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New treatment option for Multiple Myeloma in Relapse
Official title A Study of Venetoclax in Combination With Isatuximab and Dexamethasone for Relapsed/Refractory Multiple Myeloma
ClinicalTrials.gov ID: NCT06115135
What this study is testing
What is Venetoclax?
Venetoclax is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for multiple myeloma in relapse.
Also referred to as VENCLEXTA.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- A phase 2 study of venetoclax in combination with isatuximab and dexamethasone for relapsed/refractory multiple myeloma patients with t(11;14)
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Adults
You may be able to join if
- people must meet all the following to be eligible to enroll in this study. 1.Has a diagnosis of MM based on standard criteria as follows: Myeloma...
- 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...
- 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)
You likely can't join if
- people 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...
- Participant has a history of other active malignancies, including myelodysplastic syndrome (MDS), within the past 3 years prior to study entry, with...
- 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
See the full eligibility criteria
Who can join
- people must meet all the following 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...
- 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 \ 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...
- 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...
- 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...
- 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...
What rules you out
- people 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...
- 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...
- 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
- 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: a. Excluded: i. Anticancer therapies including chemotherapy, radiotherapy, or other investigational therapy, including targeted small...
- 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...
- 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...
- Additional: Warfarin, P-gp substrates, BCRP substrates, OATP1B1/1B3 substrates, P-gp inhibitors, BCRP inhibitors
The study team makes the final eligibility decision.
Where it's taking place
- West Hollywood, California, United States
- Omaha, Nebraska, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, not specified. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include West Hollywood, California, United States; Omaha, Nebraska, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.