What side effects are associated with this type of intervention?

Common treatments for Multiple Myeloma, such as bortezomib, lenalidomide, and carfilzomib, have a range of side effects. Bortezomib can cause fatigue, nausea, vomiting, peripheral sensory neuropathy, and hematological toxicities like neutropenia and thrombocytopenia. Lenalidomide is associated with neutropenia, thrombocytopenia, diarrhea, and fatigue. Carfilzomib, while having a lower incidence of neuropathy compared to bortezomib, can lead to cardiovascular issues and electrolyte disturbances. The BCMA antibody-drug conjugate CC-99712, currently under study, aims to determine its safety and tolerability, with potential side effects yet to be fully characterized.

What prior FDA approvals exist?

The FDA has approved several treatments for Multiple Myeloma that are similar to the ones being studied in the CC-99712 trial. Notably, bortezomib, a proteasome inhibitor, has been approved for use after one prior therapy. Additionally, lenalidomide, an immunomodulatory drug, is often used in combination with other agents like dexamethasone. Monoclonal antibodies such as daratumumab and elotuzumab have also been approved for relapsed or refractory Multiple Myeloma, often in combination with other drugs like lenalidomide and dexamethasone. These treatments focus on targeting specific proteins on myeloma cells, similar to the BCMA-targeting approach of CC-99712.

What other types of research exist?

Promising novel alternatives to CC-99712 for treating multiple myeloma include: <ol> <li>Milatuzumab: A humanized anti-CD74 monoclonal antibody, currently in clinical evaluation, showing potential when combined with bortezomib, doxorubicin, or dexamethasone.</li> <li></li> </ol> Lenalidomide and CC-4047: Second-generation immunomodulatory drugs (IMiDs) with enhanced anticancer properties and manageable toxicities. 3. Daratumumab: A monoclonal antibody used in combination with other agents like bortezomib and dexamethasone, showing efficacy in relapsed or refractory multiple myeloma. 4. Carfilzomib: A proteasome inhibitor that has demonstrated superior outcomes compared to bortezomib in certain patient populations. 5. Elotuzumab: When combined with lenalidomide and dexamethasone, it has shown extended progression-free survival in relapsed/refractory multiple myeloma.

← Back to Search

Monoclonal Antibodies

CC-99712 for Multiple Myeloma

Phase 1

Waitlist Available

Research Sponsored by Celgene

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Must not have

Subject has known human immunodeficiency virus (HIV) infection.

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.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug, CC-99712, alone or with another drug, BMS-986405, in patients with a type of blood cancer that has come back and doesn't respond to usual treatments. Researchers will gradually find the safest and most effective amount while checking for side effects and cancer treatment effectiveness.

Who is the study for?

This trial is for adults over 18 with multiple myeloma that has come back or hasn't responded to treatment. They must have measurable disease and be in good physical condition (ECOG PS of 0 or 1). It's not for pregnant women, those with HIV, brain involvement of MM, recent stem cell transplants, or active hepatitis B/C.

What is being tested?

The study tests CC-99712 alone or with BMS-986405 on participants with relapsed/refractory multiple myeloma. Part A finds the highest dose they can give without bad side effects (MTD) and Part B checks how well it works at this dose.

What are the potential side effects?

Possible side effects are not detailed here but typically include reactions related to the immune system's response to the drug, infusion-related reactions, fatigue, digestive issues and potential blood disorders.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

Select...

My multiple myeloma has come back or is not responding to treatment.

Select...

I am fully active or restricted in physically strenuous activity but can do light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am HIV positive.

Select...

I had a stem cell transplant less than 6 months ago or am on medication for graft-versus-host disease.

Select...

I have an active hepatitis B or C infection.

Select...

I had a stem cell transplant using my own cells less than 3 months ago.

Select...

My multiple myeloma has affected my brain or spinal cord.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Adverse Events (AEs)

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

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

Secondary study objectives

Duration of Response

Overall Response Rate (ORR)

Overall Survival (OS)

+8 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Arm 2 (CC-99712 and BMS-986405 combination)Experimental Treatment2 Interventions

CC-99712 will be administered via IV infusion. BMS-986405 will be administered orally.

Group II: Arm 1 (CC-99712 monotherapy)Experimental Treatment1 Intervention

CC-99712 will be administered via intravenous (IV) infusion.

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Multiple Myeloma include proteasome inhibitors (e.g., bortezomib), immunomodulatory drugs (e.g., lenalidomide), monoclonal antibodies (e.g., daratumumab), and antibody-drug conjugates targeting BCMA (e.g., belantamab mafodotin). Proteasome inhibitors disrupt protein degradation, leading to cancer cell death. Immunomodulatory drugs enhance the immune response against myeloma cells. Monoclonal antibodies target specific proteins on myeloma cells, marking them for destruction by the immune system. BCMA-targeted therapies, like the one in the CC-99712 trial, deliver cytotoxic agents directly to myeloma cells expressing BCMA, minimizing damage to healthy cells. These mechanisms are crucial as they offer targeted, effective treatment options, potentially improving outcomes and reducing side effects for Multiple Myeloma patients.

How I treat high-risk myeloma.