Multiple MyelomaPhase 1/2DynaMMic-1NCT05714839
A Study to Investigate the Safety and Efficacy of Belantamab for the Treatment of Multiple Myeloma When Used as Monotherapy and in Combination Treatments
A Phase 1/2 study testing Belantamab, Belantamab mafodotin and Pomalidomide in people with Multiple Myeloma, run by GlaxoSmithKline at 44 sites in 13 countries.
Trial summary
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 belantamab in participants with refractory multiple myeloma (RRMM) who have received at least 3 prior therapies (4L+). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Belantamab, Belantamab mafodotin and Pomalidomide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 123 participants
- Where
- 44 sitesin 13 countries
- Study dates
- 14 Jun 2023to 3 Aug 2028
- Phase
- Phase 1/2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to 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 treatment
- Part 1 and Part 2: Participants who have received at least 3 prior lines of anti-myeloma treatments, including any immunomodulatory drug (IMiDs lenalidomide, pomalidomide or thalidomide), a proteasome inhibitor, and an anti-CD38 monoclonal antibodies (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 anti-CD38 naïve.
- 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.
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- 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 milligram (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 [<]0.26 or >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 except for alopecia (any grade), neuropathy (Grade <=2), or endocrinopathy managed with replacement therapy (any grade).
- 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 and in this protocol.
- Male Participants (for parts 1b, 2 and 3):
- Contraceptive use by men should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Male Participants enrolled in part 1 (and expansion) cohort receiving belantamab monotherapy are not required to use contraception
- Male participants are eligible to participate in parts 2 and 3 if they agree to the following during the intervention period and for at least 6 months after the last dose of study intervention to allow for clearance of any altered sperm:
- Refrain from donating fresh unwashed semen PLUS either:
- Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent OR
- Must agree to use contraception/barrier as detailed below
- Agree to use a male condom, even if they have undergone a successful vasectomy, and female partner to use an additional highly effective contraceptive method with a failure rate of <1 percent (%) per year when having sexual intercourse with POCBP who is not currently pregnant. Male participants should also use a condom when having sexual intercourse with pregnant females.
- 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, 30 days prior to treatment start, during the intervention period and for 4 months after the last dose of study intervention and agrees not to donate eggs (ova, oocytes) for the purpose of reproduction during this period. The investigator should evaluate the effectiveness of the contraceptive method in relationship to the first dose of study intervention.
- 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 abstain continuously from heterosexual sexual intercourse or use two methods of reliable birth control (one method that is highly effective plus an additional barrier method), beginning at least 4 weeks prior to initiating treatment with pomalidomide, during therapy, during dose interruptions and continuing for at least 4 weeks following discontinuation of pomalidomide treatment. Thereafter, POCBP must use one contraceptive method that is highly effective (with a failure rate of less than (<)1% per year) for a further 3 months (total 4 months).
- The investigator should evaluate the effectiveness 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.
Who cannot join
- 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 study procedures.
- Participant is exhibiting signs of meningeal or central nervous system involvement with MM.
- Part 2: 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 jaundice.
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- 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 investigator (PI) and GlaxoSmithKline (GSK) Medical Director, will not affect the evaluation of the effects of this clinical trial treatment on the currently targeted malignancy (MM). Participants on active surveillance or hormone treatment for non-metastatic prostate cancer are not excluded. Participants on hormone therapy for non-metastatic breast cancer are not excluded
- 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 Atrioventricular (AV) block.
- 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 hypokalemia, and/or family history of long QT syndrome.
- 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 belantamab / belantamab mafodotin or any of the components of the study treatment. History of severe hypersensitivity to other Monoclonal antibodies (mAbs).
- 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 should be evaluated and agreed with a hepatologist (after they record the approval in the participant medical record).
- 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 discontinued due to toxicity which subsequently resolved. Note: Prior treatment with other anti- B-cell maturation antigen (BCMA) directed agents is allowed. Provided there is at least 6-month washout after the last dose of prior anti-BCMA therapy.
- 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 .
- 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 5 half-lives of receiving the first dose of study drugs, whichever is longer.
- 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], Granulocyte-macrophage colony-stimulating factor [GMCSF], recombinant erythropoietin) or any thrombopoietin receptor agonists within 2 weeks before the first dose of study drug. This does not apply for Part 1 Expansion Cohort.
- Part 3: Prior belantamab, 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 after the last dose of prior anti-BCMA therapy.
- Participants must not receive live/live attenuated vaccines within 30 days prior to first dose of study treatment or whilst receiving belantamab 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 (IRB) approval (by chair or designee) is allowing exception to this criterion for a specific participant.
- The use of other anti-cancer therapy not specified in this protocol, and any investigational agents other than belantamab and belantamab mafodotin, or any other MM Standard of Care (SoC) agents other than pomalidomide or dexamethasone are explicitly prohibited for the duration of the study.
Trial locations and contacts
44 sites in 13 countries. Contact the study team or a site near you to ask about taking part.
44 sites in 13 countries
United States11 sites, 11 recruiting
- Recruiting
GSK Investigational Site
Boston, Massachusetts, 02215
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Bullhead City, Arizona, 86442
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Canton, Ohio, 44718
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Chapel Hill, North Carolina, 27514
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Chattanooga, Tennessee, 37404
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Fort Worth, Texas, 76104
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Grand Rapids, Michigan, 49546
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Los Angeles, California, 90027
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Nashville, Tennessee, 37203
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Pembroke Pines, Florida, 33024
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Wilson, North Carolina, 27893
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Japan6 sites, 5 recruiting
- Recruiting
GSK Investigational Site
Aomori, 030-8553
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Chiba, 277-8577
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Kanagawa, 221-0855
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Completed
GSK Investigational Site
Osaka, 545-8586
- Recruiting
GSK Investigational Site
Tokyo, 105-8471
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Yamagata, 990-9585
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Argentina5 sites, 4 recruiting
- Recruiting
GSK Investigational Site
Capital Federal, C1426ANZ
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Completed
GSK Investigational Site
Ciudadela, B1702
- Recruiting
GSK Investigational Site
Rosario, S2002
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
San Juan Bautista, B1888AAE
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Viedma, R8500ACE
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Brazil3 sites, 3 recruiting
- Recruiting
GSK Investigational Site
Joinville, 89201-260
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Salvador, 41253-190
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
São Paulo, 04537-080
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Israel3 sites, 3 recruiting
- Recruiting
GSK Investigational Site
Beersheba, 84101
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Jerusalem, 9112001
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Ramat Gan, 52621
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Taiwan3 sites, 3 recruiting
- Recruiting
GSK Investigational Site
Changhua, 500
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Kaohsiung City, 807
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Taipei, 100
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
United Kingdom3 sites, 2 recruiting
- Recruiting
GSK Investigational Site
Leicester, LE1 5WW
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Completed
GSK Investigational Site
Oxford, OX3 7LE
- Recruiting
GSK Investigational Site
Plymouth, PL6 8DH
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Australia2 sites, 1 recruiting
- Recruiting
GSK Investigational Site
Fitzroy, Victoria, 3065
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Completed
GSK Investigational Site
Nedlands, Western Australia, 6009
Poland2 sites, 1 recruiting
- Withdrawn
GSK Investigational Site
Gdansk, 80-214
- Recruiting
GSK Investigational Site
Lublin, 20-081
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
South Korea2 sites, 2 recruiting
- Recruiting
GSK Investigational Site
Seoul, 137-701
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Seoul, 138-736
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Turkey (Türkiye)2 sites, 2 recruiting
- Recruiting
GSK Investigational Site
Istanbul, 34010
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Kayseri, 38039
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
China1 site, 1 recruiting
- Recruiting
GSK Investigational Site
Suzhou
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
South Africa1 site, 1 recruiting
- Recruiting
GSK Investigational Site
Kuils River, Western Cape, 7580
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
About this study
Official title: A Phase 1/2 Open-label, Multicentre, Dose Escalation and Expansion Study to Investigate the Safety, Tolerability, and Clinical Activity of Belantamab as Monotherapy and in Combination With Other Treatments in Participants With Multiple Myeloma
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 belantamab 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 belantamab 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+).
- Part 3: The Primary purpose of this part will evaluate the clinical activity of a selected dose of the belantamab in combination with the pomalidomide-dexamethasone (Pd) standard of care (SoC) backbone. The study will focus on participants with multiple myeloma who have undergone at least one prior line of therapy, including treatment with lenalidomide.
- Conditions
- Multiple Myeloma
- Being tested
- Belantamab, Belantamab mafodotin, Pomalidomide, Dexamethasone
- Keywords
- Belantamab, Belantamab Mafodotin, Relapsed or Refractory Multiple Myeloma
- Medical subject headings
- Multiple Myeloma, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BelantamabDrug
Also called GSK2857914
Belantamab will be administered.
Belantamab mafodotinDrug
Also called GSK2857916
Belantamab mafodotin will be administered.
PomalidomideDrug
Pomalidomide will be administered.
DexamethasoneDrug
Dexamethasone will be administered.
| Study group | Role | What they receive |
|---|---|---|
| Part 1: Dose escalation and expansion of belantamab monotherapy | Experimental | Belantamab will be administered in participants with RRMM until progressive disease (PD) Receives: Drug: Belantamab |
| Part 2: Belantamab and belantamab mafodotin (delivered as separate drugs) dose range finding | Experimental | Participants with RRMM will receive belantamab and belantamab mafodotin Receives: Drug: Belantamab; Drug: Belantamab mafodotin |
| Part 3: Belantamab +pomalidomide/dexamethasone in 2L+ RRMM | Experimental | Participants with RRMM will receive belantamab in combination with pomalidomide-dexamethasone backbone. Receives: Drug: Belantamab; Drug: Pomalidomide; Drug: Dexamethasone |
| Part 1b: Optional belantamab mafodotin | Experimental | Participants enrolled in Part 1 and Part 2 will be dosed until PD after which they will have the option to receive treatment with single agent belantamab mafodotin. Receives: Drug: Belantamab mafodotin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parts 1, 2 and 3: Number of Participants with any Adverse Event
Measured: Up to 52 months
Part 1 (Dose escalation cohort) and Part 2: Number of Participants with Dose Limiting Toxicities (DLTs)
Measured: Cycle 1 (Each cycle is of 28 days)
Part 1, 2 and 3: Number of Participants with Worst Case Grade Change from Baseline in Laboratory and Vital Sign Parameters
Measured: Up to 52 months
Part 2: Number of Participants with severity of ocular events by the Keratopathy Visual Acuity (KVA) scale
Measured: Up to 52 months
Part 2: Overall Response Rate (ORR)
Measured: Up to 52 months
Part 3: Very Good Partial Response and better rate (VGPR+)
VGPR+ is defined as the percentage of participants with a confirmed VGPR or better (i.e., VGPR, complete response, stringent complete response).
Measured: Up to 52 months
Secondary outcomes (26)
Part 1: Overall Response Rate (ORR)
Measured: Up to 52 months
Part 1: Observed Plasma Concentration of belantamab
Measured: Up to 52 months
Part 1: Area Under the Curve (AUC) of belantamab
Measured: Up to 52 months
Part 1: Maximum Concentration (Cmax) of belantamab
Measured: Up to 52 months
Part 1: Number of Participants with Anti-Drug Antibodies (ADA) against belantamab
Measured: Up to 52 months
Part 1: Titers of ADA against belantamab
Measured: Up to 52 months
Part 2: Duration of Response (DoR)
Measured: Up to 52 months
Part 2: Observed Plasma Concentration of Total belantamab
Measured: Up to 52 months
Part 2: Area Under the Curve (AUC) of Total belantamab
Measured: Up to 52 months
Part 2: Maximum Concentration (Cmax) of Total belantamab
Measured: Up to 52 months
Part 2: Observed Plasma Concentration of belantamab mafodotin (ADC)
Measured: Up to 52 months
Part 2: Area Under the Curve (AUC) of belantamab mafodotin (ADC)
Measured: Up to 52 months
Part 2: Maximum Concentration (Cmax) of belantamab mafodotin (ADC)
Measured: Up to 52 months
Part 2: Observed Plasma Concentration of Cys-Monomethyl Auristatin-F (Cys-mcMMAF)
Measured: Up to 52 months
Part 2: Area Under the Curve (AUC) of Cys-mcMMAF
Measured: Up to 52 months
Part 2: Maximum Concentration (Cmax) of Cys-mcMMAF
Measured: Up to 52 months
Part 2: Number of Participants with ADAs against belantamab and belantamab mafodotin
Measured: Up to 52 months
Part 2: Titers of ADAs against belantamab and belantamab mafodotin
Measured: Up to 52 months
Part 3: Minimal residual disease (MRD) negativity rate in participants achieving at least VGPR
MRD negativity rate is defined as the percentage of participants who achieve MRD negative status at 10-5 sensitivity threshold assessed by next generation sequencing at least once during the time of confirmed VGPR+ response per International myeloma working group (IMWG) criteria.
Measured: Up to 52 months
Part 3: Overall Response Rate (ORR)
Measured: Up to 52 months
Part 3: Duration Of Response (DoR)
Measured: Up to 52 months
Part 3: Observed Plasma Concentration of Total belantamab
Measured: Up to 52 months
Part 3: Area Under the Curve (AUC) of Total belantamab
Measured: Up to 52 months
Part 3: Maximum Concentration (Cmax) of Total belantamab
Measured: Up to 52 months
Part 3: Number of Participants with ADAs against belantamab
Measured: Up to 52 months
Part 3: Titers of ADAs against belantamab
Measured: Up to 52 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2023
- Study start14 Jun 2023
- Primary completion3 Aug 2028 (estimated)
- Study completion3 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 123 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05714839
- Sponsor's protocol ID
- 218670
- Other IDs
- 2022-501941-63-00
- Acronym
- DynaMMic-1
- Status last verified
- Aug 2026
- First submitted
- 27 Jan 2023
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk-studyregister.com/gsk-patient-level-data-sharing-july2025.pdf
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2 Open-label, Multicentre, Dose Escalation and Expansion Study to Investigate the Safety, Tolerability, and Clinical Activity of Belantamab as Monotherapy and in Combination With Other Treatments in Participants With Multiple Myeloma
- ClinicalTrials.gov ID
- NCT05714839
- Acronym / sponsor ID
- DynaMMic-1 / 218670
- Conditions
- Multiple Myeloma
- Keywords
- Belantamab, Belantamab Mafodotin, Relapsed or Refractory Multiple Myeloma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 123 participants (estimated)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 14 Jun 2023 (actual)
- Primary completion
- 3 Aug 2028 (estimated)
- Study completion
- 3 Aug 2028 (estimated)
- First posted
- 6 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 belantamab 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 belantamab 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+).
- Part 3: The Primary purpose of this part will evaluate the clinical activity of a selected dose of the belantamab in combination with the pomalidomide-dexamethasone (Pd) standard of care (SoC) backbone. The study will focus on participants with multiple myeloma who have undergone at least one prior line of therapy, including treatment with lenalidomide.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Part 1: Dose escalation and expansion of belantamab monotherapy | Experimental | Drug: BelantamabBelantamab will be administered in participants with RRMM until progressive disease (PD) |
| Part 2: Belantamab and belantamab mafodotin (delivered as separate drugs) dose range finding | Experimental | Drug: Belantamab, Drug: Belantamab mafodotinParticipants with RRMM will receive belantamab and belantamab mafodotin |
| Part 3: Belantamab +pomalidomide/dexamethasone in 2L+ RRMM | Experimental | Drug: Belantamab, Drug: Pomalidomide, Drug: DexamethasoneParticipants with RRMM will receive belantamab in combination with pomalidomide-dexamethasone backbone. |
| Part 1b: Optional belantamab mafodotin | Experimental | Drug: Belantamab mafodotinParticipants enrolled in Part 1 and Part 2 will be dosed until PD after which they will have the option to receive treatment with single agent belantamab mafodotin. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (28 listed)
- 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 treatment
- Participants with a history of Autologous stem cell transplant (ASCT) are eligible for study participation provided the following eligibility criteria are met:
- Eastern cooperative oncology group-performance status (ECOG-PS) of 0 to 2.
- Measurable disease defined as at least ONE of the following:
Key exclusion criteria (34 listed)
- 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 study procedures.
- Participant is exhibiting signs of meningeal or central nervous system involvement with MM.
- Part 2: Current corneal epithelial disease except nonconfluent Superficial punctate keratitis (SPK).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BelantamabAlso: GSK2857914Belantamab will be administered. | Drug | Part 1: Dose escalation and expansion of belantamab monotherapy, Part 2: Belantamab and belantamab mafodotin (delivered as separate drugs) dose range finding, Part 3: Belantamab +pomalidomide/dexamethasone in 2L+ RRMM |
| Belantamab mafodotinAlso: GSK2857916Belantamab mafodotin will be administered. | Drug | Part 1b: Optional belantamab mafodotin, Part 2: Belantamab and belantamab mafodotin (delivered as separate drugs) dose range finding |
| PomalidomidePomalidomide will be administered. | Drug | Part 3: Belantamab +pomalidomide/dexamethasone in 2L+ RRMM |
| DexamethasoneDexamethasone will be administered. | Drug | Part 3: Belantamab +pomalidomide/dexamethasone in 2L+ RRMM |
Primary outcome
Parts 1, 2 and 3: Number of Participants with any Adverse Event
Time frame: Up to 52 months
Part 1 (Dose escalation cohort) and Part 2: Number of Participants with Dose Limiting Toxicities (DLTs)
Time frame: Cycle 1 (Each cycle is of 28 days)
Part 1, 2 and 3: Number of Participants with Worst Case Grade Change from Baseline in Laboratory and Vital Sign Parameters
Time frame: Up to 52 months
Part 2: Number of Participants with severity of ocular events by the Keratopathy Visual Acuity (KVA) scale
Time frame: Up to 52 months
Part 2: Overall Response Rate (ORR)
Time frame: Up to 52 months
Part 3: Very Good Partial Response and better rate (VGPR+)
Time frame: Up to 52 months
VGPR+ is defined as the percentage of participants with a confirmed VGPR or better (i.e., VGPR, complete response, stringent complete response).
26 secondary outcomes
Part 1: Overall Response Rate (ORR)
Time frame: Up to 52 months
Part 1: Observed Plasma Concentration of belantamab
Time frame: Up to 52 months
Part 1: Area Under the Curve (AUC) of belantamab
Time frame: Up to 52 months
Part 1: Maximum Concentration (Cmax) of belantamab
Time frame: Up to 52 months
Part 1: Number of Participants with Anti-Drug Antibodies (ADA) against belantamab
Time frame: Up to 52 months
Part 1: Titers of ADA against belantamab
Time frame: Up to 52 months
Part 2: Duration of Response (DoR)
Time frame: Up to 52 months
Part 2: Observed Plasma Concentration of Total belantamab
Time frame: Up to 52 months
Part 2: Area Under the Curve (AUC) of Total belantamab
Time frame: Up to 52 months
Part 2: Maximum Concentration (Cmax) of Total belantamab
Time frame: Up to 52 months
Part 2: Observed Plasma Concentration of belantamab mafodotin (ADC)
Time frame: Up to 52 months
Part 2: Area Under the Curve (AUC) of belantamab mafodotin (ADC)
Time frame: Up to 52 months
Part 2: Maximum Concentration (Cmax) of belantamab mafodotin (ADC)
Time frame: Up to 52 months
Part 2: Observed Plasma Concentration of Cys-Monomethyl Auristatin-F (Cys-mcMMAF)
Time frame: Up to 52 months
Part 2: Area Under the Curve (AUC) of Cys-mcMMAF
Time frame: Up to 52 months
Part 2: Maximum Concentration (Cmax) of Cys-mcMMAF
Time frame: Up to 52 months
Part 2: Number of Participants with ADAs against belantamab and belantamab mafodotin
Time frame: Up to 52 months
Part 2: Titers of ADAs against belantamab and belantamab mafodotin
Time frame: Up to 52 months
Part 3: Minimal residual disease (MRD) negativity rate in participants achieving at least VGPR
Time frame: Up to 52 months
Part 3: Overall Response Rate (ORR)
Time frame: Up to 52 months
Part 3: Duration Of Response (DoR)
Time frame: Up to 52 months
Part 3: Observed Plasma Concentration of Total belantamab
Time frame: Up to 52 months
Part 3: Area Under the Curve (AUC) of Total belantamab
Time frame: Up to 52 months
Part 3: Maximum Concentration (Cmax) of Total belantamab
Time frame: Up to 52 months
Part 3: Number of Participants with ADAs against belantamab
Time frame: Up to 52 months
Part 3: Titers of ADAs against belantamab
Time frame: Up to 52 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Individual participant dataSharing planned: No. Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk-studyregister.com/gsk-patient-level-data-sharing-july2025.pdf
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
GSK Clinical Trials study director
GlaxoSmithKline
44 sites in 13 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Belantamab, Belantamab mafodotin and Pomalidomide in people with Multiple Myeloma, run by GlaxoSmithKline at 44 sites in 13 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 28 inclusion and 34 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 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 44 sites in United States, Japan, Argentina, Brazil, Israel and 8 more countries. 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?
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 US GSK Clinical Trials Call Center (877-379-3718, GSKClinicalSupportHD@gsk.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parts 1, 2 and 3: Number of Participants with any Adverse Event (time frame: Up to 52 months). 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?
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 19 Aug 2026.