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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT03785184
Other study ID # M16-104
Secondary ID
Status Withdrawn
Phase Phase 2
First received
Last updated
Start date April 29, 2019
Est. completion date August 22, 2019

Study information

Verified date August 2019
Source AbbVie
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study will evaluate the safety and preliminary efficacy of venetoclax when combined with lenalidomide and dexamethasone for participants with newly diagnosed, active t(11;14) positive multiple myeloma (MM).

This study will consist of 2 parts: Part 1 Dose Escalation and Part 2 Dose Expansion.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date August 22, 2019
Est. primary completion date August 22, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

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


Related Conditions & MeSH terms


Intervention

Drug:
venetoclax
tablet; oral
lenalidomide
capsule; oral
dexamethasone
tablet; oral

Locations

Country Name City State
Australia Flinders Centre for Innovation /ID# 210697 Bedford Park South Australia
Australia St. Vincents Hosp Melbourne /ID# 210266 Fitzroy Victoria
Australia Austin Hospital /ID# 210268 Heidelberg Victoria
Australia Monash Medical Centre /ID# 210269 Melbourne Victoria
Australia Westmead Hospital /ID# 210267 Westmead New South Wales
Canada Tom Baker Cancer Centre /ID# 208549 Calgary Alberta
Canada Hopital Maisonneuver-Rosemont /ID# 208550 Montreal Quebec
Canada McGill Univ HC /ID# 208486 Montreal Quebec
Canada Princess Margaret Cancer Centr /ID# 208923 Toronto Ontario
Spain Hospital Clinic de Barcelona /ID# 209888 Barcelona
Spain Clinica Universitar de Navarra - Madrid /ID# 210131 Madrid
Spain Hosp Univ 12 de Octubre /ID# 209887 Madrid
Spain Hspital Universitario Gregorio Maranon /ID# 209926 Madrid
Spain Clinica Universitar de Navarra - Pamplona /ID# 209883 Pamplona Navarra, Comunidad
Spain Hospital Univ Dr. Peset /ID# 209884 Valencia
United States Henry Ford Hospital /ID# 208481 Detroit Michigan
United States Karmanos Cancer Institute /ID# 208805 Detroit Michigan
United States City of Hope /ID# 212211 Duarte California
United States Duke University Hospital /ID# 208306 Durham North Carolina
United States Marin Cancer Care /ID# 208476 Greenbrae California
United States University of California, Los Angeles /ID# 208516 Los Angeles California
United States UPMC Hillman Cancer Ctr /ID# 208121 Pittsburgh Pennsylvania

Sponsors (3)

Lead Sponsor Collaborator
AbbVie Celgene Corporation, Genentech, Inc.

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of Participates Who Achieve CR Complete response (CR) is defined as negative immunofixation of serum and urine, and disappearance of any soft tissue plasmacytomas, and < 5% plasma cells in bone marrow. From baseline up to approximately 24 months
Secondary Percent of Participants Who Achieve MRD Negativity Minimal residual disease (MRD) negative after treatment is described as less than one myeloma cell per 100,000 bone marrow cells. From baseline up to approximately 24 months
Secondary Percent of Participants Who Achieve VGPR or Better Very Good Partial Response (VGPR) per international myeloma working group (IMWG) criteria is defined as serum or urine myeloma protein (m-protein) detectable by immunofixation but not on electrophoresis, or greater than or equal to 90% reduction in serum m-protein and urine m-protein less than 100 mg/24 hours. From baseline up to approximately 24 months
Secondary Overall Response Rate (ORR) ORR is described as the percentage of participants who experience partial response (PR) or better; PR per IMWG is described as follows:
= 50% reduction of serum M-protein and reduction in 24-hour urinary M protein by = 90% or to < 200 mg/24 h
If the serum and urine M-protein are not measurable, a decrease = 50% in the difference between involved and uninvolved free light chain (FLC) levels is required in place of the M-protein criteria
If serum and urine M-protein are not measurable, and serum free light assay is also not measurable, = 50% reduction in bone marrow plasma cells is required in place of M-protein, provided baseline percentage was = 30%
In addition, if present at baseline, = 50% reduction in size of soft tissue plasmacytomas is also required
From baseline up to approximately 24 months
Secondary Time to Response (TTR) Time to response is defined as the time from randomization to the first response (CR, stringent complete response [sCR], VGPR, PR). From baseline up to approximately 24 months
Secondary Duration of response (DOR) DOR is defined as the time from first observation of PR to the time of disease progression, with deaths from causes other than progression censored. Approximately 7 years
Secondary Progression-free Survival (PFS) PFS is defined as time from start of the treatment to disease progression or death (regardless of cause of death), whichever comes first. Approximately 7 years
Secondary Minimal Residual Disease (MRD) Negativity Rate at 12 Months Percent of participants meeting the MRD Negative criteria at 12 months after initial dose; MRD Negative defined as less than one myeloma cell per 100,000 bone marrow cells. Approximately 12 months after initial dose of study drug
Secondary Time to Disease Progression (TTP) TTP is defined as the time from start of treatment to disease progression, with deaths from causes other than progression censored. Approximately 7 years
Secondary Time to Next Treatment (TTNT) The time to next treatment is defined as the time between the date of the first study drug intake and the date of the first next treatment intake after study drug discontinuation. Approximately 7 years
Secondary Overall Survival (OS) Rate OS was defined as the time from the date the participant was randomized to the date of death. Approximately 7 years
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