Extramedullary MyelomaPhase 1CARAMELNCT05666700

CAR-T Cell Therapy in RelApsed/Refractory Myeloma With ExtrameduLlary Disease - an in Vivo Imaging and Molecular Monitoring Study

A Phase 1 study testing Combination Product: JNJ-68284528 (Cilta-cel) & 64Cu SPION dual PET-MR imaging agent in people with Extramedullary Myeloma, run by Peter MacCallum Cancer Centre, Australia at 1 site in Australia.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

Search all trials

Trial summary

This clinical trial will investigate the in vivo trafficking of cilta-cel in extramedullary myeloma using 64Cu Super Paramagnetic Iron Oxide Nanoparticle (64Cu SPION) and Positron Emission Tomography-Magnetic Resonance Imaging (PET-MRI) Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Extramedullary Myeloma
What is being tested?: Combination Product: JNJ-68284528 (Cilta-cel) & 64Cu SPION dual PET-MR imaging agent
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 10 participants
Where: 1 siteAustralia
Study dates: 8 Dec 2023to Jan 2027
Phase: Phase 1
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

Patients must meet all the following criteria for study entry:
Patient has provided written informed consent
Patient is >18 years of age at the time of consent
Patient has a documented diagnosis of MM according to the IMWG diagnostic criteria (Appendix 1)
Measurable extramedullary disease by any imaging modality (at least one site of disease ≥1cm that has never received radiotherapy or has progressed following radiotherapy). Presence of biochemical measurable disease is not required
Have received at least 2 prior lines of therapy including a PTI and an IMiD. Patient must have undergone at least 1 complete cycle of treatment for each line of therapy, unless PD was the best response to the line of therapy (Appendix 2) Note: induction with or without haematopoietic stem cell transplant, consolidation and maintenance therapy is considered a single line of therapy.

Show all 26Show fewer

Have an ECOG Performance Status score of 0 or 1 (Appendix 3)
Have a life expectancy of ≥3 months, as judged by the Investigator
Able to undergo apheresis for mononuclear cell collection
Have clinical laboratory values meeting the following criteria within 7 days prior to registration (enrolment):
Haemoglobin ≥80g/L (recombinant human erythropoietin use is permitted)
ANC ≥1 × 109/L (prior growth factor support is permitted but must be without support in the 7 days prior to the laboratory test)
Platelet count ≥50 × 109/L
Absolute lymphocyte count ≥0.3 × 109/L
AST ≤3.0× ULN
ALT ≤3.0× ULN
Total bilirubin ≤2.0× ULN; except in patients with congenital bilirubinaemia, such as Gilbert's syndrome (in which case direct bilirubin ≤2.0× ULN is required)
Calculated CrCl ≥40mL/min calculated by the Cockcroft-Gault formula (Appendix 4), nuclear medicine assessment or a 24-hour urine collection
When a woman is of childbearing potential, the patient must commit either to abstaining continuously from heterosexual intercourse or agree to practice 2 methods of reliable birth control simultaneously. Where one of the methods is highly effective method of contraception (failure rate of <1% per year when used consistently and correctly; see examples below) and one other effective method (i.e., male latex or synthetic condom, diaphragm, or cervical cap) and patient must agree to remain on both methods from the time of signing the PICF until at least 1 year after receiving a cilta-cel infusion (Appendix 5). Reliable contraception is indicated even where there has been a history of infertility, unless it is due to hysterectomy. WOCBP should be referred to a qualified provider of contraceptive methods, if needed. Examples of highly effective contraceptives include:
User-independent methods: 1) implantable progestogen-only hormone contraception associated with inhibition of ovulation; 2) intrauterine device; intrauterine hormone-releasing system; 3) vasectomised partner
User-dependent method: progestogen-only hormone contraception associated with inhibition of ovulation (oral or injectable)
A man must commit either to abstaining continuously from heterosexual intercourse or a man who is sexually active with a WOCBP or a pregnant woman must agree to use a barrier method of contraception (e.g., latex or synthetic condom with spermicidal foam/gel/film/cream/suppository) from the time of signing the PICF until at least 1 year after receiving a cilta-cel, even if they have undergone a successful vasectomy
Women and men must agree not to donate eggs (ova, oocytes) or sperm, respectively, until at least 1 year after receiving a cilta-cel infusion
Patient must be willing and able to adhere to the following lifestyle restrictions during the study to be eligible for participation:
Refer to Section 8.6.3, Prohibited Therapies for details regarding prohibited and restricted therapy during the study
Agree to follow all requirements that must be met during the study as noted in the Inclusion and Exclusion Criteria (e.g., contraceptive requirements)

Who cannot join

Patients who meet any of the following criteria will be excluded from study entry:
Known nickel or Pd sensitivity
Weight >105 Kg and/or height >185 cm
Known claustrophobia
Prior treatment with CAR-T therapy directed at any target
Received a cumulative dose of corticosteroids equivalent to ≥70mg of prednisone within the 7 days prior to planned apheresis

Show all 52Show fewer

Any prior therapy that is targeted to BCMA
Vaccination with an investigational vaccine or live attenuated vaccine (except for COVID-19) within 4 weeks prior to planned conditioning
Patient received any anti-tumour therapy as follows, prior to planned apheresis:
Targeted therapy, epigenetic therapy, or treatment with an investigational drug or use of an invasive investigational medical device within 14 days or at least 5 half-lives, whichever is less
Investigational vaccine within 4 weeks
Monoclonal antibody treatment within 21 days
Cytotoxic therapy within 14 days
Radiotherapy within 14 days. However, if the radiation is given for palliative purposes and the radiation portal covered ≤5% of the bone marrow reserve, the patient is eligible irrespective of the end date of radiotherapy
Active malignancies (i.e., progressing or requiring treatment change in the last 24 months) other than the disease being treated under study. The only allowed exceptions are:
Non-muscle invasive bladder cancer treated within the last 24 months that is considered completely cured
Skin cancer (non-melanoma or melanoma) treated within the last 24 months that is considered completely cured
Non-invasive cervical cancer treated within the last 24 months that is considered completely cured
Localised prostate cancer (N0M0):
With a Gleason score of ≤6, treated within the last 24 months or untreated and under surveillance
With a Gleason score of 3+4 that has been treated more than 6 months prior to full study screening and considered to have a very low risk of recurrence, or
History of localised prostate cancer and receiving androgen deprivation therapy and considered to have a very low risk of recurrence
Breast cancer: adequately treated lobular carcinoma in situ or ductal carcinoma in situ, or history of localised breast cancer and receiving anti-hormonal agents and considered to have a very low risk of recurrence
Malignancy that is considered cured with minimal risk of recurrence
Plasma cell leukaemia at the time of screening (>2.0 x 109/L plasma cells by standard differential), Waldenström's macroglobulinaemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), or primary amyloid light-chain amyloidosis
Contraindications or known life-threatening allergies, hypersensitivity, or intolerance to any of the study treatments (if known) or any of their excipients, including boron, mannitol, and dimethyl sulfoxide (refer to IB), or local product prescribing information for complete lists of excipients
Pregnant or breast-feeding or planning to become pregnant while enrolled in this study or within 1 year after receiving cilta-cel infusion
Plans to father a child while enrolled in this study or within 1 year after receiving cilta-cel infusion
Stroke or seizure within 6 months prior to signing PICF
Received either of the following:
An allogenic stem cell transplant within 6 months before planned apheresis. Patients who received an allogeneic transplant must have stopped all immunosuppressive medications for 6 weeks without signs of graft-versus-host disease. Patients with active graft-versus-host disease are excluded
An ASCT ≤12 weeks before planned apheresis
Known active, or prior history of, CNS involvement or exhibits clinical signs of meningeal involvement of MM
Any of the following criterion related to infectious diseases:
Seropositive for HIV
Hepatitis B infection: In the event the infection status is unclear, quantitative viral levels are necessary to determine the infection status (Appendix 6)
Hepatitis C infection (defined as anti -HCV antibody positive or HCV-RNA positive) or known to have a history of hepatitis C NOTE: For patients with positive HCV antibody due to prior resolved disease can be enrolled, only if a confirmatory HCV RNA test is undetectable. For patients with known history of HCV infection, confirmation of sustained virologic response is required for study eligibility, defined as undetectable HCV RNA ≥24 weeks after completion of antiviral therapy.
Serious underlying medical or psychiatric condition or disease, that is likely to interfere with study procedures or results, or that in the opinion of the Investigator would constitute a hazard for participating in this study, such as:
Requirement of continuous supplemental oxygen
Evidence of active viral or bacterial infection, requiring systemic antimicrobial therapy, or uncontrolled systemic fungal infection
Active autoimmune disease
Overt clinical evidence of dementia or altered mental status
Any history of Parkinson's disease or other neurodegenerative disorder
Clinically significant cardiac conditions, such as:
NYHA Class III or IV congestive heart failure (Appendix 7) Short title: CARAMEL Page 60 of 128 Version: 1.0 Date: 17th November 2022
Myocardial infarction or coronary-artery-bypass graft ≤6 months prior to planned apheresis
History of clinically significant ventricular arrhythmia or unexplained syncope, not believed to be vasovagal in nature or due to dehydration
History of severe non-ischemic cardiomyopathy
Impaired cardiac function (LVEF <45%) as assessed by ECHO or MUGA scan performed ≤8 weeks before planned apheresis
Major operations or surgical procedures within 2 weeks prior to bridging therapy, or has surgery planned during the study or within 2 weeks after study treatment administration Note: patients with planned surgical procedures to be conducted under local anaesthesia may participate.
Frailty index of ≥ 2 according to Myeloma Geriatric Assessment score (Appendix 8)
Any issue that would impair the ability of the patient to receive or tolerate the planned treatment, to understand informed consent or any condition for which, in the opinion of the Investigator, participation would not be in the best interest of the patient (e.g., compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments

Trial locations and contacts

1 site in 1 country.

Australia1 site

Peter MacCallum Cancer Centre
Melbourne, Victoria, 3000

Other trials in Australia

About this study

Read the detailed description

This a Phase Ib exploratory study designed to investigate the in vivo trafficking of cilta-cel in extramedullary myeloma (EMM) using 64Cu SPION nanoparticles and PET-MRI imaging. It is planned that 10-30% of clinical dose of target number of cilta-cel will be labelled. The target number cilta-cel has been chosen based on the previous first in humans (FIH) study. The rationale to label of cilta-cel in the range of ≤30% is to ensure that reasonable positron emission tomography (PET) and magnetic resonance (MR) imaging quality by increasing the relative labelling dose, in the case low cell numbers are obtained. Additionally, the selected range is chosen to limit cellular toxicity and radiation exposure to the patient from the labelled cells. The unlabeled and labelled dose will be administered as scheduled by a two-part intravenous infusion in which the labelled cells are administered no later than 4hrs after the unlabeled infusion

Conditions: Extramedullary Myeloma
Being tested: Combination Product: JNJ-68284528 (Cilta-cel) & 64Cu SPION dual PET-MR imaging agent

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Combination Product: JNJ-68284528 (Cilta-cel) & 64Cu SPION dual PET-MR imaging agentBiological
Cilta-cel is a cellular immunotherapy derived from autologous CD3+ T-cells that have undergone ex vivo modification to target B-Cell Maturation Antigen (BCMA) on the surface of plasma cells. Cilta-cel will be administered as two IV infusions, ≥70% unlabeled and ≤30% labelled. The dose will be based on the patient's weight (kg) at apheresis

Study groups in NCT05666700
Study group	Role	What they receive
Cilta-cel	Experimental	Not described Receives: Biological: Combination Product: JNJ-68284528 (Cilta-cel) & 64Cu SPION dual PET-MR imaging agent

What is being measured

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

To determine the utility of 64Cu SPION labelling for in vivo real time monitoring of trafficking of anti-BCMA Chimeric Antigen Receptor T-Cell (CAR-T) cells in Relapsed/ Refractory (RR) EMM.
Detectable cells by PET assessed by the Deauville score >3
Measured: assessed up to one month (first month after infusion)

Secondary outcomes (7)

Safety of 64Cu SPION labelled cilta-cel for EMM
Incidence, nature and severity of adverse events (AEs) according to Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE v5.0) and 2019 American Society for Transplantation and Cellular Therapy (ASTCT) consensus criteria for cytokine release syndrome (CRS) and neurotoxicity, Serious Adverse Events (SAE), and Adverse Events of special interest (AESI)
Measured: From date of signing consent until study completion, assessed up to approximately 31 months
Complete response rate (CRR) by International Myeloma Working Group (IMWG) criteria
Using IMWG criteria
Measured: assessed up to approximately 13 months
Overall response rate (ORR) by IMWG criteria
Using IMWG criteria
Measured: assessed up to approximately 13 months
Minimal residual disease response by Adaptive ClonoSeq assay
on ctDNA at Day +1, Day +28, 12 weeks, 24 weeks, and 52 weeks post Day +28 and on Bone Marrow Aspirate (BMA) at Day +28 and at suspected CR
Measured: assessed up to approximately 13 months
Duration of Response by IMWG criteria
Defined as time from first response of stringent complete response (sCR), complete response (CR), very good partial response (VGPR) and partial response (PR) to time to progressive disease (PD)
Measured: assessed up to approximately 13 months
Progression free survival, defined as time from study enrolment until biochemical, radiological and/or clinical PD or death, according to IMWG criteria
by IMWG criteria
Measured: assessed up to approximately 13 months
Overall survival (OR)
defined as time from study enrolment to death
Measured: assessed up to approximately 31 months

Timeline

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

8 Dec 2023Jan 2027

First posted28 Dec 2022
Study start8 Dec 2023
Primary completionJan 2027 (estimated)
Study completionJan 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Extramedullary MyelomaStudies of the same condition, open and under way.
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
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 10 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05666700
Sponsor's protocol ID: 21/015
Acronym: CARAMEL
Status last verified: Jul 2026
First submitted: 4 Dec 2022
Last updated: 28 Jul 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 2
QLS4131 for Relapsed/Refractory Multiple Myeloma With Extramedullary Disease
Multiple Myeloma (MM)
RecruitingObservational study
Tissue, Blood, and Body Fluid Sample Collection From Patients With Hematologic Cancer
Chronic Myeloproliferative Disorders, Leukemia
Active, not recruitingObservational study
Infection Prophylaxis and Management in Treating Cytomegalovirus (CMV) Infection in Patients With Hematologic Malignancies Previously Treated With Donor Stem Cell Transplant
Hematopoietic/Lymphoid Cancer, Accelerated Phase Chronic Myelogenous Leukemia
RecruitingPhase 2
A Phase 2 Study of Radiotherapy-induced Immune Priming to Enhance Elranatamab (Elra) in Relapsed Refractory Multiple Myeloma (RRMM) With Extramedullary Disease (EMD) and Paramedullary Disease (PMD) "PRIME-EMD-PMD"
Phase 2, Radiotherapy-Induced Immune Priming
Not yet recruitingPhase 2
HP-001 Plus Dexamethasone for Relapsed/Refractory Multiple Myeloma With Extramedullary Disease
Multiple Myeloma (MM)

All Extramedullary Myeloma trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: CAR-T Cell Therapy in RelApsed/Refractory Myeloma With ExtrameduLlary Disease - an in Vivo Imaging and Molecular Monitoring Study
ClinicalTrials.gov ID: NCT05666700
Acronym / sponsor ID: CARAMEL / 21/015
Conditions: Extramedullary Myeloma
Phase: Phase 1
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 10 participants (estimated)
Lead sponsor: Peter MacCallum Cancer Centre, AustraliaUniversity, hospital or other
Collaborators: Janssen, LP
Study start: 8 Dec 2023 (actual)
Primary completion: Jan 2027 (estimated)
Study completion: Jan 2027 (estimated)
First posted: 28 Dec 2022 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Cilta-cel	Experimental	Biological: Combination Product: JNJ-68284528 (Cilta-cel) & 64Cu SPION dual PET-MR imaging agent

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (26 listed)

Patient has provided written informed consent
Patient is >18 years of age at the time of consent
Patient has a documented diagnosis of MM according to the IMWG diagnostic criteria (Appendix 1)
Measurable extramedullary disease by any imaging modality (at least one site of disease ≥1cm that has never received radiotherapy or has progressed following radiotherapy). Presence of biochemical measurable disease is not required
Have received at least 2 prior lines of therapy including a PTI and an IMiD. Patient must have undergone at least 1 complete cycle of treatment for each line of therapy, unless PD was the best response to the line of therapy (Appendix 2) Note: induction with or without haematopoietic stem cell transplant, consolidation and maintenance therapy is considered a single line of therapy.

Key exclusion criteria (52 listed)

Known nickel or Pd sensitivity
Weight >105 Kg and/or height >185 cm
Known claustrophobia
Prior treatment with CAR-T therapy directed at any target
Received a cumulative dose of corticosteroids equivalent to ≥70mg of prednisone within the 7 days prior to planned apheresis

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
Combination Product: JNJ-68284528 (Cilta-cel) & 64Cu SPION dual PET-MR imaging agentCilta-cel is a cellular immunotherapy derived from autologous CD3+ T-cells that have undergone ex vivo modification to target B-Cell Maturation Antigen (BCMA) on the surface of plasma cells. Cilta-cel will be administered as two IV infusions, ≥70% unlabeled and ≤30% labelled. The dose will be based on the patient's weight (kg) at apheresis	Biological	Cilta-cel

Primary outcome

To determine the utility of 64Cu SPION labelling for in vivo real time monitoring of trafficking of anti-BCMA Chimeric Antigen Receptor T-Cell (CAR-T) cells in Relapsed/ Refractory (RR) EMM.
Time frame: assessed up to one month (first month after infusion)
Detectable cells by PET assessed by the Deauville score >3

7 secondary outcomes

Safety of 64Cu SPION labelled cilta-cel for EMM
Time frame: From date of signing consent until study completion, assessed up to approximately 31 months
Complete response rate (CRR) by International Myeloma Working Group (IMWG) criteria
Time frame: assessed up to approximately 13 months
Overall response rate (ORR) by IMWG criteria
Time frame: assessed up to approximately 13 months
Minimal residual disease response by Adaptive ClonoSeq assay
Time frame: assessed up to approximately 13 months
Duration of Response by IMWG criteria
Time frame: assessed up to approximately 13 months
Progression free survival, defined as time from study enrolment until biochemical, radiological and/or clinical PD or death, according to IMWG criteria
Time frame: assessed up to approximately 13 months
Overall survival (OR)
Time frame: assessed up to approximately 31 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 28 Jul 2026.
Individual participant dataSharing planned: No

Related trials for Extramedullary Myeloma

Not yet recruitingPhase 2
QLS4131 for Relapsed/Refractory Multiple Myeloma With Extramedullary Disease
Multiple Myeloma (MM)
RecruitingObservational study
Tissue, Blood, and Body Fluid Sample Collection From Patients With Hematologic Cancer
Chronic Myeloproliferative Disorders, Leukemia
Active, not recruitingObservational study
Infection Prophylaxis and Management in Treating Cytomegalovirus (CMV) Infection in Patients With Hematologic Malignancies Previously Treated With Donor Stem Cell Transplant
Hematopoietic/Lymphoid Cancer, Accelerated Phase Chronic Myelogenous Leukemia
RecruitingPhase 2
A Phase 2 Study of Radiotherapy-induced Immune Priming to Enhance Elranatamab (Elra) in Relapsed Refractory Multiple Myeloma (RRMM) With Extramedullary Disease (EMD) and Paramedullary Disease (PMD) "PRIME-EMD-PMD"
Phase 2, Radiotherapy-Induced Immune Priming
Not yet recruitingPhase 2
HP-001 Plus Dexamethasone for Relapsed/Refractory Multiple Myeloma With Extramedullary Disease
Multiple Myeloma (MM)

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. This study is not recruiting at the moment.

Simon Harrison principal investigator

Peter MacCallum Cancer Centre, Australia

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 26 inclusion and 52 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: under way, not looking for participants, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Australia. 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 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.

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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To determine the utility of 64Cu SPION labelling for in vivo real time monitoring of trafficking of anti-BCMA Chimeric Antigen Receptor T-Cell (CAR-T) cells in Relapsed/ Refractory (RR) EMM. (time frame: assessed up to one month (first month after infusion)). 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 NCT05666700.

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 28 Jul 2026.