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Multiple MyelomaPhase 1NCT04036461

A Study of CC-99712, a BCMA Antibody-Drug Conjugate, in Participants With Relapsed and Refractory Multiple Myeloma

A Phase 1 study testing CC-99712 and BMS-986405 in people with Multiple Myeloma, run by Celgene at 20 sites in 5 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Study CC-99712-MM-001 is an open-label, Phase 1, dose escalation (Part A) and expansion (Part B), First-in-Human (FIH) clinical study of CC-99712 in monotherapy or combination with BMS-986405 in participants with relapsed and refractory multiple myeloma (MM). 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?
CC-99712 and BMS-986405
Could I receive a placebo?
No, everyone receives an active treatment
How many people
47 participants
Where
20 sitesin 5 countries
Study dates
26 Aug 2019to 19 Aug 2024
Phase
Phase 1
Are there results?
None posted in the registry

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

  • Participant is ≥ 18 years of age at the time of signing the ICF.
  • Participant has a history of multiple myeloma (MM) with relapsed and/or refractory disease
  • Participant must have measurable disease.
  • Participant has an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.

Who cannot join

  • Participant has symptomatic central nervous system involvement of MM.
  • Participant had a prior autologous stem cell transplant ≤ 3 months prior to starting CC-99712.
  • Participant had a prior allogeneic stem cell transplant with either standard or reduced intensity conditioning ≤ 6 months prior to starting CC-99712 or is on systemic immunosuppression for graft-versus host disease.
  • Subject is a pregnant or lactating female.
  • Subject has known human immunodeficiency virus (HIV) infection.
  • Subject has active hepatitis B or C (HBV/HCV) infection.
  • Other protocol-defined inclusion/exclusion criteria apply

Trial locations and contacts

20 sites in 5 countries.

20 sites in 5 countries

United States7 sites

  • Local Institution - 103

    Buffalo, New York, 14263

  • Local Institution - 104

    Dallas, Texas, 75390

  • Local Institution - 107

    La Jolla, California, 92093

  • Local Institution - 106

    New York, New York, 10029

  • Local Institution - 101

    Portland, Oregon, 97239

  • Local Institution - 105

    Sarasota, Florida, 34232

  • Local Institution - 102

    Seattle, Washington, 98104

Other trials in United States

Spain6 sites

  • Local Institution - 405

    Barcelona, 08036

  • Local Institution - 401

    Madrid, 28041

  • Local Institution - 0505

    Málaga, 29010

  • Local Institution - 402

    Salamanca, 37007

  • Local Institution - 404

    Sevillla, 41013

  • Local Institution - 403

    Valencia, 46026

Other trials in Spain

France4 sites

  • Institut Paoli Calmettes

    Marseille, 13273

  • CHU Montpellier - Hôpital Saint Eloi

    Montpellier, 34295

  • Hopital Saint Antoine

    Paris, 75571

  • Local Institution - 305

    Pierre-Bénite, 69495

Other trials in France

Canada2 sites

  • Local Institution - 201

    Montreal, Quebec, H1T 2M4

  • Local Institution - 202

    Toronto, Ontario, M5G 2M9

Other trials in Canada

Italy1 site

  • Local Institution - 501

    Bologna, 40138

Other trials in Italy

About this study

Official title: A Phase 1, Multicenter, Open-label, Dose Finding Study of CC-99712, a BCMA Antibody-Drug Conjugate, in Subjects With Relapsed and Refractory Multiple Myeloma

Study CC-99712-MM-001 is an open-label, Phase 1, dose escalation (Part A) and expansion (Part B), First-in-Human (FIH) clinical study of CC-99712 in monotherapy or combination with BMS-986405 in participants with relapsed and refractory multiple myeloma (MM). The dose escalation part (Part A) of the study will evaluate the safety and tolerability of escalating doses of CC-99712, administered intravenously (IV) in monotherapy (Arm 1) or combination with BMS-986405 (Arm 2), to determine the maximum tolerated dose (MTD) of CC-99712 guided by a Bayesian logistic regression model (BLRM). A modified accelerated titration design will also be used for Arm 1 and Arm 2. The MTD may be established separately for CC-99712 administered at Q3W and/ or Q4W schedules. The expansion part (Part B) will further evaluate the safety and efficacy of CC-99712 in monotherapy (Arm 1) or combination (Arm 2) administered at or below the MTD in selected expansion cohorts in order to determine the RP2D. One or more doses or dosing regimens may be selected for cohort expansion. All participants will be treated until confirmed disease progression per IMWG criteria, unacceptable toxicity, or participants//Investigator decision to withdraw.

Being tested
CC-99712, BMS-986405
Keywords
Multiple Myeloma, Relapsed and refractory, CC-99712, BCMA, Antibody drug conjugate, BMS-986405
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.

  • CC-99712Drug

    CC-99712

  • BMS-986405Drug

    Also called GSI (Gamma secretase inhibitor)

    BMS-986405

Study groups in NCT04036461
Study groupRoleWhat they receive
Arm 1 (CC-99712 monotherapy)ExperimentalCC-99712 will be administered via intravenous (IV) infusion.
Receives: Drug: CC-99712
Arm 2 (CC-99712 and BMS-986405 combination)ExperimentalCC-99712 will be administered via IV infusion. BMS-986405 will be administered orally.
Receives: Drug: CC-99712; Drug: BMS-986405

What is being measured

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

  1. Adverse Events (AEs)

    Number of participants with adverse event

    Measured: From enrollment until at least 42 days after completion of study treatment

  2. Maximum Tolerated Dose (MTD) in participants with relapsed and refractory MM

    Is defined as the highest dose that causes DLTs in no more than 33% of patient population during the first cycle of treatment.

    Measured: Up to 28 days

  3. Dose Limiting Toxicity (DLT) in participants with relapsed and refractory MM

    Is defined as any of the following toxicities occurring within the DLT assessment window

    Measured: Up to 28 days

Secondary outcomes (11)

  1. Overall Response Rate (ORR)

    Is defined as the proportion of participants who achieve a partial response or better (eg, Partial response (PR), Very good partial response (VGPR), Complete response (CR) or sCR), according to IMWG response criteria.

    Measured: Up to 3 years

  2. Time to Response

    Is defined as the time from the first CC-99712 dose date to the date of first documented response (PR or better).

    Measured: Up to 3 years

  3. 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.

    Measured: Up to 3 years

  4. Progression-free Survival (PFS)

    Is defined as the time from the first dose of CC-99712 to progressive disease (PD) or death from any cause, whichever occurs first.

    Measured: Up to 3 years

  5. Overall Survival (OS)

    Is defined as the time from the first dose of CC-99712 to death from any cause.

    Measured: Up to 3 years

  6. Pharmacokinetics- Cmax

    Maximum plasma concentration of drug

    Measured: Up to 3 years

  7. Pharmacokinetics- Tmax

    Time to peak (maximum) serum concentration

    Measured: Up to 3 years

  8. Pharmacokinetics- AUC(TAU)

    Area under the serum concentration time-curve

    Measured: Up to 3 years

  9. Pharmacokinetics- CLT

    Total body clearance of the drug from the serum

    Measured: Up to 3 years

  10. Pharmacokinetics- Ctrough

    Lowest concentration of drug immediately prior to administration of the next dose

    Measured: Up to 3 years

  11. Presence and frequency of ADA using a validated bridging immunoassay with electrochemiluminescence detection

    Anti-CC-99712 antibodies

    Measured: Up to 3 years

Timeline

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

  1. First posted29 Jul 2019
  2. Study start26 Aug 2019
  3. Primary completion8 Jul 2024
  4. Study completion19 Aug 2024

Why it stopped: Slow accrual

Resources

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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
47 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04036461
Sponsor's protocol ID
CC-99712-MM-001
Other IDs
U1111-1231-9404, 2020-004514-35
Status last verified
Aug 2024
First submitted
25 Jul 2019
Last updated
30 Aug 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Information relating to our policy on data sharing and the process for requesting data can be found at the following link: https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing CC-99712 and BMS-986405 in people with Multiple Myeloma, run by Celgene at 20 sites in 5 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 4 inclusion and 7 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: stopped early, as of the sponsor's last update on 30 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in United States, Spain, France, Canada, Italy. 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?

The study was stopped early (reason given: Slow accrual). Results are not available in the source record.

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?

Adverse Events (AEs) (time frame: From enrollment until at least 42 days after completion of study treatment). The study lists 3 primary outcomes in all. 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 NCT04036461.

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 30 Aug 2024.

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