All studies
Active not recruitingPHASE1, PHASE2INTERVENTIONAL

A Study to Determine Dose, Safety, Tolerability and Efficacy of CC-220 Monotherapy, and in Combination With Other Treatments in Subjects With Multiple Myeloma

This research is looking into a new treatment called CC-220 for a type of blood cancer called multiple myeloma. It's happening in different hospitals across various countries. The main goals are to figure out the best dose of CC-220, check if it's safe and doesn't cause too many problems, and see how well it works to treat the cancer. The study has two main parts. The first part tests CC-220 on its own or teamed up with other common medicines like dexamethasone, daratumumab, bortezomib, or carfilzomib. This helps researchers find the ideal dose. The second part then uses this chosen dose with other treatments for people whose multiple myeloma has come back or is newly diagnosed. Participants will be closely monitored to see how they respond to the treatment.

At a glance

Status
Active not recruiting
Phase
PHASE1, PHASE2
Sponsor
Celgene
Enrolment target
466
Start
14 Oct 2016
Estimated completion
28 Jul 2028

Results

Results from this study

Posted March 2026

Results have been published for this study.

Primary outcome
Number of Participants With Dose Limiting Toxicities in Part 1.
The dose-limiting toxicity (DLT) population includes subjects who missed no more than 4 doses of CC-220, 2 doses of DEX, 1 dose of IV DARA (Cohort E), 1 dose of BTZ (Cohort F), or 1 dose of CFZ (Cohort G1 or G2) during Cycle 1 for reasons other than DLT. This population will be used for analyzing the primary endpoint regarding the determination of the MTD. Hematologic DLTs: Grade 4 neutropenia (ANC \<500/μL for \>5 days) Grade 3 neutropenia (ANC \<1,000/μL) with fever ≥38.5°C Grade 4 thrombocytopenia (platelet count \<25,000/μL) or Grade 3 thrombocytopenia with bleeding or need for platelet transfusion Any other grade 4 hematologic toxicity, except anemia, not resolving to pretreatment baseline within 72 hours. Non-hematologic DLT: Any non-hematological toxicity ≥ Grade 3, except alopecia and nausea controlled by medical management.
Full results on the registry

What is this study about?

This study is investigating a new medication called CC-220 for patients who have multiple myeloma. Multiple myeloma is a type of cancer that affects plasma cells, a kind of white blood cell found in the bone marrow. The study is designed to understand how best to use CC-220, both by itself and when combined with other established treatments for multiple myeloma, such as dexamethasone, daratumumab, bortezomib, and carfilzomib.

The research has two main stages. In the first stage, different doses of CC-220 are tested to see which amounts are safe and manageable for patients. This involves giving CC-220 alone or with one or more of the other standard treatments. Once the research team finds the most suitable and safe dose, they move to the second stage. In this stage, the chosen dose of CC-220, combined with other medicines, will be given to a larger group of patients. This second stage focuses on patients whose multiple myeloma has either returned after previous treatment or those who have been newly diagnosed.

The overall aim is to gather important information about CC-220. Researchers want to know: What is the safest and most effective dose? What side effects might it cause? And how well does it help control or improve multiple myeloma? This type of study, called a clinical trial, is a crucial step in developing new medicines and improving care for conditions like multiple myeloma.

Key takeaways

  • This study is testing a new drug, CC-220, for people with multiple myeloma.
  • It aims to find the safest and most effective dose, and check for side effects.
  • CC-220 is tested alone or with other common myeloma treatments.
  • The study includes patients whose myeloma has returned or are newly diagnosed.
  • Close monitoring and regular check-ups are part of participating.

Who may be eligible?

To join this study, you generally need to be at least 18 years old. If you have multiple myeloma, your medical records must clearly show that you have the disease and that it can be measured, for example, by certain protein levels in your blood or urine. You also need to have experienced your multiple myeloma getting worse either during or within two months of your most recent treatment.

Your general health and how well you can perform daily activities will also be checked. This is measured using a system called ECOG, and you would typically need a score of 0, 1, or 2, which means you're fairly active and able to look after yourself. If you are newly diagnosed, your doctor will confirm your diagnosis based on specific criteria agreed upon by experts, which includes looking at the cancer cells in your bone marrow and checking for certain problems like high calcium, kidney issues, anaemia, or bone damage.

There are also specific checks related to the level of cancer cells in your bone marrow or certain markers in your blood. These help the doctors make sure the study includes people who are most likely to benefit from or help us understand this new treatment. The study team will review all your medical information carefully to see if you fit the criteria.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Are you at least 18 years old?
  2. Do you have a confirmed diagnosis of multiple myeloma that can be measured by tests?
  3. Has your multiple myeloma worsened recently (within 60 days of your last treatment)?
  4. Are you generally able to perform daily activities (ECOG score 0, 1, or 2)?
  5. If newly diagnosed, has your doctor confirmed your myeloma based on specific criteria involving bone marrow and organ damage?
Answer every question to see your result.

What does participation involve?

If you decide to join this study, you'll be part of a team effort to find new ways to treat multiple myeloma. Initially, you might receive CC-220 on its own or in combination with other existing treatments like dexamethasone, daratumumab, bortezomib, or carfilzomib. The doctors will start with a specific dose, and for some patients, this might be adjusted if it's not well-tolerated. For example, the starting dose of dexamethasone might depend on your age.

You will have regular appointments for check-ups and assessments. These visits will include tests to track your health and how the treatment is working. For some people, if their condition gets worse while on CC-220 alone, they might have the option to add dexamethasone to their treatment, after discussing it with the study doctor. Treatment will continue for as long as it's helping and you're not experiencing severe side effects, or until you decide you no longer wish to continue. If your condition improves or stabilises, but you stop the main study treatment for reasons other than the cancer progressing, you will still be followed up regularly to check on your condition, usually every 21 or 28 days.

Potential risks and benefits

Taking part in any medical study has potential benefits and potential risks. A possible benefit of joining this study is that you might have access to a new experimental drug, CC-220, which could potentially help treat your multiple myeloma. However, there's no guarantee it will work for everyone, and it might not be more effective than standard treatments. As with any medication, CC-220 or the combination treatments could cause side effects, which might be mild or more serious. The study team will closely monitor you for any side effects and manage them as best as possible. You are always free to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (162)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Local Institution - 102
    Verified postcode
    Scottsdale, United States
  • Mayo Clinic
    Verified postcode
    Scottsdale, United States
  • Local Institution - 107
    Verified postcode
    Little Rock, United States
  • University of Arkansas for Medical Sciences
    Verified postcode
    Little Rock, United States
  • Local Institution - 101
    Verified postcode
    Atlanta, United States
  • Winship Cancer Institute of Emory University
    Verified postcode
    Atlanta, United States
  • Local Institution - 120
    Verified postcode
    Chicago, United States
  • Robert H Lurie Comprehensive Cancer Center NW Univ
    Verified postcode
    Chicago, United States
  • Local Institution - 113
    Verified postcode
    Fairway, United States
  • University of Kansas Cancer Center
    Verified postcode
    Fairway, United States
  • Local Institution - 106
    Verified postcode
    Baltimore, United States
  • University of Maryland School of Med
    Verified postcode
    Baltimore, United States

Common questions

What is multiple myeloma?

Multiple myeloma is a type of cancer that begins in the plasma cells, a kind of white blood cell found in the bone marrow. These cells normally help fight infections. In multiple myeloma, they grow too much, overcrowding healthy cells.

What is CC-220?

CC-220 is a new drug being tested in this study. It's hoped to help treat multiple myeloma, either by itself or when given alongside other well-known cancer medications.

Are there other treatments besides CC-220 in this study?

Yes, some patients in the study will also receive other standard treatments for multiple myeloma, such as dexamethasone, daratumumab, bortezomib, or carfilzomib, combined with CC-220.

How long will I be in the study if I join?

The study treatment will continue as long as it's helping you and you're not experiencing too many side effects. If you stop the main treatment, you will still have regular follow-up checks for your condition.

Can I stop being part of the study at any time?

Yes, you have the right to withdraw from the study at any point, for any reason. Your decision will not affect your future medical care.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

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