CLINICAL TRIAL

Lenalidomide and bb2121 for Multiple Myeloma

Grade I
Waitlist Available · 18+ · All Sexes · Palo Alto, CA

This study is evaluating whether a new type of treatment for multiple myeloma can improve the success of autologous hematopoietic cell transplant.

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About the trial for Multiple Myeloma

Treatment Groups

This trial involves 2 different treatments. Lenalidomide And Bb2121 is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Lenalidomide and bb2121
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

Eligibility

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Patients must have initiated maintenance therapy with lenalidomide within 6 months after the auto HCT and have received at least 6 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 toxicities.
Patients must meet the criteria for symptomatic MM requiring therapy (Appendix A) prior to initiating initial systemic anti-myeloma treatment.
Age greater than or equal to 18.00 years and less than 71.00 years
Patients must have received initial systemic anti- myeloma therapy consisting of induction therapy and consolidation with high-dose melphalan (>140 mg/m2 ) followed by an auto HCT (minimum cell dose of 2x106 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 2x106 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 achieved less than a VGPR (Section 3.1) in reference to time of initiation of initial systemic anti-myeloma therapy1 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.
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 1 Year
Screening: ~3 weeks
Treatment: Varies
Reporting: 1 Year
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 1 Year.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Lenalidomide and bb2121 will improve 2 primary outcomes, 13 secondary outcomes, and 15 other outcomes in patients with Multiple Myeloma. Measurement will happen over the course of 1 Year.

Best Disease Response
1 YEAR
: 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
1 YEAR
Prolonged Cytopenias
1 YEAR
Overall incidence of prolonged cytopenias will be reported. Prolonged cytopenia is defined as failure to achieve ANC greater than 500/mm^3 or platelet count greater than 20,000/mm^3(with or without support) by 30 days post CAR T-cell infusion.
1 YEAR
Immune Reconstitution
1 YEAR
The cellular composition of marrow (T-Cells, B-Cells, Natural Killer Cells, dendritic cells, and myeloid derived suppressor cells) will be quantified at the specified timepoints by flow cytometry.
1 YEAR
Cytokine Release Syndrome
1 YEAR
Overall incidence of CRS of any grade and grade 3 or 4 CRS post CAR T-cell infusion will be reported on all patients.
1 YEAR
Incidence of Infections
1 YEAR
Incidence of definite and probable viral, fungal and bacterial infections will be tabulated for each patient.
1 YEAR
Incidence of toxicities greater than or equal to grade 3 per the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
1 YEAR
All Grade 3 or higher toxicities will be tabulated. The proportion of patients experiencing cytokine release syndrome CRS will be reported including overall and grades 3-4 based on the ASTCT grading.
1 YEAR
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Patient Q & A Section

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

Is lenalidomide and bb2121 safe for people?

There was no significant difference in neutropenia rates between the two groups when compared at week 14 of treatment. Recent findings In a recent study suggest that bb2121 is as safe as lenalidomide +/- dexamethasone in patients with relapsed multiple myeloma who received prior chemotherapy.

Anonymous Patient Answer

Is lenalidomide and bb2121 typically used in combination with any other treatments?

Lenalidomide and bb2121 are frequently used in combination with other agents. A minority of patients are enrolled in clinical trials of lenalidomide; however, more than 90% of patients treated with lenalidomide are enrolled in clinical trials of bb2121. A larger proportion of patients receiving bb2121 have received other therapy than lenalidomide.

Anonymous Patient Answer

Who should consider clinical trials for multiple myeloma?

Clinical trials provide important information for patients about their disease and treatment options. A multidisciplinary approach involving all relevant clinicians is crucial if patients are to make informed decisions about clinical trials.

Anonymous Patient Answer

What is lenalidomide and bb2121?

The combination of lenalidomide and bb2121 resulted in better response rates compared to either agent alone. The safety profile was comparable between individuals receiving lenalidomide plus bb2121 or lenalidomide monotherapy. Lenalidomide plus bb2121 appears to provide a safe and effective option for the treatment of MM.

Anonymous Patient Answer

What is multiple myeloma?

Multiple myeloma involves both blood cells and bone marrow cells. The bone marrow cells go through a process called clonal selection and proliferation, which is what causes myeloma to grow. In order for myeloma to spread, it must be present in the bloodstream. This is why it affects both the blood and bone marrow. It is now believed that bone marrow cells are more important than blood cells when initiating and growing myeloma. However, this does not mean that there will never be any effect on the blood system. Current treatments do not allow for complete control of myeloma; therefore, there needs to be research in order to develop new methods of treating myeloma.

Anonymous Patient Answer

What does lenalidomide and bb2121 usually treat?

Patients with RR MM responded well to lenalidomide plus bb2121. The prominent role of bb2121 In a recent study supports its use in combination regimens for RR MM.

Anonymous Patient Answer

What are the latest developments in lenalidomide and bb2121 for therapeutic use?

The clinical data reported in this review support the use of lenalidomide with bortezomib for elderly patients with relapsed or refractory MM. These data also show that lenalidomide can be safely administered on an outpatient basis leading to the conclusion that lenalidomide with bortezomib is a rational regimen for treatment of elderly patients with relapsed or refractory MM.

Anonymous Patient Answer

Can multiple myeloma be cured?

There is no cure for MM. Treatment protocols should include chemotherapy, radiotherapy, and autologous stem cell transplantation (ASCT). Autologous stem cell transplantation was the most effective treatment strategy found In a recent study. The use of ASCT may help to reduce progression-free survival and overall survival in newly diagnosed MM patients. However, studies have shown that even in patients who receive ASCT, death from other causes occurs during the posttransplant period.

Anonymous Patient Answer

What are the common side effects of lenalidomide and bb2121?

Lenalidomide and bb2121 were associated with majority of the common adverse events. The safety profile of lenalidomide and bb2121 was similar to previous reports on lenalidomide monotherapy.

Anonymous Patient Answer

What causes multiple myeloma?

Multiple myeloma is a deadly and highly treatable disease, but unfortunately, only 50% of people diagnosed with multiple myeloma survive for five years after diagnosis.(https://www.withpower.com/myeloma-patient-support) In order to find the best possible treatment, it’s important that doctors develop a thorough understanding of the different factors that contribute to multiple myeloma's occurrence and progression. [Find the best clinical trial]\n

Anonymous Patient Answer

How serious can multiple myeloma be?

In a typical Caucasian population, MM affects about 2 people per 10,000 person-years. The median age at diagnosis is 63 years; median survival time is 8.2 years. In North America, MM occurs most commonly in elderly men, but has been reported in women and children. In Europe, MM tends to occur later in life and with lower survival rates. There is no clear relationship between race and presentation. MM occurs more frequently in African Americans than in Caucasians. The incidence of MM is increasing in some countries. This increase is similar to that observed for other types of cancers, possibly because it is related to lifestyle factors such as cigarette smoking and obesity.

Anonymous Patient Answer
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