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Tests treatment safety and results for Multiple Myeloma
Official title A Study to Investigate the Safety and Efficacy of Belantamab for the Treatment of Multiple Myeloma When Used as Monotherapy and in Combination Treatments
ClinicalTrials.gov ID: NCT05714839
What this study is testing
What is Unconjugated belantamab antibody?
Unconjugated belantamab antibody is an investigational medicine, being studied as a potential treatment for multiple myeloma.
Also referred to as GSK2857914.
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
- The study consists of three parts: Part 1 The primary purpose of this part aims to evaluate the safety, tolerability, and clinical activity of escalating doses of single agent Unconjugated belantamab antibody in participants with refractory multiple myeloma (RRMM) who have received at least 3 prior therapies (4L+). Part 2 The primary purpose of this part is to evaluate the safety, tolerability, and clinical activity of different doses of unconjugated belantamab antibody in combination with a fixed dose of Belantamab mafodotin (delivered as separate drugs) in participants with RRMM who have received at least 3 prior therapies (4L+).
- 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
Ages 18 and older
You may be able to join if
- Participants at the time of signing the Informed Consent Form (ICF) are at least 18 years old or are of the legal age of consent in the jurisdiction...
- Participants who have histologically or cytologically confirmed diagnosis of Multiple Myeloma (MM), as defined by the international myeloma working...
- Part 1 and Part 2: Participants who have received at least 3 prior lines of anti-myeloma treatments, including lenalidomide, a proteasome inhibitor...
- Part 3: Have received at least 1 prior line of treatment anti-myeloma treatments, including lenalidomide. Prior anti-CD38-containing regimen is not...
- Participants with a history of Autologous stem cell transplant (ASCT) are eligible for study participation provided the following eligibility...
You likely can't join if
- Diagnosis of primary Amyloid Light chain (AL) Amyloidosis, active Polyneuropathy, organomegaly, endocrinopathy, myeloma protein, and skin changes...
- Part 3: Active or history of venous or arterial thromboembolism within the past 3 months. Contraindications to or unwilling to undergo...
- Any serious and/or unstable pre-existing medical, psychiatric disorder, or other conditions (including lab abnormalities) that could interfere with...
- Participant is exhibiting signs of meningeal or central nervous system involvement with MM.
- Current corneal epithelial disease except nonconfluent Superficial punctate keratitis (SPK).
- Has cirrhosis or current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy...
See the full eligibility criteria
Who can join
- Participants at the time of signing the Informed Consent Form (ICF) are at least 18 years old or are of the legal age of consent in the jurisdiction in which the study is taking place.
- Participants who have histologically or cytologically confirmed diagnosis of Multiple Myeloma (MM), as defined by the international myeloma working group (IMWG) and have progressed on or following the last line of...
- Part 1 and Part 2: Participants who have received at least 3 prior lines of anti-myeloma treatments, including lenalidomide, a proteasome inhibitor, and an anti-CD38 mAb (either in combination or separately.
- Part 3: Have received at least 1 prior line of treatment anti-myeloma treatments, including lenalidomide. Prior anti-CD38-containing regimen is not mandated, however no more than 70% of participants recruited may be...
- Participants with a history of Autologous stem cell transplant (ASCT) are eligible for study participation provided the following eligibility criteria are met:
- transplant was greater than (\>)100 days prior to screening.
- No active bacterial, viral, or fungal infection(s) present
- Eastern cooperative oncology group-performance status (ECOG-PS) of 0 to 2.
- Measurable disease defined as at least ONE of the following:
- Serum M-protein concentration greater than or equal to (\>=) 0.5 gram (g)/ deciliter (dL) (\>=5 gram/liter [g/L])
- Urine M-protein excretion \>=200 mg/24 hours (\>=0.2 g/24 hours)
- Serum free light chain (FLC) assay: involved FLC level \>=10 mg/dL (\>=100 milligrams per liter [mg/L]) and an abnormal serum FLC ratio (less than [\ 1.65)
- Have adequate organ system function as defined by the laboratory assessments
- All prior treatment-related toxicities (defined by National Cancer Institute-Common Toxicity Criteria for Adverse Events [NCI-CTCAE], v5.0, 2017) must be Grade less than or equal to (\<=)1 at the time of screening...
- Participants or legally authorized representative (LAR) (if applicable per local regulation) capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF...
- Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:
- Is NOT a Participant of child-bearing potential (POCBP) or
- Is a POCBP and using a contraceptive method that is highly effective (with a failure rate of \<1% per year), preferably with low user dependency during the intervention period and for 4 months after the last dose of...
- Part 3: Due to pomalidomide being a thalidomide analogue with a risk for embryofetal toxicity and prescribed under a pregnancy prevention/controlled distribution program, POCBP will be eligible if they commit either to...
- The investigator should evaluate the how well it works of the contraceptive method in relationship to the first dose of study intervention
- All POCBP must agree not to donate eggs (ova, oocytes) for the purpose of reproduction during this period.
What rules you out
- Diagnosis of primary Amyloid Light chain (AL) Amyloidosis, active Polyneuropathy, organomegaly, endocrinopathy, myeloma protein, and skin changes (POEMS) syndrome, primary plasma cell leukemia.
- Part 3: Active or history of venous or arterial thromboembolism within the past 3 months. Contraindications to or unwilling to undergo protocol-required anti-thrombotic prophylaxis
- Any serious and/or unstable pre-existing medical, psychiatric disorder, or other conditions (including lab abnormalities) that could interfere with participant's safety, obtaining informed consent, or compliance with...
- Participant is exhibiting signs of meningeal or central nervous system involvement with MM.
- Current corneal epithelial disease except nonconfluent Superficial punctate keratitis (SPK).
- Has cirrhosis or current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal/gastric varices, or persistent...
- Presence of malignancies other than disease under study are excluded, except for any other malignancy from which the participant has been disease-free for more than 2 years and, in the opinion of the Principal...
- Evidence of cardiovascular risk including any of the following:
- Evidence of current clinically significant untreated arrhythmias, including, but not limited to, clinically significant Electrocardiogram (ECG) abnormalities such as 2nd degree (Mobitz Type II) or 3rd degree...
- Part 1 dose escalation and Part 2 only: QT interval corrected using Fridericia's formula (QTcF) interval \>480 millisecond (msec) (QT interval corrected for heart rate according to Fridericia's formula), and/or...
- Part 1 dose expansion and Part 3: Not applicable.
- History of MI, acute coronary syndromes (including unstable angina), coronary angioplasty, stenting or bypass grafting, all within three months of screening.
- Class III or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system.
- Uncontrolled hypertension
- Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to Unconjugated belantamab antibody / belantamab mafodotin or any of the components of the study treatment. History of...
- Active infection requiring antibiotic, antiviral, or antifungal treatment.
- For serology of Hepatitis B surface antigen (HBsAg)+ at screen or within 3 months prior to first dose Japan only: must test Hepatitis B e antigen (HBeAg) and Hepatitis B e antibody (HBeAb). Eligibility verification...
- Known Human immunodeficiency virus (HIV) infection, unless the participant can meet specific criteria.
- Recent history (within the past 6 months) of acute diverticulitis, inflammatory bowel disease, intra-abdominal abscess, or gastrointestinal obstruction.
- Participants with Hepatitis B virus (HBV) or Hepatitis C virus (HCV) will be excluded unless specific criteria can be met.
- Presence of active renal condition (infection, requirement for dialysis or any other condition that could affect participant's safety). Participants with isolated proteinuria resulting from MM are eligible.
- Part 1: Refractory to belantamab mafodotin (confirmed PD as per IMWG criteria while on belantamab mafodotin therapy or within 60 days of completing that treatment). Prior belantamab mafodotin is allowed if it was...
- Part 2: Prior belantamab mafodotin therapy is not allowed. Prior treatment with other anti-BCMA directed agents is allowed provided there is at least a 6-month washout after the last dose of prior anti-BCMA therapy to...
- Prior radiotherapy within 2 weeks of start of study therapy.
- Plasmapheresis within 7 days prior to the first dose of study drug.
- Prior allogeneic stem cells transplant.
- Participants who have received prior Chimeric Antigen Receptor T-cell therapy (CAR-T) therapy with lymphodepletion with chemotherapy within 3 months of screening.
- Any major surgery (other than bone-stabilizing surgery) within 2 weeks of first dose or has not recovered fully from surgery.
- Prior treatment with a mAb within 30 days of receiving the first dose of study drugs, or treatment with an investigational agent or approved systemic anti-myeloma therapy (including systemic steroids) within 14 days or...
- Part 1 dose escalation only: Has received transfusion of blood products (including platelets or red blood cells) or administration of colony stimulating factors (including Granulocyte colony stimulating factor (G-CSF)...
- Part 3: Prior Unconjugated belantamab antibody, belantamab mafodotin, and pomalidomide therapy are not allowed. Prior treatment with other anti- BCMA directed agents is allowed provided there is at least 6-month washout...
- Participants must not receive live/live attenuated vaccines within 30 days prior to first dose of study treatment or whilst receiving Unconjugated belantamab antibody for at least 70 days following last study treatment.
- Is or has an immediate family member (e.g., spouse, parent/legal guardian, sibling, or child) who is investigational site or Sponsor staff directly involved with this trial, unless prospective Independent Review Board...
- The use of other anti-cancer therapy not specified in this protocol, and any investigational agents other than unconjugated belantamab and belantamab mafodotin, or any other MM Standard of Care (SoC) agents other than...
The study team makes the final eligibility decision.
Where it's taking place
- Bullhead City, Arizona, United States
- Pembroke Pines, Florida, United States
- Grand Rapids, Michigan, United States
- Chapel Hill, North Carolina, United States
- Wilson, North Carolina, United States
- Canton, Ohio, United States
- Chattanooga, Tennessee, United States
- Nashville, Tennessee, United States
- Ciudadela, Argentina
- Rosario, Argentina
- San Juan Bautista, Argentina
- Viedma, Argentina
- Fitzroy, Victoria, Australia
- Nedlands, Western Australia, Australia
- Joinville, Brazil
- Salvador, Brazil
- São Paulo, Brazil
- Jerusalem, Israel
- Aomori, Japan
- Chiba, Japan
+ 15 more site(s).
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, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bullhead City, Arizona, United States; Pembroke Pines, Florida, United States; Grand Rapids, Michigan, United States; Chapel Hill, North Carolina, United States; Wilson, North Carolina, United States; Canton, Ohio, United States and 29 more location(s). 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.