Melbourne /ID# 210266 - Fitzroy
Recruitment hospital [4] 0 0
Austin Hospital /ID# 210268 - Heidelberg
Recruitment hospital [5] 0 0
Monash Medical Centre /ID# 210269 - Melbourne
Recruitment postcode(s) [1] 0 0
2145 - Westmead
Recruitment postcode(s) [2] 0 0
5042 - Bedford Park
Recruitment postcode(s) [3] 0 0
3065 - Fitzroy
Recruitment postcode(s) [4] 0 0
3084 - Heidelberg
Recruitment postcode(s) [5] 0 0
3168 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Michigan
Country [3] 0 0
United States of America
State/province [3] 0 0
North Carolina
Country [4] 0 0
United States of America
State/province [4] 0 0
Pennsylvania
Country [5] 0 0
Canada
State/province [5] 0 0
Alberta
Country [6] 0 0
Canada
State/province [6] 0 0
Ontario
Country [7] 0 0
Canada
State/province [7] 0 0
Quebec
Country [8] 0 0
Spain
State/province [8] 0 0
Navarra, Comunidad
Country [9] 0 0
Spain
State/province [9] 0 0
Barcelona
Country [10] 0 0
Spain
State/province [10] 0 0
Madrid
Country [11] 0 0
Spain
State/province [11] 0 0
Valencia

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AbbVie
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Genentech, Inc.
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Commercial sector/industry
Name [2] 0 0
Celgene Corporation
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
AbbVie Inc.
Address 0 0
AbbVie
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR), Analytic code
When will data be available (start and end dates)?
Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
Available to whom?
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html


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/NCT03785184