Multiple Myeloma Support + Trials

What's the purpose of this trial?

This is a Phase 1, open-label, multicenter study to evaluate the safety and to determine the optimal dose of bb2121 in patients with newly diagnosed multiple myeloma who are specifically considered ‘high risk’ (meaning that the disease stage and genetic testing are linked to a poor prognosis).

This trial is currently open and accepting patients.

What's being studied?

Cyclophosphamide is a chemotherapy agent used in the treatment of cancer.
Dexamethasone is a steroid given in conjunction with some cancer treatments.
Fludarabine is a chemotherapy agent used in the treatment of cancer.
Idecabtagene Vicleucel (ide-cel, bb2121) is a Chimeric Antigen Receptor (CAR) T cell therapy. Your own T cells are removed and altered in a lab to recognize BCMA, a protein carried by multiple myeloma cells.
Lenalidomide is an immunomodulatory drug that helps your body fight cancer by stimulating antibody formation and also by slowing tumor growth.

What will happen during the trial?

This trial is seeking approximately 30-60 people living with newly diagnosed multiple myeloma who are specifically considered ‘high risk’ (meaning that the disease stage and genetic testing are linked to a poor prognosis) to participate.

This trial is organized into a single arm, which means that all participants are planned to receive bb2121.

This trial is organized into four parts: Pre-Treatment, Treatment, Post-Treatment, and Survival Follow-up.

Pre-Treatment – During this part of the trial, you will receive four cycles of an anti-myeloma treatment regimen. A cycle is a period of treatment followed by a period of rest (no treatment) that is repeated on a regular schedule. Participants will undergo the collection of their T cells (leukapheresis) to make into bb2121 after the third cycle of anti-myeloma therapy. The study doctor will determine which of the anti-myeloma regimens you will receive before leukapheresis.

Treatment – During this part of the trial you will receive lymphodepleting chemotherapy (chemotherapy treatment that removes some of your own immune cells, making space for the bb2121 T cells to grow in your body, and to increase the chances of your body’s ability to accept the bb2121 T cells) and bb2121. Approximately 5 days before you receive bb2121, you will receive three consecutive days of lymphodepleting chemotherapy. This is necessary to remove some of your immune cells to make room for bb2121, and to help your body to accept the bb2121 cells. When you receive bb2121, you will be hospitalized for approximately 14 days so that your study doctor can monitor you closely for side effects.

Post-Treatment - Once you are discharged from the hospital, you will need to stay within a 30 minute drive from your treating hospital and have a dedicated caregiver staying with you for the remainder of the 30 days following your bb2121 treatment. You will need to visit your study site for follow-up monthly for the first 6 months, then every 3 months for the first two years. Your study doctor may prescribe a maintenance anti-myeloma therapy like Lenalidomide for you during this time.

Follow-up – Study staff will continue to contact you approximately every 3 months to obtain information on how you are doing up until 2 years after the last patient receives bb2121. They may ask you to undergo testing to see if bb2121 cells are still present in your body, and if they have changed in any way.

There is an optional longer term follow-up safety study that may last 15 years

See if you qualify

Additional Trial Information

Phase 1

Enrollment: 60 patients (estimated)

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I'm Interested

You may be able to join this trial if you:

The following criteria is a partial list of reasons why patients may be eligible to participate in this clinical trial. Further evaluation with a medical professional is required. Create your account or call us today for help (888) 828-2206.

Participants must be newly diagnosed with high risk multiple myeloma, and have received 3 or less cycles of certain types of induction (initial) treatment as defined by study requirements.
Patients must not have non-secretory myeloma, and must meet the measurable disease criteria for this study.
Participants must not have central nervous system involvement of their myeloma.
Participants must have adequate bone marrow, kidney, liver, lung and cardiac function to safely participate in this study.

View Additional Criteria

Inclusion Criteria:

Subjects must satisfy all of the following criteria to be enrolled in the study:

Subject is newly diagnosed and has symptomatic Multiple Myeloma (MM) prior to initiating induction anti-myeloma therapy
Subject is ≥ 18 years of age at the time of initial diagnosis of MM
Subject has measurable disease at initial diagnosis by
- M-protein and/or
- Light chain MM without measurable disease in the serum or urine
Subject has high-risk MM at the time of initial diagnosis of MM per R-ISS Stage III as defined by IMWG:
- ISS Stage III and cytogenetic abnormalities with t(4; 14) and/or del(17p); and/or t(14:16) by iFISH; or;
- ISS Stage III and serum LDH > ULN
Subject has Eastern Cooperative Oncology Group performance ≤ 1
Subjects has received ≤ to 3 cycles of the following induction anti-myeloma therapy prior to enrollment:
- Cycle 1: one of the following regimens (RVd, KRd, CyBorD, D-RVd and D-KRd)
- Cycle 2 to Cycle 3: either KRd or RVd (Cycle 3 must be without dexamethasone)

Exclusion Criteria:

The presence of any of the following will exclude a subject from enrollment: The presence of any of the following will exclude a subject from enrollment:

At initial diagnosis, screening and prior to initiation of induction therapy for MM:

Subject has non-secretory MM

During Screening:
Subject received any treatments for MM other than up to 3 cycles of induction therapy per protocol
Subject has any of the following laboratory abnormalities:
1. Absolute neutrophil count < 1,000/μL
2. Platelet count < 50,000 mm3
3. Hemoglobin < 8 g/dL (< 4.9 mmol/L)
4. Serum creatinine clearance < 45 mL/min
5. Corrected serum calcium > 13.5 mg/dL (> 3.4 mmol/L)
6. Serum aspartate aminotransferase or alanine aminotransferase > 2.5 × upper limit of normal
7. Serum total bilirubin > 1.5 × ULN or > 3.0 mg/dL for subjects with documented Gilbert's syndrome
8. INR or aPTT > 1.5 × ULN
Subject has history or presence of clinically significant CNS pathology
Subjects has high risk for developing deep vein thrombosis or pulmonary embolus and are unable or unwilling to undergo anti-thrombotic therapy
Subject has peripheral neuropathy of > Grade 2 severity according to the NCI CTCAE Version 4.03 with bortezomib based induction regimen
Subjects has moderate or severe pulmonary hypertension
Subject has intolerance to components of induction regimen (KRd or RVd) or has any contraindication to one or the other drug
Subject has not recovered from induction therapy-related toxicities (non-hematologic) to < grade 1 CTCAE at the time of screening
Subject has prior history of deep vein thrombosis or pulmonary embolus (PE) within 6 months of starting study treatment
Subject has cardiac conditions such as:
1. Echocardiogram or multi gated acquisition assessment of left ventricular ejection fraction < 45%
2. Subject has a history of clinically significant cardiovascular disease or clinically significant ECG abnormalities
Subject has Pulmonary conditions such as:
1. Subject has known chronic obstructive pulmonary with a forced expiratory vol in 1 sec 50% of predicted normal.
2. Inadequate pulmonary function defined as oxygen saturation < 92 % on room air
Subject needs ongoing treatment with chronic immunosuppressants
Subject has history of primary immunodeficiency
Subject is seropositive for human immunodeficiency virus, chronic or active hepatitis B or active hepatitis A or C

All Trial Locations

View all clinical trial locations sorted by state.

Colorado

Colorado Blood Cancer Institute Presbyterian/St. Luke's Medical Center (HealthONE)

Denver, CO

Open and Accepting

Florida

Mayo Clinic (Jacksonville)

Jacksonville, FL

Open and Accepting

Georgia

Winship Cancer Institute of Emory University

Atlanta, GA

Open and Accepting

New Jersey

John Theurer Cancer Center Hackensack Meridian Health

Hackensack, NJ

Open and Accepting

Tennessee

Sarah Cannon TriStar Centennial Medical Center

Nashville, TN

Open and Accepting

Trial Links

Read the latest news and updates on this trial.

Highly Refractory Myeloma Has Deep and Durable Responses With Ide-cel

December 05, 2020

Patients with heavily pretreated multiple myeloma maintained durable responses with the chimeric antigen receptor (CAR) T-cell therapy idecabtagene vicleucel (ide-cel; bb2121) in updated findings presented from the phase 1 CRB-401 trial (NCT02658929).

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