Nicotinamide Expanded Haploidentical or Mismatched Related Donor Natural Killer Cells for Multiple Myeloma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Masonic Cancer Center, University of Minnesota, Minneapolis, MN
Multiple Myeloma+14 More
Nicotinamide Expanded Haploidentical or Mismatched Related Donor Natural Killer Cells - Biological
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a new type of immune cell therapy can be used to treat people with multiple myeloma or non-Hodgkin lymphoma.

See full description

Eligible Conditions

  • Multiple Myeloma
  • Indolent B Cell Lymphoma
  • Diffuse Large B-Cell Lymphoma (DLBCL)
  • Non-Hodgkin's Lymphoma (NHL)
  • Lymphoplasmacytic Lymphoma
  • Follicular Lymphoma ( FL)
  • Primary Mediastinal Lymphoma
  • Mantle Cell Lymphoma (MCL)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Multiple Myeloma

Study Objectives

This trial is evaluating whether Nicotinamide Expanded Haploidentical or Mismatched Related Donor Natural Killer Cells will improve 2 primary outcomes and 3 secondary outcomes in patients with Multiple Myeloma. Measurement will happen over the course of 24 hours post infusion.

1 year post infusion
Number of patients alive without progression
2 months post infusion
Occurrence of treatment related mortality (TRM)
24 hours post infusion
Occurrence of any grade 4 or greater suspected adverse reaction
28 days post infusion
Occurrence of Grade III or IV acute graft-versus-host disease (aGVHD)
Occurrence of disease response

Trial Safety

Safety Progress

1 of 3

Other trials for Multiple Myeloma

Trial Design

2 Treatment Groups

Non-Hodgkin Lymphoma
1 of 2
Multiple Myeloma
1 of 2
Experimental Treatment

This trial requires 24 total participants across 2 different treatment groups

This trial involves 2 different treatments. Nicotinamide Expanded Haploidentical Or Mismatched Related Donor Natural Killer Cells is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

Non-Hodgkin Lymphoma
Biological
After a lymphodepleting preparative regimen of cyclophosphamide and fludarabine, patients receive expanded NAM-NK cells followed by a short course of interleukin-2 (IL-2) to facilitate natural killer cell survival and expansion in vivo. Monoclonal antibodies and rituximab for Non-Hodgkin Lymphoma patients, will be administered prior to and after the natural killer cell infusion(s) to facilitate tumor targeting and antibody dependent cellular cytotoxicity (ADCC).
Multiple Myeloma
Biological
After a lymphodepleting preparative regimen of cyclophosphamide and fludarabine, patients receive expanded NAM-NK cells followed by a short course of interleukin-2 (IL-2) to facilitate natural killer cell survival and expansion in vivo. Monoclonal antibodies and elotuzumab for Multiple Myeloma patients, will be administered prior to and after the natural killer cell infusion(s) to facilitate tumor targeting and antibody dependent cellular cytotoxicity (ADCC).

Trial Logistics

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 1 year post infusion
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 1 year post infusion for reporting.

Closest Location

Masonic Cancer Center, University of Minnesota - Minneapolis, MN

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Multiple Myeloma or one of the other 14 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
≥18 to ≤70 years of age
relapsed/refractory disease after two lines of therapies, including a proteasome inhibitor (bortezomib, carfilzomib or ixazomib) and an immunomodulatory drug (thalidomide, lenalidomide or pomalidomide)
relapsed disease between 2-18 months of 1st autologous stem cell transplantation
relapsed disease at least 4 months after allogeneic stem cell transplantation with no evidence of active graft versus host disease and no availability of donor lymphocyte infusion
measurable disease defined as serum IgG, A, M M-protein ≥ 0.5g/dL or serum IgD M-protein ≥ 0.5 g/dL, or urine M-protein ≥ 200 mg/24 hours
at least 4 weeks since plasmapheresis
at least 3 days between last corticosteroids and study treatment start
CD20-positive B-cell Non-Hodgkin Lymphoma (NHL)
evidence of relapsed/refractory disease that has failed conventional therapy and failed/not eligible/refused studies of a higher priority
relapsed disease at least 60 days after autologous stem cell transplantation

Patient Q&A Section

What are the chances of developing multiple myeloma?

"People in New Hampshire are more likely to be diagnosed after the age of 70 than after the age of 50. Rates are generally higher in women than in men; however, when diagnosed before the age of 80, men are more likely than women to reach this age by the time they are diagnosed, and some have the longest interval between first diagnosis and subsequent diagnosis of multiple myeloma." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in nicotinamide expanded haploidentical or mismatched related donor natural killer cells for therapeutic use?

"Although both CD19CAR T-cells and CEMCAR T-cells induced cytotectonic effects in a preclinical study with a myeloma model system, CD19CAR T-cells were less immunoreactive and more cytotoxic in vitro. These preclinical findings suggest that CD19CAR T-cells, if expanded from these same donors, may prove to be a potential therapeutic tool for relapsed MM." - Anonymous Online Contributor

Unverified Answer

What are common treatments for multiple myeloma?

"A combination of chemotherapy, supportive care, and, rarely, autologous stem cell transplantation are the treatments most often used to treat MM. As an example of supportive care, blood transfusion is the most common treatment for MM and it is the first line treatment for anyone with symptomatic anemia." - Anonymous Online Contributor

Unverified Answer

How many people get multiple myeloma a year in the United States?

"Most people diagnosed with multiple myeloma develop the disease while aging, especially from 45 to 64 years of age. Results from a recent paper provides new data about the disease incidence in men and women. The majority of people diagnosed with multiple myeloma reside in the Northeast of the United States." - Anonymous Online Contributor

Unverified Answer

Can multiple myeloma be cured?

"In the majority of patients, very mild myeloma can be effectively managed by careful chemotherapy with no long-term toxicity. However, a subgroup of myeloma patients require intensive chemotherapy that has a good response rate. These intensively treated patients appear to have a better prognosis because they have a low tumor burden at initial presentation than other patients who are receiving less intensive treatment. As myeloma progresses, aggressive multimodal therapy is needed. Because the tumors are usually less viable afterwards, this gives these patients the best chance of long-term survival with fewer treatment-related complications." - Anonymous Online Contributor

Unverified Answer

What are the signs of multiple myeloma?

"Multiple myeloma is an elusive disease, which results in variable clinical signs and symptoms. A variety of clinical observations can help to identify MM, but the most specific sign is plasma cell myeloma, which usually causes anemia (due to abnormal bone marrow production of protein) and hypercalcemic (slightly elevated calcium levels) disturbances. The bone marrow aspirate, if performed carefully, can help clinicians to diagnose MM. In the setting of the present investigation, bone marrow aspirate did not show evidence of MM, but it was suggestive of it." - Anonymous Online Contributor

Unverified Answer

What causes multiple myeloma?

"Multiple myeloma may result from a number of biological events and thus can occur in unrelated individuals. Some of these events are likely to involve exposures to environmental carcinogens and lifestyle factors." - Anonymous Online Contributor

Unverified Answer

What is multiple myeloma?

"In the first issue of this issue, Dr Peter Vidal outlines the main challenges that he currently faces as a newly-appointed chair of the World Myeloma Organization and how he is trying to overcome these. In addition, Dr. Vidal highlights the recent findings regarding myelodysplastic syndromes and how they might be helpful in our understanding of the heterogeneity between the disease's clinical and biological features. As Dr. Mark H. Farber explains in the second issue, it is clear that there are more possibilities for treating myeloma than using chemotherapy or other traditional therapies." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of nicotinamide expanded haploidentical or mismatched related donor natural killer cells?

"The common side effects of NK cells after transplantation including the GVHD syndrome were mild. However, the common side effects associated with AMRD transplantation including fever, diarrhea, and nausea persisted for several days." - Anonymous Online Contributor

Unverified Answer

Has nicotinamide expanded haploidentical or mismatched related donor natural killer cells proven to be more effective than a placebo?

"Nicotinamide expanded NK cells, even a minimal donor expansion of five to seven, have higher rates of cytotoxicity and function against CM/GvHD-like allogeneic hematopoietic progenitor cells than do expanded haploidentical NK cells in the same study. There is also a more rapid return of normal blood counts and hematopoiesis to baseline levels." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets multiple myeloma?

"Multiple myeloma usually begins either at around the age of 70 or at much earlier. However, these data suggest that the average age of onset of primary multiple myeloma is closer to the mid-twenties at which the disease is more common. Since the rate of multiple myeloma increases steadily with age, this age distribution should be taken into account when informing patients on multiple myeloma." - Anonymous Online Contributor

Unverified Answer

Is nicotinamide expanded haploidentical or mismatched related donor natural killer cells typically used in combination with any other treatments?

"We demonstrated that NK-MHD/MR-donor NK cells combined with anthracyclines or ASCT could efficiently eradicate MM xenografts. Findings from a recent study are highly encouraging and support the clinical use of NK-MHD/MR-MNCs for the treatment of MM." - Anonymous Online Contributor

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