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Multiple MyelomaPhase 2NCT03785184

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

A Phase 2 study testing venetoclax, lenalidomide and dexamethasone in people with Multiple Myeloma, run by AbbVie at 22 sites in 4 countries.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Multiple Myeloma
What is being tested?
venetoclax, lenalidomide and dexamethasone
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
22 sitesin 4 countries
Study dates
29 Apr 2019to 22 Aug 2019
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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);
Show all 10Show fewer
  • 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.

Who cannot join

  • 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.

Trial locations and contacts

22 sites in 4 countries.

22 sites in 4 countries

United States7 sites

  • Karmanos Cancer Institute /ID# 208805

    Detroit, Michigan, 48201

  • Henry Ford Hospital /ID# 208481

    Detroit, Michigan, 48202

  • City of Hope /ID# 212211

    Duarte, California, 91010

  • Duke University Hospital /ID# 208306

    Durham, North Carolina, 27710

  • Marin Cancer Care /ID# 208476

    Greenbrae, California, 94904

  • University of California, Los Angeles /ID# 208516

    Los Angeles, California, 90095

  • UPMC Hillman Cancer Ctr /ID# 208121

    Pittsburgh, Pennsylvania, 15232

Other trials in United States

Spain6 sites

  • Hospital Clinic de Barcelona /ID# 209888

    Barcelona, 08036

  • Hspital Universitario Gregorio Maranon /ID# 209926

    Madrid, 28009

  • Clinica Universitar de Navarra - Madrid /ID# 210131

    Madrid, 28021

  • Hosp Univ 12 de Octubre /ID# 209887

    Madrid, 28041

  • Clinica Universitar de Navarra - Pamplona /ID# 209883

    Pamplona, Navarra, Comunidad, 31008

  • Hospital Univ Dr. Peset /ID# 209884

    Valencia, 46017

Other trials in Spain

Australia5 sites

  • Flinders Centre for Innovation /ID# 210697

    Bedford Park, South Australia, 5042

  • St. Vincents Hosp Melbourne /ID# 210266

    Fitzroy, Victoria, 3065

  • Austin Hospital /ID# 210268

    Heidelberg, Victoria, 3084

  • Monash Medical Centre /ID# 210269

    Melbourne, Victoria, 3168

  • Westmead Hospital /ID# 210267

    Westmead, New South Wales, 2145

Other trials in Australia

Canada4 sites

  • Tom Baker Cancer Centre /ID# 208549

    Calgary, Alberta, T2N 4N2

  • Hopital Maisonneuver-Rosemont /ID# 208550

    Montreal, Quebec, H1T 2M4

  • McGill Univ HC /ID# 208486

    Montreal, Quebec, H3G 1A4

  • Princess Margaret Cancer Centr /ID# 208923

    Toronto, Ontario, M5G 2M9

Other trials in Canada

About this study

Official 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

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.

Keywords
Multiple Myeloma, Cancer, t(11;14)-Positive Multiple Myeloma, Venetoclax, Lenalidomide
Medical subject headings
Multiple Myeloma, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT03785184
Study groupRoleWhat they receive
Venetoclax + Lenalidomide + DexamethasoneExperimentalVenetoclax 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).
Receives: Drug: venetoclax; Drug: lenalidomide; Drug: dexamethasone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: From baseline up to approximately 24 months

Secondary outcomes (10)

  1. 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.

    Measured: From baseline up to approximately 24 months

  2. 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.

    Measured: From baseline up to approximately 24 months

  3. 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

    Measured: From baseline up to approximately 24 months

  4. 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).

    Measured: From baseline up to approximately 24 months

  5. 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.

    Measured: Approximately 7 years

  6. 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.

    Measured: Approximately 7 years

  7. 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.

    Measured: Approximately 12 months after initial dose of study drug

  8. 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.

    Measured: Approximately 7 years

  9. 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.

    Measured: Approximately 7 years

  10. Overall Survival (OS) Rate

    OS was defined as the time from the date the participant was randomized to the date of death.

    Measured: Approximately 7 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Dec 2018
  2. Study start29 Apr 2019 (estimated)
  3. Primary completion22 Aug 2019
  4. Study completion22 Aug 2019

Why it stopped: Strategic considerations

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03785184
Sponsor's protocol ID
M16-104
Status last verified
Aug 2019
First submitted
20 Dec 2018
Last updated
28 Aug 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.
Expanded access
Available

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing venetoclax, lenalidomide and dexamethasone in people with Multiple Myeloma, run by AbbVie at 22 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 28 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 22 sites in United States, Spain, Australia, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participates Who Achieve CR (time frame: From baseline up to approximately 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03785184.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2019.

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