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Relapsed/Refractory Multiple MyelomaPhase 1/2NCT01794520

Study Evaluating ABT-199 in Participants With Relapsed or Refractory Multiple Myeloma

A Phase 1/2 study testing Venetoclax and Dexamethasone in people with Relapsed/Refractory Multiple Myeloma, run by AbbVie at 29 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The Phase 1 primary objectives of this study were to assess the safety profile, characterize pharmacokinetics (PK) and determine the dosing schedule, maximum tolerated dose (MTD), and recommended Phase 2 dose (RPTD) of ABT-199 (venetoclax) when administered in participants with relapsed or refractory multiple myeloma. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Relapsed/Refractory Multiple Myeloma
What is being tested?
Venetoclax and Dexamethasone
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
117 participants
Where
29 sitesin 4 countries
Study dates
10 Oct 2012to 29 Nov 2021
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • ECOG (Eastern Cooperative Oncology Group) performance score of 1 or 0. Participants in the Phase 2 portion: ECOG performance score of 2, 1, or 0.
  • Diagnosis of multiple myeloma (MM) previously treated with at least one prior line of therapy.
  • Induction therapy followed by stem cell transplant and maintenance therapy will be considered a single line of therapy.
  • For Safety Expansion, participants must have been previously treated with a proteasome inhibitor (e.g., bortezomib) and an immunomodulatory agent (e.g., thalidomide, lenalidomide).
  • For Venetoclax-Dexamethasone Combination, participants must have been previously treated with a proteasome inhibitor (e.g., bortezomib) and an immunomodulatory agent (e.g., thalidomide, lenalidomide) AND have t(11;14)-positive multiple myeloma per the central lab testing.
  • For Phase 2, participants must have MM positive for the t(11;14) translocation, as determined by an analytically validated fluorescence in situ hybridization (FISH) assay per the central laboratory testing (enrollment with local t(11;14)-positive FISH results only will be considered at the discretion of the Therapeutic Area MD). Participants must have evidence of disease progression on or within 60 days of last dose of most recent previous treatment based on International Myeloma Working Group (IMWG) criteria AND must have previously received at least 2 lines of therapy, including an immunomodulatory drug (lenalidomide or pomalidomide), a proteasome inhibitor (bortezomib, carfilzomib or ixazomib), daratumumab, and glucocorticoids.
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  • For US participants: Daratumumab combination regimen must be one of the prior lines of therapy (for this study, daratumumab plus corticosteroids will not be considered a combination regimen).
  • For Non-US participants: Either daratumumab monotherapy or combination therapy is acceptable. Daratumumab monotherapy will be limited to approximately 20 percent of the total number of Phase 2 participants.
  • Measurable disease at Screening:
  • Serum monoclonal protein of at least 1.0 g/dL (10g/L) by protein electrophoresis.
  • At least 200 mg of monoclonal protein in the urine on 24-hr electrophoresis.
  • Serum immunoglobulin free light chain of at least 10 mg/dL and abnormal serum immunoglobulin kappa to lambda free light chain ratio.
  • Participants with a history of autologous or allogenic stem cell transplantation must have adequate peripheral blood counts independent of any growth factor support, and have recovered from any transplant related toxicity(s) and be:
  • At least 100 days post-autologous transplant prior to first dose of study drug or
  • At least 6 months post-allogenic transplant prior to first dose of study drug and not have active graft-versus-host disease (GVHD), i.e., requiring treatment.
  • Meet the following laboratory parameters, per the reference range, at least once during the screening period:
  • Absolute Neutrophil Count (ANC) of at least 1000/μL (Participants may use growth factor support to achieve ANC eligibility criteria).
  • Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) not higher than 3 x Upper Limit of Normal Range (ULN).
  • Calculated creatinine clearance of at least 30 mL/min using a modified Cockcroft-Gault calculation.
  • Platelet count of at least 30,000 mm³ (independent of transfusion for 2 weeks).
  • Hemoglobin of at least 8.0 g/dL (participants may receive blood transfusion to achieve hemoglobin eligibility criteria).
  • Total bilirubin not higher than 1.5 x ULN (Participants with Gilbert's Syndrome may have bilirubin higher than 1.5 x ULN).

Who cannot join

  • Exhibits evidence of other clinically significant uncontrolled condition(s), including, but not limited to:
  • Acute infection within 14 days prior to first dose of study drug requiring antibiotic, antifungal, or antiviral therapy.
  • Diagnosis of fever and neutropenia within 1 week prior to first dose of study drug.
  • Cardiovascular disability status of New York Heart Association Class ≥ 3.
  • Significant history of renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, cardiovascular or hepatic disease, within the last 6 months that, in the opinion of the investigator, would adversely affect his/her participation in the study.
  • History of other active malignancies other than multiple myeloma within the past 3 years prior to study entry, with the following exceptions:
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  • Adequately treated in situ carcinoma of the cervix uteri;
  • Basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin;
  • Localized prostate cancer Gleason grade 6 or lower AND with stable prostate specific antigen (PSA) levels off treatment
  • Previous malignancy confined and surgically resected (or treated with other modalities) with curative intent.
  • Known Human Immunodeficiency Viral (HIV) infection.
  • Active hepatitis B or C infection.

Trial locations and contacts

29 sites in 4 countries.

29 sites in 4 countries

United States21 sites

  • University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 170007

    Ann Arbor, Michigan, 48109

  • Emory University, Winship Cancer Institute /ID# 74993

    Atlanta, Georgia, 30322

  • Tufts Medical Center /ID# 203814

    Boston, Massachusetts, 02111-1552

  • University Hospitals - Seidman Cancer Center /ID# 204502

    Cleveland, Ohio, 44106-1716

  • Ohio State Cancer Center /ID# 200249

    Columbus, Ohio, 43210

  • Baylor University Medical Ctr. /ID# 170056

    Dallas, Texas, 75246

  • Duke Cancer Center /ID# 129356

    Durham, North Carolina, 27710-3000

  • The John Theurer Cancer /ID# 200248

    Hackensack, New Jersey, 07601

  • Ingalls Memorial Hosp /ID# 205346

    Harvey, Illinois, 60426

  • Hattiesburg Clinic /ID# 201187

    Hattiesburg, Mississippi, 39401

  • University of Arkansas for Medical Sciences /ID# 170002

    Little Rock, Arkansas, 72205

  • Univ of Wisconsin Hosp/Clinics /ID# 200246

    Madison, Wisconsin, 53792-0001

  • Medical College of Wisconsin /ID# 205229

    Milwaukee, Wisconsin, 53226-3522

  • Yale University /ID# 203704

    New Haven, Connecticut, 06510

  • Tulane Cancer Center Clinic /ID# 204123

    New Orleans, Louisiana, 70112

  • University of Nebraska Medical Center /ID# 169158

    Omaha, Nebraska, 68198-6840

  • Mayo Clinic - Rochester /ID# 74994

    Rochester, Minnesota, 55905-0001

  • Mayo Clinic - Scottsdale /ID# 75808

    Scottsdale, Arizona, 85259-5452

  • Swedish Cancer Institute - Edmonds /ID# 170006

    Seattle, Washington, 98104

  • Avera Cancer Institute /ID# 204178

    Sioux Falls, South Dakota, 57105

  • Washington University-School of Medicine /ID# 76094

    St Louis, Missouri, 63110

Other trials in United States

France4 sites

  • Duplicate_CHU Grenoble - Hopital Michallon /ID# 126658

    Grenoble, 38043

  • CHRU Lille - Hopital Claude Huriez /ID# 74995

    Lille, Hauts-de-France, 59037

  • CHU de Nantes, Hotel Dieu -HME /ID# 75033

    Nantes, Pays de la Loire Region, 44000

  • CHRU Tours - Hopital Bretonneau /ID# 126639

    Tours, Indre-et-Loire, 37044

Other trials in France

Belgium3 sites

  • ZNA Stuivenberg /ID# 170067

    Antwerp, 2060

  • UZ Brussel /ID# 170711

    Jette, Brussels Capital, 1090

  • Duplicate_University Hospital Leuven /ID# 170715

    Leuven, 3000

Other trials in Belgium

Norway1 site

  • Ulleval, OUS /ID# 170707

    Oslo, 0450

Other trials in Norway

About this study

Official title: A Phase 1/2 Study Evaluating the Safety and Pharmacokinetics of ABT-199 in Subjects With Relapsed or Refractory Multiple Myeloma

The Phase 1 primary objectives of this study were to assess the safety profile, characterize pharmacokinetics (PK) and determine the dosing schedule, maximum tolerated dose (MTD), and recommended Phase 2 dose (RPTD) of ABT-199 (venetoclax) when administered in participants with relapsed or refractory multiple myeloma. This study also assessed the safety profile and PK of venetoclax in combination with dexamethasone in participants with t(11;14)-positive multiple myeloma.

The Phase 2 primary objective was to further evaluate the objective response rate (ORR) and very good partial response or better rate (VGPR+) in participants with t(11;14)-positive multiple myeloma.

Keywords
Relapsed multiple myeloma, Refractory multiple myeloma, Multiple myeloma, Relapsed/refractory multiple myeloma
Medical subject headings
Multiple Myeloma

What participants receive

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

  • VenetoclaxDrug

    Also called ABT-199, VENCLEXTA®

    Each dose of venetoclax was to be taken with approximately 240 mL of water. On days that pre-dose pharmacokinetic (PK) sampling was required, dosing was to occur in the morning at the clinic at approximately 0900 (± 1 hour) to facilitate PK sampling. Dose Escalation cohort participants were to take venetoclax within 30 minutes after the completion of a standard low-fat breakfast with approximately 240 mL of water on Cycle 2 Day 1. On all other dosing days, participants were instructed to take venetoclax orally QD within 30 minutes after the completion of a low-fat breakfast. Tablets were to be swallowed whole and must not have been broken, chewed, or crushed.

  • DexamethasoneDrug

    Tablets were administered by mouth per the dexamethasone prescribing information.

Study groups in NCT01794520
Study groupRoleWhat they receive
Phase 1: Venetoclax 300 mgExperimentalParticipants in the dose-escalation cohort received 300 mg of venetoclax daily on Days 1 -21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
Receives: Drug: Venetoclax
Phase 1: Venetoclax 600 mgExperimentalParticipants in the dose-escalation cohort received 600 mg of venetoclax daily on Days 1 -21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
Receives: Drug: Venetoclax
Phase 1: Venetoclax 900 mgExperimentalParticipants in the dose-escalation cohort received 900 mg of venetoclax daily on Days 1 -21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
Receives: Drug: Venetoclax
Phase 1: Venetoclax 1200 mgExperimentalParticipants in the dose-escalation cohort received 1200 mg of venetoclax daily on Days 1 -21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
Receives: Drug: Venetoclax
Phase 1 Safety Expansion: Venetoclax 1200 mgExperimentalParticipants in the safety expansion cohort received 1200 mg of venetoclax daily on Days 1 - 21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
Receives: Drug: Venetoclax
Phase 1 Combination: Venetoclax 800 mg/Dexamethasone 20 or 40 mgExperimentalParticipants with t(11;14) translocation multiple myeloma received daily venetoclax at a dose of 800 mg (no lead-in period) on Days 1- 21 of each cycle concomitant with weekly dexamethasone at a dose of 40 mg (20 mg for those aged ≥ 75 years).
Receives: Drug: Venetoclax; Drug: Dexamethasone
Phase 2 Expansion: Venetoclax 800 mg/Dexamethasone 20 or 40 mgExperimentalThe Phase 2 cohort further explored the efficacy of venetoclax in combination with dexamethasone in relapsed or refractory participants with t(11;14) translocation multiple myeloma. Participants received daily venetoclax at a dose of 800 mg (no lead-in period) on Days 1- 21 of each cycle concomitant with weekly dexamethasone at a dose of 40 mg (20 mg for those aged ≥ 75 years).
Receives: Drug: Venetoclax; Drug: Dexamethasone

What is being measured

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

  1. Number of Participants With Adverse Events

    An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events/treatment-emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity on or after the first dose of study drug.

    Measured: From first dose of study drug until 30 days following last dose of study drug (up to 2482 days)

  2. Phase 1: Maximum Observed Plasma Concentration (Cmax) of Venetoclax

    Cmax is the highest concentration that a drug achieves in the blood after administration in a dosing interval.

    Measured: Cycle 2, Day 1 at predose, 2, 4, 6, 8, and 24 hours postdose

  3. Phase 1: Time to Maximum Observed Plasma Concentration (Tmax) of Venetoclax

    Tmax is the the time at which the maximum plasma concentration (Cmax) is observed.

    Measured: Cycle 2, Day 1 at predose, 2, 4, 6, 8, and 24 hours postdose

  4. Phase 1: Area Under the Plasma Concentration-Time Curve Over Time From 0 to 24 Hours (AUC0-24) of Venetoclax

    AUC is a measure of how long and how much drug is present in the body after dosing.

    Measured: Cycle 2, Day 1 at predose, 2, 4, 6, 8, and 24 hours postdose (dose escalation cohort); (1200 mg dose): Cycle 2, Day 1 at predose (safety expansion cohort, 1200 mg dose)

  5. Phase 2: Overall Response Rate

    Overall response rate is defined as the percentage of participants with documented best overall response of Partial Response (PR) or better (PR, Very good partial response [VGPR], Complete response [CR], or Stringent complete response [sCR]) per 2016 standard International Myeloma Working Group (IMWG) criteria.

    Measured: Response was assessed at Cycle 2, Day 1, and on Day 1 of every cycle thereafter; estimated median time on follow-up was 31.7 months

  6. Phase 2: Very Good Partial Response Rate or Better

    The percentage of participants with documented best overall response of Very Good Partial Response (VGPR) or better (VGPR, Complete response [CR], or Stringent complete response [sCR]) per 2016 standard International Myeloma Working Group (IMWG) criteria was computed.

    Measured: Response was assessed at Cycle 2, Day 1, and on Day 1 of every cycle thereafter; estimated median time on follow-up was 31.7 months

Secondary outcomes (10)

  1. Phase 1: Overall Response Rate

    Overall response rate is defined as the percentage of participants with documented best overall response of Partial Response (PR) or better (PR, Very good partial response [VGPR], Complete response [CR], or Stringent complete response [sCR]) per 2011 International Myeloma Working Group (IMWG) criteria.

    Measured: Response was assessed at Cycle 2, Day 1, and on Day 1 of every cycle thereafter; estimated median time on follow-up was 8.1 months

  2. Time to Response (TTR)

    TTR is defined as the number of days from the date of first dose of study drug until the date of their first favorable response of Partial Response (PR) or better (PR, Very good partial response [VGPR], Complete response [CR], or Stringent complete response [sCR]) per 2011 International Myeloma Working Group (IMWG) criteria (Phase 1) or 2016 IMWG criteria (Phase 2). If a participant did not experience a favorable response, they were to be censored at the date of last adequate assessment. TTR was analyzed by Kaplan- Meier (K-M)\ methodology.

    Measured: Response was assessed at Cycle 2, Day 1, and on Day 1 of every cycle thereafter; Estimated median time on follow-up was 8.1 months for Phase 1 and 31.7 months for Phase 2

  3. Time to Progression (TTP)

    TTP is defined as the number of days from the date of first dose of study drug to the date of first documented disease progression or death due to multiple myeloma, whichever occurs first. TTP was analyzed by Kaplan- Meier (K-M) methodology.

    Measured: Estimated median duration of follow-up was 8.1 months for Phase 1 and 31.7 months for Phase 2

  4. Duration of Response

    DOR is defined as the number of days from the date of first response of Partial Response (PR) or better to the date of first documented disease progression or death due to multiple myeloma, whichever occurs first. DOR was analyzed by Kaplan- Meier (K-M) methodology.

    Measured: Assessed at Cycle 2, Day 1, and on Day 1 of every cycle thereafter; estimated median duration of follow-up was 8.1 months for Phase 1 and 31.7 months for Phase 2

  5. Phase 2: Progression-Free Survival (PFS)

    PFS is defined as the number of days from the date of the first dose of study treatment to the date of first documented disease progression or death due to any cause, whichever occurs first. PFS was analyzed by Kaplan-Meier methodology.

    Measured: Estimated median duration of follow-up was 31.7 months

  6. Phase 2: Overall Survival (OS)

    OS is defined as the number of days from the date of the first dose of study drug to the date of death due to any cause. If a participant was not known to have died, OS was censored at the last known alive date. The distribution of OS was estimated using Kaplan-Meier methodology.

    Measured: Estimated median duration of follow-up was 31.7 months

  7. Phase 2: Mean Change From Baseline in Brief Pain Inventory - Short Form (BPI-SF) Worst Pain

    The BPI-SF is a pain-specific measure developed to assess patient-reported severity (or intensity) of pain (4 items) and the impact of pain on daily functioning (7 items) in patients with cancer pain. The four pain severity items assess pain at its "worst in last 24 hours," "least in last 24 hours," "average," and "now" (current pain). For these items, participants are asked to rate their pain on an 11-point numeric rating scale with anchors of 0 (no pain) and 10 (pain as bad as you can imagine). The Worst Pain scores range from 0 to 10, with higher scores indicating severe pain. Negative changes from baseline indicate improvement.

    Measured: Baseline; Cycle 3, Day 1; Cycle 5, Day 1; Cycle 7, Day 1; Cycle 9, Day 1; Cycle 11, Day 1; Cycle 13, Day 1; Cycle 15, Day 1; Cycle 17, Day 1; Cycle 19, Day 1; Cycle 21, Day 1; Cycle 23, Day 1; Cycle 25, Day 1; Final visit

  8. Phase 2: Mean Change From Baseline in Physical Functioning Scale of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)

    The QLQ-C30 is a 30-item subject self-report questionnaire composed of both multi-item and single scales, including five functional scales (physical, role, emotional, social, and cognitive), three symptom scales (fatigue, nausea and vomiting, and pain), a global health status/quality of life scale, and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). For the Physical Functioning scale, participants rate five items on a four-point scale, with 1 as "not at all" and 4 as "very much." The Physical Functioning Scale scores range from 0 to 100 and were calculated per the EORTC QLQ-C30 Scoring Manual (3rd edition), version 3.0. A high scale score represents high/healthy level of functioning. Positive changes from baseline indicate improvement.

    Measured: Baseline; Cycle 3, Day 1; Cycle 5, Day 1; Cycle 7, Day 1; Cycle 9, Day 1; Cycle 11, Day 1; Cycle 13, Day 1; Cycle 15, Day 1; Cycle 17, Day 1; Cycle 19, Day 1; Cycle 21, Day 1; Cycle 23, Day 1; Cycle 25, Day 1; Final visit

  9. Phase 2: Mean Change From Baseline in Global Health Status/Quality of Life Scale of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)

    The QLQ-C30 is a 30-item subject self-report questionnaire composed of both multi-item and single scales, including five functional scales (physical, role, emotional, social, and cognitive), three symptom scales (fatigue, nausea and vomiting, and pain), a global health status/quality of life scale, and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). For the Global Health Status/Quality of Life scale, participants rate two items on a seven point scale, with 1 as "very poor" and 7 as "excellent." The Global Health Status/Quality of Life scale ranges from 0 to 100 and was calculated per the EORTC QLQ-C30 Scoring Manual (3rd edition), version 3.0. A high score for the global health status/QoL represents a high QoL. Positive changes from baseline indicate improvement.

    Measured: Baseline; Cycle 3, Day 1; Cycle 5, Day 1; Cycle 7, Day 1; Cycle 9, Day 1; Cycle 11, Day 1; Cycle 13, Day 1; Cycle 15, Day 1; Cycle 17, Day 1; Cycle 19, Day 1; Cycle 21, Day 1; Cycle 23, Day 1; Cycle 25, Day 1; Final visit

  10. Phase 2: Mean Change From Baseline in Patient Reported Outcomes Measurement Information System [PROMIS] Cancer Fatigue Short Form [SF] Score

    PROMIS Cancer Fatigue SF is a seven item questionnaire that assesses the impact and experience of fatigue over the past 7 days. All questions employ the following five response options: 1 = Not at all, 2 = A little bit, 3 = Somewhat, 4 = Quite a bit, and 5 = Very much. The total raw score is the sum of the responses to each question and is converted to a T-score. The T-score re-scales the total raw score to a standardized score with a mean of 50 and a standard deviation of 10. The [PROMIS] Cancer Fatigue Short Form [SF] 7a T-Scores range from 29.4 to 83.2, with higher scores indicating more fatigue. Negative changes from baseline indicate improvement.

    Measured: Baseline; Cycle 3, Day 1; Cycle 5, Day 1; Cycle 7, Day 1; Cycle 9, Day 1; Cycle 11, Day 1; Cycle 13, Day 1; Cycle 15, Day 1; Cycle 17, Day 1; Cycle 19, Day 1; Cycle 21, Day 1; Cycle 23, Day 1; Cycle 25, Day 1; Final visit

Timeline

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

  1. First posted20 Feb 2013 (estimated)
  2. Study start10 Oct 2012
  3. Primary completion29 Nov 2021
  4. Study completion29 Nov 2021

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 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
117 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01794520
Sponsor's protocol ID
M13-367
Other IDs
2012-000589-38
Status last verified
Mar 2023
First submitted
12 Oct 2012
Last updated
10 Apr 2023
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

Publications

  • Badawi M, Coppola S, Eckert D, Gopalakrishnan S, Engelhardt B, Doelger E, Huang W, Dobkowska E, Kumar S, Menon RM, Salem AH. Venetoclax in biomarker-selected multiple myeloma patients: Impact of exposure on clinical efficacy and safety. Hematol Oncol. 2024 Jan;42(1):e3222. doi: 10.1002/hon.3222. Epub 2023 Sep 23.

    PubMed 37740931

  • Kumar S, Kaufman JL, Gasparetto C, Mikhael J, Vij R, Pegourie B, Benboubker L, Facon T, Amiot M, Moreau P, Punnoose EA, Alzate S, Dunbar M, Xu T, Agarwal SK, Enschede SH, Leverson JD, Ross JA, Maciag PC, Verdugo M, Touzeau C. Efficacy of venetoclax as targeted therapy for relapsed/refractory t(11;14) multiple myeloma. Blood. 2017 Nov 30;130(22):2401-2409. doi: 10.1182/blood-2017-06-788786. Epub 2017 Oct 10.

    PubMed 29018077

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Venetoclax and Dexamethasone in people with Relapsed/Refractory Multiple Myeloma, run by AbbVie at 29 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 22 inclusion and 12 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: finished, as of the sponsor's last update on 10 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 29 sites in United States, France, Belgium, Norway. 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Yes. Results are posted in the registry (first posted 10 Apr 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Participants With Adverse Events (time frame: From first dose of study drug until 30 days following last dose of study drug (up to 2482 days)). The study lists 6 primary outcomes in all. 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 NCT01794520, which also lists 2 linked publications.

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 10 Apr 2023; AzTrials last refreshed its copy on 30 Oct 2026.

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