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Multiple Myeloma in RelapsePhase 2NCT06115135

A Study of Venetoclax in Combination With Isatuximab and Dexamethasone for Relapsed/Refractory Multiple Myeloma

A Phase 2 study testing Venetoclax in people with Multiple Myeloma in Relapse and Multiple Myeloma, Refractory, run by Oncotherapeutics at 2 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

A phase 2 study of venetoclax in combination with isatuximab and dexamethasone for relapsed/refractory multiple myeloma patients with t(11;14) Read more about this study

Who is it for?
Any age
What is being tested?
Venetoclax
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
39 participants
Where
2 sitesUnited States
Study dates
20 Jun 2024to 31 Dec 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Subjects must meet all the following inclusion criteria to be eligible to enroll in this study.
  • 1.Has a diagnosis of MM based on standard criteria as follows: Myeloma Criteria: Must be At least 1 of 2
  • Clonal bone marrow plasma cells >10%
  • Biopsy-proven bony or extramedullary plasmacytoma
  • Active Myeloma criteria: Must Meet At Least ONE of the Following:
  • Meet at least one of the sub-criteria for #1 Evidence of End Organ Damage (a, b, c, or d), OR Meet sub-criteria #2. 60% or greater bone marrow plasma cells, OR Meet sub-criteria #3 Serum free light chain ratio, OR Meet sub-criteria #4 More than one focal lesion on MRI > 5mm in size.
Show all 21Show fewer
  • Evidence of end organ damage that can be attributed to the underlying plasma cell proliferative disorder, specifically
  • Hypercalcemia: serum calcium >0.25 mmol/L (>1mg/dL) higher than the upper limit of normal or >2.75 mmol/L (>11mg/dL)
  • Renal insufficiency: creatinine clearance <40 mL per minute or serum creatinine >177mol/L (>2mg/dL)
  • Anemia: hemoglobin value of >20g/L below the lowest limit of normal, or a hemoglobin value <100g/L
  • Bone lesions: one or more osteolytic lesions on skeletal radiography, CT, or PET/CT. If bone marrow has <10% clonal plasma cells, more than one bone lesion is required to distinguish from solitary plasmacytoma with minimal marrow involvement
  • 60% or greater clonal plasma cells on bone marrow examination
  • Serum involved / uninvolved free light chain ratio of 100 or greater, provided the absolute level of the involved light chain is at least 100 mg/L (a patient's involved free light chain either kappa or lambda is the one that is above the normal reference range; the uninvolved free light chain is the one that is typically in, or below, the normal range)
  • More than one focal lesion on MRI that is at least 5mm or greater in size The patient must have met the criteria for Active Myeloma at some stage following the diagnosis of Myeloma. Source documentation for both Myeloma and Active Myeloma will be required.
  • 2. Currently has MM with measurable disease, defined as:
  • a monoclonal immunoglobulin spike on serum electrophoresis of at least 0.5 g/dL and/or urine monoclonal protein levels of at least 200 mg/24 hours
  • for patients without measurable serum and urine M-protein levels, an involved SFLC > 100 mg/L or abnormal SFLC ratio
  • for patients with IgD MM, a monoclonal immunoglobulin IgD of at least 1500 mg/L or meet other measurable disease eligibility criteria
  • 3. Show the (11;14), as demonstrated by FISH or cytogenetic analysis at screening or at any point prior to screening. If performed more than 45 days prior, it should be repeated at the investigator's discretion.
  • 4. Absolute neutrophil count ≥ 1.5 x 109/L 5. Platelet count ≥ 75 x 109/L 6. Hemoglobin ≥ 8.0 g/dL within 21 days prior to enrollment. 7. Calculated or measured creatinine clearance (CrCl) of ≥ 30 mL/minute as calculated by Cockcroft-Gault method 8. Total bilirubin levels ≤ 2.0 mg/dL (normal levels) 9. AST (SGOT) and ALT (SGPT) ≤ 2 x ULN 10. Serum potassium 3.0-5.5 mEq/L 11. Female of childbearing potential (FCBP)† must have a negative serum or urine pregnancy test with a sensitivity of at least 25 mIU/mL within 10 - 14 days prior to and again within 24 hours of starting and must either commit to continued abstinence from heterosexual intercourse or use acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, and at least 28 days before she starts taking treatment drugs. FCBP must also agree to ongoing pregnancy testing. Men must agree to use a latex condom during sexual contact with a FCBP even if they have had a vasectomy. All subjects must be counseled at a minimum of every 28 days about pregnancy precautions and risks of fetal exposure. Contraception measures should be continued for 3 months following the treatment completion.
  • †A FCBP (female of childbearing potential) is a sexually mature woman who has not undergone a hysterectomy or bilateral oophorectomy; or has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months 12. Eastern Cooperative Oncology Group (ECOG) performance score less than or equal to 2 13. Participant must have received at least 1 prior line of therapy for multiple myeloma, including a proteasome inhibitor, lenalidomide, and glucocorticosteroids but not necessarily in one treatment regimen 14. Participant currently has documented progressive MM per IMWG criteria

Who cannot join

  • Subjects meeting any of the following exclusion criteria are not to be enrolled in the study:
  • Participant has a history of intolerability to any of the study drugs
  • Participant has any of the following conditions: amyloidosis, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), known human immunodeficiency viral (HIV) infection, active hepatitis B or C infection based on blood screen tests, significant cardiovascular disease, including uncontrolled angina, severe or uncontrolled arrhythmia, recent myocardial infarction within 6 months of screening, or congestive heart failure New York Heart Association (NYHA) Class greater than or equal to 3, Major surgery within 4 weeks prior to screening, acute infections requiring parenteral therapy (antibiotic, antifungal, or antiviral) within 14 days prior to screening, uncontrolled diabetes or uncontrolled hypertension within 14 days prior to screening, any other medical condition that, in the opinion of the Investigator, would adversely affect the participant's participation in the study
  • Participant has a history of other active malignancies, including myelodysplastic syndrome (MDS), within the past 3 years prior to study entry, with the following exceptions: previous malignancy with no evidence of disease confined and surgically resected (or treated with other modalities) with curative intent and unlikely to impact survival during the duration of the study
  • If participant had prior allogeneic stem cell transplant (SCT), participant has evidence of ongoing graft-versus-host disease (GvHD)
  • Participants that are pregnant or breast feeding
Show all 27Show fewer
  • Participants with hypersensitivity to any study medications and/or their excipients
  • Treatment with an anti-CD38 antibody (daratumumab or isatuximab) within the last 3 weeks
  • For those patients treated with an anti-CD38 antibody (daratumumab or isatuximab), alone or in combination, without achieving a best response of at least MR
  • Treatment with venetoclax
  • Treatment with any of the following prior to the first dose of study drug:
  • Chemotherapy within 3 weeks of starting study drugs
  • Corticosteroids (>20 mg per day prednisone or equivalent) within 3 weeks of starting study drugs
  • Immunotherapy, antibody therapy, immunomodulatory agents, or proteasome inhibitors within 3 weeks of starting study drugs
  • Extensive radiation therapy within 28 days of starting study drugs. Receipt of localized radiation therapy does not preclude enrollment
  • Use of any other experimental drug or therapy within 28 days of starting study drugs
  • Moderate or strong cytochrome P450 3A (CYP3A) inhibitors or inducers within 7 days of starting study drugs
  • Administration or consumption of any of the following within 3 days prior to the first dose of study drug:
  • Grapefruit or grapefruit products
  • Seville oranges (including marmalade containing Seville oranges)
  • Star fruit
  • Additional prior and concomitant therapy excluded and cautionary medications:
  • Excluded: i. Anticancer therapies including chemotherapy, radiotherapy, or other investigational therapy, including targeted small molecule agents: Excluded 5 half-lives prior to first dose and throughout venetoclax administration ii. Biologic agents (e.g., monoclonal antibodies) for anti-neoplastic intent: Excluded 21 days prior to first dose and throughout venetoclax administration
  • Cautionary during the study:
  • Strong and Moderate CYP3A inhibitors: Exclude during ramp-up phase and consider alternative medications. If the subject requires use of these medications at the cohort designated dose, use with caution and reduce the venetoclax dose by 50% for moderate inhibitors and at least 75% for strong inhibitors during co-administration. After discontinuation of CYP3A inhibitor, wait for 2 to 3 days before venetoclax dose is increased back to the initial maintenance/target dose.
  • Strong and Moderate CYP3A inducers: Exclude during ramp-up phase and consider alternative medications. If the subject requires use of these medications at the cohort designated dose, use with caution and contact medical monitor for guidance.
  • Additional: Warfarin, P-gp substrates, BCRP substrates, OATP1B1/1B3 substrates, P-gp inhibitors, BCRP inhibitors

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Richard Bailey contact

(310) 464-2190

rbailey@oncotherapeutics.com

Yohana Sebhat contact

310-810-3158

ysebhat@oncotherapeutics.com

United States2 sites, 2 recruiting

  • Nebraska Cancer Specialists

    Omaha, Nebraska, 68130

    Ashley Servais, MPH, 402-955-2691, aservais@nebraskacancer.com

    Joel Michalski, MD, PhD

    Recruiting

  • Berenson Cancer Center

    West Hollywood, California, 90069

    Marceya Soto, 310-623-1218, msoto@berensoncancercenter.com

    Victor Tellez, 310-623-1218, vtellez@berensoncancercenter.com

    Recruiting

Other trials in United States

About this study

Official title: A Phase 2 Study of Venetoclax in Combination With Isatuximab and Dexamethasone for Relapsed/Refractory Multiple Myeloma Patients With t(11;14)

A phase 2 study of venetoclax in combination with isatuximab and dexamethasone for relapsed/refractory multiple myeloma patients with t(11;14)

Read the detailed description

Despite recent advances in treating MM that have improved outcomes, patients with this B-cell malignancy inevitably become refractory to therapy, and thus, must rely on additional treatment options for long-term management of their disease.

Venetoclax is an oral BCL-2 inhibitor which has been recently demonstrated to show clinical activity for the treatment of MM. The BCL-2 family of proteins are critical regulators of apoptosis which include both anti-apoptotic (e.g. BCL-2, MCL-1 and BCL-XL) and pro-apoptotic (e.g. BAK and BAX) elements. The upregulation of anti-apoptotic proteins has been reported for most cancers, but high BCL-2 levels have been especially prevalent in human lymphoid malignancies including chronic lymphocytic leukemia, for which venetoclax is currently indicated. BCL-2 is also overexpressed especially in the subset of MM patients with t(11;14) translocations, a cytogenetic abnormality found in approximately 20% of MM patients.

Venetoclax as a single agent has been shown to induce apoptosis not only in human MM cell lines and primary MM tumor cell samples, but also specifically in RRMM patients. Clinical activity with single-agent venetoclax was mostly limited to those with (11;14) translocations, with 12 of 14 responses occurring among patients with that cytogenetic marker in the single-agent clinical trial of this BCL-2 inhibitor for patients with RRMM (#NCT01794520) as reported by Kumar et al.7 Resistance to venetoclax as a single agent has been shown to be mediated by MCL-1, with low BCL-2/MCL-1 ratios indicating resistance and high ratios indicating an increased sensitivity to this BCL-2 inhibitor. Furthermore, MCL-1 silencing was shown to heighten sensitivity to BCL-2 inhibitors, and MM xenograft models co-expressing BCL-2 with MCL-1 were resistant to venetoclax.

The therapeutic landscape of MM has evolved even more with the discovery and validation of monoclonal antibodies in the treatment of MM. The first two monoclonal antibody-based therapies to show promising activity for treating MM patients were elotuzumab, which targets SLAMF7, and daratumumab, which targets CD38. A recent phase 1 study showed high response rates among RRMM patients with t(11;14) who were treated with daratumumab, dexamethasone and venetoclax.2 The most recent addition to the collection of the antibody-based therapies is a humanized IgG1 monoclonal antibody that binds selectively to a unique epitope on the human CD38 receptor, isatuximab (SAR-650984). A dose finding phase 2 trial of isatuximab as a single agent was well tolerated and showed clinical activity for heavily pre-treated patients with RRMM.3 Furthermore, a phase 1b study examining combination therapy consisting of isatuximab with lenalidomide and dexamethasone showed promising activity and good tolerability for heavily previously treated patients with RRMM. Based on the results of two phase 3 studies, the antibody has been FDA-approved in combination with pomalidomide or carfilzomib for treating RRMM patients.

Notably, the investigators reported two cases of patients with RRMM who achieved rapid complete remissions to therapy with venetoclax at low doses (100 mg) in combination with bortezomib, dexamethasone and the anti-CD38 antibody daratumumab after failing multiple treatment regimens including bortezomib, dexamethasone and daratumumab. The investigators have recently reported on a larger retrospective study of RRMM patients receiving this combination. The response rate was 80% among those harboring the t(11;14) marker whereas it was only 31% among those lacking this chromosomal translocation. Responses were observed among patients who failed prior anti-CD38 antibody treatments. These results suggest that low doses of venetoclax may help overcome resistance to other anti-MM agents for the treatment of RRMM patients especially those with the t(11;14) chromosomal marker. Therefore, in this phase 2 trial, The investigators will evaluate the safety and efficacy of isatuximab, venetoclax and dexamethasone for treating patients with RRMM and show the t(11;14) marker.

Being tested
Venetoclax
Keywords
Multiple Myeloma, MM, RRMM, 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 VENCLEXTA

    All subjects in Dose Level 0 will receive 1) venetoclax, PO, at 400 mg every day (QD) on Days 1-28 of a 28-day cycle, 2) dexamethasone 40 mg IV, once weekly on Days 1, 8, 15, and 22 of a 28-day cycle; and 3) isatuximab 10mg/kg, IV, on Days 1, 8, 15, and 22 of the first 28-day cycle, and then Days 1 and 15 during subsequent 28-day cycles.

Study groups in NCT06115135
Study groupRoleWhat they receive
open-labelExperimentalThis is a Phase 2, multicenter, open-label study evaluating the safety and efficacy of venetoclax in combination with isatuximab and dexamethasone among RRMM patients who show the t(11;14) marker and currently show PD and have received at least 3 prior lines of therapy for multiple myeloma. All subjects in Dose Level 0 will receive 1) venetoclax, PO, at 400 mg every day (QD) on Days 1-28 of a 28-day cycle, 2) dexamethasone 40 mg IV, once weekly on Days 1, 8, 15, and 22 of a 28-day cycle where day 8 and 22 doses may be administered PO; and 3) isatuximab 10mg/kg, IV, on Days 1, 8, 15, and 22 of the first 28-day cycle, and then Days 1 and 15 during subsequent 28-day cycles. The primary safety analysis will focus on determining the DLTs for the study regimen, and occurrence of AEs throughout the study.
Receives: Drug: Venetoclax

What is being measured

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

  1. Incidence of Treatment-Emergent Adverse Events [Safety]

    Safety will be measured by counting the occurrence of adverse events throughout the study, graded via Common Terminology Criteria for Adverse Events (CTCAE) v 5.0 criteria

    Measured: [Time Frame: 54 months]

  2. Overall response rate (ORR) as a measure of efficacy

    To assess the overall response rate (ORR = CR + VGPR + PR)

    Measured: [Time Frame: 54 months]

  3. Clinical benefit rate (CBR) as a measure of efficacy

    (CBR = CR + VGPR + PR + MR)

    Measured: [Time Frame: 54 months]

Secondary outcomes (5)

  1. Assessment of the time to progression as a measure of efficacy (TTP)

    Time to progression, defined as the time (in months) from the initiation of therapy to progressive disease.Time to progression, defined as the time (in months) from the initiation of therapy to progressive disease.

    Measured: [Time Frame: 54 months]

  2. Progression Free Survival (PFS)

    Progression-free survival will be measured in months as the time from initiation of therapy to progressive disease or death from any cause, whichever occurs first

    Measured: [Time Frame: 54 months]

  3. Time to first response (TTFR)

    Time to first response (TTFR), defined as the time from the initiation of therapy to the first evidence of confirmed clinical benefit defined as > MR including patients who achieved a CR, VGPR, PR, or MR

    Measured: [Time Frame: 54 months]

  4. Duration of response (DOR)

    Duration of response, defined as the time (in months) from the first response to progressive disease

    Measured: [Time Frame: 54 months]

  5. Overall survival (OS)

    Overall survival, defined as the time (in months) from initiation of therapy to death from any cause or last follow-up visit

    Measured: [Time Frame: 54 months]

Timeline

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

  1. First posted2 Nov 2023
  2. Study start20 Jun 2024
  3. Primary completion30 Apr 2026 (estimated)
  4. Study completion31 Dec 2027 (estimated)

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
39 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06115135
Sponsor's protocol ID
BCC-VID-2022
Status last verified
Jan 2025
First submitted
11 Aug 2023
Last updated
16 Jan 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Kumar SK, Rajkumar SV, Dispenzieri A, Lacy MQ, Hayman SR, Buadi FK, Zeldenrust SR, Dingli D, Russell SJ, Lust JA, Greipp PR, Kyle RA, Gertz MA. Improved survival in multiple myeloma and the impact of novel therapies. Blood. 2008 Mar 1;111(5):2516-20. doi: 10.1182/blood-2007-10-116129. Epub 2007 Nov 1.

    PubMed 17975015

  • Bahlis NJ, Baz R, Harrison SJ, Quach H, Ho SJ, Vangsted AJ, Plesner T, Moreau P, Gibbs SD, Coppola S, Yang X, Al Masud A, Ross JA, Bueno O, Kaufman JL. Phase I Study of Venetoclax Plus Daratumumab and Dexamethasone, With or Without Bortezomib, in Patients With Relapsed or Refractory Multiple Myeloma With and Without t(11;14). J Clin Oncol. 2021 Nov 10;39(32):3602-3612. doi: 10.1200/JCO.21.00443. Epub 2021 Aug 13.

    PubMed 34388020

  • Touzeau C, Le Gouill S, Mahe B, Boudreault JS, Gastinne T, Blin N, Caillon H, Dousset C, Amiot M, Moreau P. Deep and sustained response after venetoclax therapy in a patient with very advanced refractory myeloma with translocation t(11;14). Haematologica. 2017 Mar;102(3):e112-e114. doi: 10.3324/haematol.2016.160408. Epub 2017 Jan 5. No abstract available.

    PubMed 28057737

  • Martin T, Baz R, Benson DM, Lendvai N, Wolf J, Munster P, Lesokhin AM, Wack C, Charpentier E, Campana F, Vij R. A phase 1b study of isatuximab plus lenalidomide and dexamethasone for relapsed/refractory multiple myeloma. Blood. 2017 Jun 22;129(25):3294-3303. doi: 10.1182/blood-2016-09-740787. Epub 2017 May 8.

    PubMed 28483761

  • Attal M, Richardson PG, Rajkumar SV, San-Miguel J, Beksac M, Spicka I, Leleu X, Schjesvold F, Moreau P, Dimopoulos MA, Huang JS, Minarik J, Cavo M, Prince HM, Mace S, Corzo KP, Campana F, Le-Guennec S, Dubin F, Anderson KC; ICARIA-MM study group. Isatuximab plus pomalidomide and low-dose dexamethasone versus pomalidomide and low-dose dexamethasone in patients with relapsed and refractory multiple myeloma (ICARIA-MM): a randomised, multicentre, open-label, phase 3 study. Lancet. 2019 Dec 7;394(10214):2096-2107. doi: 10.1016/S0140-6736(19)32556-5. Epub 2019 Nov 14.

    PubMed 31735560

  • Moreau P, Dimopoulos MA, Mikhael J, Yong K, Capra M, Facon T, Hajek R, Spicka I, Baker R, Kim K, Martinez G, Min CK, Pour L, Leleu X, Oriol A, Koh Y, Suzuki K, Risse ML, Asset G, Mace S, Martin T; IKEMA study group. Isatuximab, carfilzomib, and dexamethasone in relapsed multiple myeloma (IKEMA): a multicentre, open-label, randomised phase 3 trial. Lancet. 2021 Jun 19;397(10292):2361-2371. doi: 10.1016/S0140-6736(21)00592-4. Epub 2021 Jun 4.

    PubMed 34097854

  • Rahbari KJ, Nosrati JD, Spektor TM, Berenson JR. Venetoclax in Combination With Bortezomib, Dexamethasone, and Daratumumab for Multiple Myeloma. Clin Lymphoma Myeloma Leuk. 2018 Sep;18(9):e339-e343. doi: 10.1016/j.clml.2018.06.003. Epub 2018 Jun 18. No abstract available.

    PubMed 30033209

  • Regidor B, Goldwater MS, Wang J, Bujarski S, Swift R, Eades B, Emamy-Sadr M, Eshagian S, Schwartz G, Spektor TM, Berenson JR. Low dose venetoclax in combination with bortezomib, daratumumab, and dexamethasone for the treatment of relapsed/refractory multiple myeloma patients-a single-center retrospective study. Ann Hematol. 2021 Aug;100(8):2061-2070. doi: 10.1007/s00277-021-04555-3. Epub 2021 May 14.

    PubMed 33987683

  • Smith ML, Newland AC. Treatment of myeloma. QJM. 1999 Jan;92(1):11-4. doi: 10.1093/qjmed/92.1.11.

    PubMed 10209667

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Venetoclax in people with Multiple Myeloma in Relapse and Multiple Myeloma, Refractory, run by Oncotherapeutics at 2 sites in United States.

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 21 inclusion and 27 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: looking for participants now, as of the sponsor's last update on 16 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. 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?

This study is still under way. Results are not available in the source record yet.

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

Contact Richard Bailey ((310) 464-2190, rbailey@oncotherapeutics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Treatment-Emergent Adverse Events [Safety] (time frame: [Time Frame: 54 months]). The study lists 3 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 NCT06115135, which also lists 9 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 16 Jan 2025.

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