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Multiple MyelomaPhase 2NCT05032820

Upfront Chimeric Antigen Receptor T-Cell to Upgrade Response in Multiple Myeloma

A Phase 2 study testing Lenalidomide, bb2121 and Cyclophosphamide in people with Multiple Myeloma, run by Medical College of Wisconsin at 15 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This study is designed as a Phase II, multicenter, single arm trial to assess anti-B Cell Maturation Antigen (BCMA) chimeric antigen receptor (CAR) T-cells (bb2121) to improve post autologous hematopoietic cell transplant (HCT) responses among patients with 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?
Lenalidomide, bb2121 and Cyclophosphamide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
15 sitesUnited States
Study dates
5 Jan 2022to 20 Feb 2025
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Age greater than or equal to 18.00 years
  • Patients must meet the criteria for symptomatic MM requiring therapy (Appendix A) prior to initiating initial systemic anti-myeloma treatment.
  • Patients must have received initial systemic anti- myeloma therapy consisting of induction therapy and consolidation with high-dose melphalan (>140 mg/m^2 ) followed by an auto HCT (minimum cell dose of 2x10^6 CD34+ cells/kg (actual body weight) within 12 months from initiation of systemic anti-myeloma therapy.
  • Patient must have additional stored stem cells greater than or equal to 2x10^6 CD34+ cells per kg actual body weight.
  • Patients must be less than or equal to 12 months after autologous HCT at the time of enrollment.
  • 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.
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  • 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 toxicities.
  • Patients must have a VGPR or less (Section 3.1) in reference to time time of initiation of initial systemic anti-myeloma therapy at study enrollment.
  • Patients must have Karnofsky performance greater than or equal to 70.
  • Patients must have recovered to Grade 1 or baseline of any non-hematologic toxicities due to prior treatments, excluding Grade 2 neuropathy.
  • Absolute neutrophil count (ANC) greater than or equal to 1,500/mm3 without filgrastim use in the prior 14 days.
  • Platelet count greater than 100,000/mm^3 (without platelet transfusion in the previous 7 days or thrombopoietin mimetics in the previous 28 days).
  • Hemoglobin greater than 9 g/dL (without red blood cell transfusion in the previous 7 days).
  • Creatinine Clearance (CrCl) greater than or equal to 60 mL/min, measured or estimated by Cockcroft-Gault equation.
  • Corrected serum calcium less than or equal to 13.5 mg/dL.
  • Oxygen saturation greater than 92% on room air.
  • Hepatic Function: a. Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than or equal to 2.5 x upper limit of normal (ULN) b. Serum total bilirubin less than or equal to 2 x ULN. Patients who have been diagnosed with Gilbert's disease are permitted to exceed the defined bilirubin value of 2 x ULN
  • International ratio (INR) or partial thromboplastin time (PTT) less than 1.5 x ULN
  • Cardiac Function: left ventricular ejection fraction greater than 45% by echocardiogram or MUGA.
  • Patients must be willing and able to adhere to the study visit schedule and other protocol requirements including regulatory requirement of a 15 year follow up using the CIBMTR long term follow up mechanism.
  • Female patients of childbearing potential (FCBP1 ) must: a. Have a negative serum pregnancy test with a sensitivity of at least 50 mIU/mL prior to enrollment b. Agree to use, and be able to comply with, TWO acceptable methods of birth control (Appendix C), one highly effective method and one additional effective (barrier) method AT THE SAME TIME, from screening through at least 1 year following bb2121 infusion or 4 weeks following discontinuation of lenalidomide, whichever is later. c. Agree to abstain from breastfeeding from screening through at least 1 year following bb2121 infusion or 4 weeks following discontinuation of lenalidomide, whichever is later.
  • Male patients must: a. Agree to use a condom during sexual contact with a pregnant female or a FCBP, even if he has undergone a successful vasectomy, from screening through at least 1 year following bb2121 infusion or 4 weeks following discontinuation of lenalidomide whichever is later b. Must not donate sperm from screening through at least 1 year following bb2121 infusion or 4 weeks following discontinuation of lenalidomide whichever is later.

Who cannot join

  • Patients with a prior allogeneic hematopoietic cell.
  • Female of childbearing potential (FCBP) is a female who:
  • has achieved menarche at some point,
  • has not undergone a hysterectomy or bilateral oophorectomy or
  • has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).
  • Patients with disease progression (see Section 3.1.2 for disease progression definition) at any time prior to enrollment.
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  • Patients receiving any of the following less than 14 days prior to enrollment:
  • Plasmapheresis
  • Major surgery (as defined by the investigator)
  • Radiation therapy other than local therapy for MM-associated bone lesions
  • Use of any systemic anti-myeloma drug therapy (with the exception of lenalidomide maintenance)
  • Any investigational agents
  • Corticosteroids (Physiologic replacement, topical, intranasal and inhaled steroids are permitted)
  • Patients with known Central Nervous System (CNS) involvement with MM.
  • Patients with a prior organ transplant requiring systemic immunosuppressive therapy.
  • Patients who previously experienced toxicities related to lenalidomide resulting in permanent treatment discontinuation.
  • Patients who experienced thromboembolic events while on full anticoagulation during prior therapy with an immunomodulatory agent (IMiD).
  • Patients unwilling to take DVT prophylaxis while on lenalidomide maintenance.
  • Patients with history of greater than or equal to Grade 2 hemorrhage within 30 days of enrollment.
  • Patient requiring ongoing treatment with chronic, therapeutic dosing of anticoagulants (e.g. Warfarin, low molecular weight heparin, Factor Xa inhibitors).
  • Patients with history or presence of clinically relevant CNS pathology such as epilepsy, seizure, paresis, aphasia, stroke, subarachnoid hemorrhage or other CNS bleed, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis.
  • Patients with active or history of plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), or clinically significant amyloidosis.
  • Patients with purely non-secretory MM [prior to starting systemic therapy, absence of a monoclonal protein (M protein) in serum as measured by electrophoresis and immunofixation and the absence of Bence Jones protein in the urine defined by use of conventional electrophoresis and immunofixation techniques and the absence of involved serum free light chain greater than 100mg/L]. Patients with light chain MM detected in the serum by free light chain assay are eligible.
  • Patients with a history of Class III or IV congestive heart failure (CHF) or severe nonischemic cardiomyopathy, unstable or poorly controlled angina, myocardial infarction, or hemodynamically significant ventricular arrhythmia within the previous 6 months prior to starting study treatment.
  • Patients with ongoing treatment with chronic immunosuppressants (e.g. cyclosporine or systemic steroids at any dose). Physiologic replacement, intermittent topical, inhaled or intranasal corticosteroids are allowed.
  • Patients with active clinically significant autoimmune disease, defined as a history of requiring systemic immunosuppressive therapy and at ongoing risk for potential disease exacerbation. Patients with a history of autoimmune thyroid disease, asthma, or limited skin manifestations are potentially eligible.
  • Patients seropositive for human immunodeficiency virus (HIV-1), chronic or active hepatitis B or C, or acute hepatitis A. If any history of exposure to hepatitis B or C then DNA PCR should be negative.
  • Patients with previous history of treatment with any gene therapy-based therapeutic for cancer or investigational cellular therapy for cancer or BCMA targeted therapy.
  • Patients with prior malignancies except resected basal cell carcinoma or treated carcinoma in situ. Cancer treated with curative intent less than 5 years prior to enrollment will not be allowed unless approved by the Protocol Officer or one of the Protocol Chairs. Cancer treated with curative intent greater than 5 years prior to enrollment is allowed.
  • Female patients who are pregnant (positive beta-HCG), or breastfeeding, or who intend to become pregnant during participation in the study.
  • Patient with known allergy or hypersensitivity to any of the study medications, their analogues, or excipients in the various formulations of any agent.
  • Patient with serious medical of psychiatric illness likely to interfere with participation on this clinical study.
  • Patients with uncontrolled bacterial, viral or fungal infections (currently taking medication and with progression or no clinical improvement) at time of enrollment.
  • Patients unwilling or unable to provide informed consent 25. Patients unable or unwilling to return to the transplant center for treatment and follow up.

Trial locations and contacts

15 sites in 1 country.

15 sites in 1 country

United States15 sites

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Roswell Park Cancer Center

    Buffalo, New York, 14203

  • University of Virginia

    Charlottesville, Virginia, 22908

  • City of Hope National Medical Center

    Duarte, California, 91010

  • Duke University Medical Center

    Durham, North Carolina, 27705

  • Baylor College and Medicine

    Houston, Texas, 77030

  • University of Wisconsin Hospitals and Clinics

    Madison, Wisconsin, 53792

  • Loyola University Medical Center

    Maywood, Illinois, 60153

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Mount Sinai Medical Center

    New York, New York, 10029

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • Stanford Hospital and Clinics

    Palo Alto, California, 94305

  • University of Pennsylvania Hospital Center

    Philadelphia, Pennsylvania, 19104

  • University of California, San Francisco

    San Francisco, California, 94143

  • H. Lee Moffitt Cancer Center

    Tampa, Florida, 33612

Other trials in United States

About this study

Official title: Phase II Multicenter Trial of Anti-BCMA CAR T-Cell Therapy for MM Patients With Sub-Optimal Response After Auto HCT and Maintenance Len. BMTCTN1902

This study is designed as a Phase II, multicenter, single arm trial to assess anti-B Cell Maturation Antigen (BCMA) chimeric antigen receptor (CAR) T-cells (bb2121) to improve post autologous hematopoietic cell transplant (HCT) responses among patients with multiple myeloma (MM).

Read the detailed description

After meeting the eligibility criteria and enrolling on the trial, patients will undergo leukapheresis for collection of autologous lymphocytes, which will be sent to BMS/Celgene manufacturing facilities. Once cells have been manufactured, patients will then proceed to lymphodepleting chemotherapy with cyclophosphamide 300mg/m^2 and fludarabine 30mg/m^2 for 3 consecutive days followed by the infusion of BCMA CAR T-cells at a target dose of 450 x10^6 cells. Maintenance lenalidomide, starting at 5mg 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

Being tested
Lenalidomide, bb2121, Cyclophosphamide, Fludarabine, leukapheresis
Keywords
Multiple Myeloma, CAR T-cells, Anti-Myeloma Agents, lenalidomide, Maintenance Therapy, Hematologic Disorders, Infusion
Medical subject headings
Multiple Myeloma, Hematologic Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LenalidomideDrug

    Also called Revlimid

    Maintenance lenalidomide, starting at 5 mg 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 participant reaches 12 months post CAR T-cell infusion and continues free of progression

  • bb2121Biological

    Also called ide-cel

    Participants receive infusion of BCMA CAR T-cells at a target dose of 450 x 10^6 cells.

  • CyclophosphamideDrug

    300 mg/m^2/day for 3 consecutive days prior to the CAR T infusion

  • FludarabineDrug

    30 mg/m^2/day or 3 consecutive days prior to the CAR T infusion

  • leukapheresisProcedure or surgery

    Placement of central line catheter and leukapheresis

Study groups in NCT05032820
Study groupRoleWhat they receive
Lenalidomide and bb2121ExperimentalPatients complete apheresis and proceed to lymphodepleting chemotherapy with cyclophosphamide 300mg/m^2 and fludarabine 30mg/m^2 for 3 consecutive days followed by the infusion of BCMA CAR T-cells at a target dose of 450 x10^6 cells. Maintenance lenalidomide, starting at 5mg 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.
Receives: Drug: Lenalidomide; Biological: bb2121; Drug: Cyclophosphamide; Drug: Fludarabine; Procedure: leukapheresis

What is being measured

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

  1. Efficacy of BCMA CAR-T Cell Therapy

    Achieving a complete response or better (CR or sCR) as assessed by the 6-month time point after BCMA CAR T-cell therapy in MM patients with suboptimal disease responses after an autologous HCT and lenalidomide maintenance.

    Measured: 6 months

Secondary outcomes (7)

  1. Cumulative Incidence of Disease Progression

    Diseases will be assessed by response categories based on the International Myeloma Working Group: Stringent Complete Response (sCR), Complete Remission (CR), Very Good Partial Remission (VGPR), Partial Remission (PR), Minimal Response (MR), Stable Disease (SD).

    Measured: 1 Year

  2. Proportion of Patients Achieving an Upgrade in Response Based on Their Best Disease Response

    Proportion of patients achieving upgrade in response following enrollment (SD to MR or greater, MR to PR or greater, or PR to VGPR or greater) and Conversion to MRD negativity. MRD will be assessed by multi-color flow at 10-5 level

    Measured: 1 Year

  3. Number of Participants With Non Relapse Mortality

    Non-Relapse Mortality (NRM) is defined as death occurring in a patient from causes other than disease relapse or progression. Disease progression is the competing event for NRM.

    Measured: 1 Year

  4. Kaplan-Meier of Progression Free Survival

    Defined as progression of disease or death from any cause. Surviving patients without disease progression will be censored at the date of last contact.

    Measured: 1 Year

  5. Incidence of Cytokine Release Syndrome (CRS)

    Overall incidence of CRS of any grade and grade 3 or 4 CRS post CAR T-cell infusion will be reported on all patients.

    Measured: Day 4, Day 7, Day 10, Day 14, and Day 21 post-infusion

  6. Incidence of Prolonged Cytopenias

    Overall incidence of prolonged cytopenias will be reported. Prolonged cytopenia is defined as failure to achieve ANC greater than 500/mm3 or platelet count greater than 20,000/mm3(with or without support) by 30 days post CAR T-cell infusion.

    Measured: 1 Year

  7. Incidence of Neurotoxicity

    Overall incidence of CAR T-cell related neurotoxicity per the ASBMT immune effector cell associated neurotoxicity syndrome (ICANS) Consensus Grading.

    Measured: 1 Year

Timeline

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

  1. First posted2 Sep 2021
  2. Study start5 Jan 2022
  3. Primary completion22 Aug 2024
  4. Study completion20 Feb 2025

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Assess anti-B Cell Maturation Antigen(BCMA) chimeric antigen receptor (CAR) T-cells (bb2121) to improve post autologous hematopoietic cell transplant (HCT) responses among patients with multiple myeloma (MM).
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05032820
Sponsor's protocol ID
BMTCTN1902
Other IDs
2U10HL069294-11, 5U24CA076518
Status last verified
May 2026
First submitted
8 Jul 2021
Last updated
19 May 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Results will be published in a manuscript and supporting information submitted to NIH BioLINCC (including data dictionaries, case report forms, data submission documentation, documentation for outcomes dataset, etc., where indicated).

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Lenalidomide, bb2121 and Cyclophosphamide in people with Multiple Myeloma, run by Medical College of Wisconsin at 15 sites in United States.

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 22 inclusion and 34 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: finished, as of the sponsor's last update on 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Efficacy of BCMA CAR-T Cell Therapy (time frame: 6 months). 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 NCT05032820.

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 19 May 2026; AzTrials last refreshed its copy on 6 Nov 2026.

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