A Phase 1 interventional study of CC-93269 in Multiple Myeloma, sponsored by Celgene. Terminated at 34 sites in 6 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-17.
Sponsored by Celgene (part of Bristol-Myers Squibb) · Phase 1, Interventional, and Treatment
Study CC-93269-MM-001 is an open-label, Phase 1, dose escalation (Part A and C) and expansion (Parts B and D), first-in-human clinical study of CC-93269 in subjects with relapsed and refractory multiple myeloma.
The dose escalation parts (Part A with CC-93269 administered intravenous (IV) and Part C subcutaneous (SC)) of the study will evaluate the safety and tolerability of escalating doses of CC-93269, administered IV or SC, to determine the maximum tolerated dose (MTD) and non-tolerated dose (NTD) of CC-93269. The expansion parts (Part B and D) will further evaluate the safety and efficacy of CC-93269 administered IV or SC at or below the MTD in selected expansion cohorts of up to approximately 20 evaluable subjects each in order to determine the Recommended Phase 2 dose (RP2D).One or more dosing regimens may be selected for cohort expansion. All treatments will be administered in 28-day cycles for up to 5 years for subjects maintaining clinical benefit, or until confirmed disease progression, unacceptable toxicity, or subject/investigator decision to withdraw.
3,760 studies on the registry are indexed under Multiple Myeloma; 769 are open to participants now.
This study's enrollment of 183 is above the median of 41 across 3,005 interventional studies indexed under Multiple Myeloma.
Browse Multiple Myeloma studies →Celgene is the lead sponsor of 428 studies on the registry; 12 are open to participants now.
Of its 104 completed or terminated interventional studies of FDA-regulated products, 30 (29%) have results posted.
First submitted before Celgene became part of Bristol-Myers Squibb.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria apply
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Allogeneic and autologous transplant
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: CC-93269
Specified dose on specified days
Also known as: Alnuctamab
Adverse Events (AEs)
Number of participants with Adverse Events
Time frame: Up to approximately 63 months
Dose Limiting Toxicity (DLT)
Is defined as any of the toxicities occurring within the DLT assessment window (Cycle 1, Days 1 to 28) except those that are clearly and incontrovertibly due to extraneous causes.
Time frame: Up to 60 months
Non-Tolerated Dose (NTD)
Is defined as a dose level at which 2 or more of up to 6 evaluable subjects in any dose cohort experience a DLT in the DLT window.
Time frame: Up to 60 months
Maximum Tolerated Dose (MTD)
Is defined as the last dose cohort below the NTD with 0 or 1 out of 6 evaluable subjects experiencing a DLT during the DLT window.
Time frame: Up to 60 months
Overall Response Rate (ORR)
Is defined as the proportion of subjects who achieve a partial response or better (eg, PR, VGPR, CR or sCR), according to International Myeloma Working Group (IMWG) response criteria.
Time frame: Up to 60 months
Time to Response
Is defined as the time from the first CC-93269 dose date to the date of first documented response (PR or better).
Time frame: Up to 60 months
Duration of Response
Is defined as the time from the earliest date of documented response (≥ PR) to the first documented disease progression or death, whichever occurs first.
Time frame: Up to 60 months
Progression Free Survival
Is defined as the time from the first dose of CC-93269 to progressive disease or death from any cause, whichever occurs first.
Time frame: Up to 60 months
Overall Survival
Is defined as the time from the first dose of CC-93269 to death from any cause.
Time frame: Up to 60 months
Pharmacokinetics - Cmax
Maximum serum concentration of drug
Time frame: Up to 60 months
Pharmacokinetics - Cmin
Minimum serum concentration of drug
Time frame: Up to 60 months
Pharmacokinetics - AUC
Area under the curve
Time frame: Up to 60 months
Pharmacokinetics - tmax
Time to peak (maximum) serum concentration
Time frame: Up to 60 months
Pharmacokinetics - t1/2
Terminal Half-life
Time frame: Up to 60 months
Pharmacokinetics - CL
Apparent total body clearance
Time frame: Up to 60 months
Pharmacokinetics - Vss
Volume of distribution at steady-state
Time frame: Up to 60 months
Pharmacokinetics - accumulation index of alnuctamab
Accumulation ratio of drug
Time frame: Up to 60 months
Presence and frequency of anti-drug antibodies (ADA)
Detection of anti-drug antibodies in participants and frequency of anti-drug antibodies
Time frame: Up to 60 months
Ran from Apr 2018 to primary completion in Mar 2025, 83 months.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Alnuctamab