CAR T-cell Therapy

Lenalidomide and bb2121 for Multiple Myeloma

University of Pennsylvania Hospital Center, Philadelphia, PA
Lenalidomide and bb2121Phase 2RecruitingLed by Alfred Garfall, MDResearch Sponsored by Marcelo Pasquini, MD

Study Summary

This trial will test a new treatment for multiple myeloma that uses the patient's own cells.


Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Efficacy of BCMA CAR-T cell therapy
Secondary outcome measures
Assessment of Disease progression
Best Disease Response
Incidence of Cytokine Release Syndrome
+4 more
Other outcome measures
Exploratory Objective 1: Incidence of toxicities greater than or equal to grade 3 per the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Exploratory Objective 2: BCMA expression
Exploratory Objective 2: CAR T-cell persistence
+5 more

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Lenalidomide and bb2121Experimental Treatment1 Intervention
Patients complete apheresis and proceed to lymphodepleting chemotherapy with cyclophosphamide 300mg/m2 and fludarabine 30mg/m2 for 3 consecutive days followed by the infusion of BCMA CAR T-cells at a target dose of 450 x106 cells. Maintenance lenalidomide, starting at 10mg a day for 21 days of a 28-day cycle will be initiated at a minimum of at least 30 days, but no later than 180 days after the CAR T-cell infusion and will continue until the patient reaches 12 months post CAR T-cell infusion and continue free of progression.

Find a site

Who is running the clinical trial?

National Marrow Donor ProgramOTHER
59 Previous Clinical Trials
202,374 Total Patients Enrolled
7 Trials studying Multiple Myeloma
101,816 Patients Enrolled for Multiple Myeloma
National Cancer Institute (NCI)NIH
13,369 Previous Clinical Trials
41,215,225 Total Patients Enrolled
564 Trials studying Multiple Myeloma
192,692 Patients Enrolled for Multiple Myeloma
Blood and Marrow Transplant Clinical Trials NetworkNETWORK
49 Previous Clinical Trials
14,001 Total Patients Enrolled
6 Trials studying Multiple Myeloma
2,001 Patients Enrolled for Multiple Myeloma
Celgene a wholly owned subsidiary of BMSUNKNOWN
Marcelo Pasquini, MDLead Sponsor
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,713 Previous Clinical Trials
47,168,909 Total Patients Enrolled
26 Trials studying Multiple Myeloma
3,532 Patients Enrolled for Multiple Myeloma
Mary Horowitz, MD, MSStudy Director
Center for International Blood and Marrow Transplant Research
12 Previous Clinical Trials
3,656 Total Patients Enrolled
Marcelo C Pasquini, MD, MSStudy Director
Medical College of Wisconsin
Alfred Garfall, MDPrincipal Investigator
University of Pennsylvannia
6 Previous Clinical Trials
184 Total Patients Enrolled
6 Trials studying Multiple Myeloma
184 Patients Enrolled for Multiple Myeloma
Sergio Giralt, MDPrincipal Investigator
Memorial Sloan Kettering Cancer Center
12 Previous Clinical Trials
485 Total Patients Enrolled
6 Trials studying Multiple Myeloma
176 Patients Enrolled for Multiple Myeloma

Media Library

bb2121 (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05032820 — Phase 2
Multiple Myeloma Research Study Groups: Lenalidomide and bb2121
Multiple Myeloma Clinical Trial 2023: bb2121 Highlights & Side Effects. Trial Name: NCT05032820 — Phase 2
bb2121 (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05032820 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does age limit a person's ability to participate in this research?

"The age requirements for potential participants in this study are between 18-71 years old."

Answered by AI

What is the current status of lenalidomide and bb2121 in terms of FDA approval?

"Lenalidomide and bb2121 have some data backing its safety, but there is not yet any evidence that it is an effective medication. This gives it a Power team safety score of 2."

Answered by AI

Can patients sign up for this clinical trial right now?

"This clinical trial, as reported on, is actively recruiting participants. The original posting was on 1/5/2022, and the most recent update was on 9/22/2022."

Answered by AI

How many different hospitals are conducting this trial?

"At the moment, this research is being conducted out of 16 different sites. They are situated in New York, Madison, Milwaukee and a selection of other cities. If you're interested in participating it would be ideal to choose a location near to you in order to limit travel."

Answered by AI

What are lenalidomide and bb2121 used to treat?

"Lenalidomide and bb2121 is a immunomodulatory treatment that has shown efficacy in patients with at least two prior systemic chemotherapy regimens, ≥4 prior lines of therapy, amyloidosis."

Answered by AI

Are there other research projects that have looked at Lenalidomide and bb2121?

"The first clinical trial evaluating the lenalidomide and bb2121 combination was conducted in 2004 at Saint Joseph Regional Medical Center-Mishawaka. In total, there have been 346 completed studies investigating this treatment option. As of now, 278 trials are still ongoing with a large number of these based out of New York City."

Answered by AI

Why did researchers design this trial in this way?

"The primary objective of this trial is to assess the efficacy of BCMA CAR-T cell therapy over the course of one year. Secondary objectives include measuring disease progression (using the International Myeloma Working Group response categories) and non-relapse mortality rates."

Answered by AI

Might I be able to join this research project?

"This study is investigating whether lenalidomide can be an effective treatment for multiple myeloma in patients who have already undergone stem cell transplantation. The trial is looking for 40 participants between the ages of 18 and 71 who meet the following criteria: -Patients must have initiated maintenance therapy with lenalidomide-based regimen within 6 months after the auto HCT and have received at least 3 months of maintenance prior to enrollment.-Patients must have tolerated a minimum dose of lenalidomide 5 mg/day for 21 days of a 28-day cycle for greater than 2 cycles without having to stop due to"

Answered by AI

How many people are allowed to join this trial?

"In order to accurately test the efficacy of the proposed intervention, 40 individuals that meet specific prerequisites are required. These potential participants can be located at different sites, such as Memorial Sloan Kettering Cancer Center in New York or University of Wisconsin Hospitals and Clinics in Madison."

Answered by AI
~9 spots leftby Apr 2024