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Proteasome Inhibitor
Combination Therapy for Multiple Myeloma
Phase 2
Waitlist Available
Research Sponsored by AbbVie
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participant has relapsed or refractory multiple myeloma with documented evidence of progression that occurred during or after the participant's last treatment regimen based on investigator's determination of International Myeloma Working Group (IMWG) criteria
Measurable disease confirmed by central lab at Screening, defined by at least 1 of the following: Serum M-protein >= 1.0 g/dL (>= 10 g/L), OR Urine M-protein >= 200 mg/24 hours, OR Serum free light chain (FLC) >= 10 mg/dL, provided serum FLC ratio is abnormal in participants who do not have measurable disease by Serum Protein Electrophoresis (SPEP) or Urine Protein Electrophoresis (UPEP) criteria
Must not have
Previous treatment with venetoclax or other B-Cell Lymphoma 2 (BCL-2) inhibitor
Previous treatment with daratumumab or other anti-CD38 therapy for participants in Parts 1 and 2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 months after confirmation of complete response (cr) or stringent complete response (scr)
Awards & highlights
No Placebo-Only Group
Summary
This trial is studying a combination of drugs as a potential treatment for relapsed or refractory multiple myeloma. The drugs involved are venetoclax, daratumumab, dexamethasone, and bortezomib. The study will consist of three parts, with each part investigating a different combination of drugs. The first two parts are non-randomized, while the third part is randomized.
Who is the study for?
This trial is for adults with relapsed or refractory multiple myeloma, specifically those who have measurable disease and have undergone previous treatments. Participants must be t(11;14) positive for certain parts of the study and should have good blood, kidney, and liver function. People with recent high-dose steroid use, central nervous system involvement by myeloma, significant medical conditions, other active cancers in the last 3 years (with exceptions), allergies to study drugs or their components, prior BCL-2 inhibitor or anti-CD38 therapy (for some parts), or active COVID-19 are excluded.
What is being tested?
The trial tests combinations of venetoclax with daratumumab and dexamethasone—with or without bortezomib—to assess safety and effectiveness in treating multiple myeloma that has come back or hasn't responded to treatment. It's divided into three parts: two non-randomized phases exploring different drug combos at increasing doses followed by an expansion phase; the third part randomly assigns patients to one of two treatment groups.
What are the potential side effects?
Potential side effects include nausea, diarrhea, low blood cell counts leading to increased infection risk or bleeding problems, fatigue, nerve damage causing numbness or pain (from bortezomib), allergic reactions during infusion of monoclonal antibodies like daratumumab. Each patient may experience side effects differently.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My multiple myeloma has worsened or not responded to my last treatment.
Select...
My cancer can be measured by specific blood or urine tests.
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My bone marrow samples have been collected.
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My cancer is t(11;14) positive according to a specific lab test.
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I can take care of myself but might not be able to do heavy physical work.
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My blood, kidney, and liver functions are all within normal ranges.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have been treated with venetoclax or a similar drug before.
Select...
I have been treated with daratumumab or another anti-CD38 therapy.
Select...
My condition did not improve after proteasome inhibitor treatment.
Select...
My multiple myeloma has spread to my brain.
Select...
I currently have an active severe COVID-19 infection.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 12 months after confirmation of complete response (cr) or stringent complete response (scr)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 months after confirmation of complete response (cr) or stringent complete response (scr)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Complete Response (CR) or Better Rate
Duration of Response (DOR)
Overall Response Rate (ORR)
+5 moreSecondary study objectives
AUC0-24 of Venetoclax
Cmax of Venetoclax
Minimal Residual Disease (MRD)
+1 moreSide effects data
From 2022 Phase 3 trial • 389 Patients • NCT0200547133%
Neutropenia
11%
SARS-CoV-2 test positive
11%
Sepsis
11%
Abdominal pain
11%
Pneumonia
11%
Rhinovirus infection
11%
COVID-19
11%
Gastroenteritis
11%
Pneumonia pseudomonal
11%
Electrocardiogram QT prolonged
11%
Anaemia
11%
Neutrophil count decreased
11%
Hypokalaemia
11%
Febrile neutropenia
11%
Supraventricular tachycardia
11%
Blood creatinine increased
11%
White blood cell count decreased
11%
Dermatitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Bendamustine + Rituximab Crossover Substudy
Venetoclax + Rituximab Re-Treatment Substudy
Venetoclax + Rituximab Main Study
Bendamustine + Rituximab Main Study
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
7Treatment groups
Experimental Treatment
Active Control
Group I: Arm G: VenDd Dose ExpansionExperimental Treatment3 Interventions
Venetoclax at a pre-determined dose, administered orally QD in combination with daratumumab (1800 mg subcutaneous injection (preferred) or 16 mg/kg IV) administered in accordance with prescribing information and dexamethasone (oral or IV) 40 mg weekly (or 20 mg weekly, if necessary, as described in the protocol).
Group II: Arm F: VenDd Dose ExpansionExperimental Treatment3 Interventions
Venetoclax at a pre-determined dose, administered orally QD in combination with daratumumab (1800 mg subcutaneous injection (preferred) or 16 mg/kg IV) administered in accordance with prescribing information and dexamethasone (oral or IV) 40 mg weekly (or 20 mg weekly, if necessary, as described in the protocol).
Group III: Arm E, Part 2b: VenDVd Dose ExpansionExperimental Treatment4 Interventions
Venetoclax at dose determined by the dose-escalation phase, administered orally QD in combination with daratumumab (1800 mg subcutaneous injection (preferred) or 16 mg/kg IV) administered in accordance with prescribing information, bortezomib (1.3 mg/m2 subcutaneous injection) Cycles 1-8, Days 1, 4, 8 and 11, and dexamethasone (oral or IV) 20 mg Cycles 1 - 3, Days 1, 2, 4, 5, 8, 9, 11,12 and 15; 20 mg Cycles 4-8, Days 1,2,4,5,8,9,11 and 12; 40 mg weekly (or 20 mg weekly, if necessary as described in the protocol) Cycle 9+.
Group IV: Arm D, Part 2a: VenDVd Dose EscalationExperimental Treatment4 Interventions
Venetoclax at various doses administered orally QD in combination with daratumumab (1800 mg subcutaneous injection (preferred) or 16 mg/kg IV) administered in accordance with prescribing information, bortezomib (1.3 mg/m2 subcutaneous injection \[preferred\] or IV) Cycles 1-8, Days 1, 4, 8 and 11), and dexamethasone (oral or IV) 20 mg Cycles 1 - 3, Days 1, 2, 4, 5, 8, 9, 11,12 and 15; 20 mg Cycles 4-8, Days 1,2,4,5,8,9,11 and 12; 40 mg weekly (or 20 mg weekly, if necessary as described in the protocol) Cycle 9+.
Group V: Arm B, Part 1b: VenDd Dose ExpansionExperimental Treatment3 Interventions
Venetoclax at a dose determined by the dose-escalation phase, administered orally QD in combination with daratumumab (1800 mg subcutaneous injection (preferred) or 16 mg/kg IV) administered in accordance with prescribing information and dexamethasone (oral or IV) 40 mg weekly (or 20 mg weekly, if necessary, as described in the protocol).
Group VI: Arm A, Part 1a: VenDd Dose EscalationExperimental Treatment3 Interventions
Venetoclax (Ven) various doses administered orally, once daily (QD) in combination with daratumumab (D) (1800 mg subcutaneous injection (preferred) or 16 mg/kg intravenous \[IV\]) administered in accordance with prescribing information and dexamethasone (d) (oral or IV) 40 mg weekly (or 20 mg weekly, if necessary, as described in the protocol).
Group VII: Arm H: DVd DoseActive Control3 Interventions
Daratumumab (1800 mg subcutaneous injection (preferred) or 16 mg/kg IV) administered in accordance with prescribing information, bortezomib (1.3 mg/m2 subcutaneous injection) Cycles 1-8: Days 1, 4, 8 and 11, and dexamethasone (oral or IV) 20 mg on Cycles 1 - 3: Days 1, 2, 4, 5, 8, 9, 11,12 and 15; 40 mg weekly (or 20 mg weekly, if necessary as described in the protocol) on Cycles 4-8: Days 1,2,4,5,8,9,11 and 12; 20 mg monthly for Cycles 9+: Day 1
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Daratumumab
2014
Completed Phase 3
~2000
Venetoclax
2019
Completed Phase 3
~2240
Bortezomib
2005
Completed Phase 3
~1410
Dexamethasone
2007
Completed Phase 4
~2650
Find a Location
Who is running the clinical trial?
Janssen Research & Development, LLCIndustry Sponsor
1,004 Previous Clinical Trials
6,402,651 Total Patients Enrolled
76 Trials studying Multiple Myeloma
19,957 Patients Enrolled for Multiple Myeloma
AbbVieLead Sponsor
1,023 Previous Clinical Trials
520,158 Total Patients Enrolled
34 Trials studying Multiple Myeloma
4,909 Patients Enrolled for Multiple Myeloma
ABBVIE INC.Study DirectorAbbVie
444 Previous Clinical Trials
160,644 Total Patients Enrolled
14 Trials studying Multiple Myeloma
2,005 Patients Enrolled for Multiple Myeloma
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