Clinical Trials Using Lenalidomide

Clinical trials are research studies that involve people. The clinical trials on this list are studying Lenalidomide. All trials on the list are supported by NCI.

NCI’s basic information about clinical trials explains the types and phases of trials and how they are carried out. Clinical trials look at new ways to prevent, detect, or treat disease. You may want to think about taking part in a clinical trial. Talk to your doctor for help in deciding if one is right for you.

Trials 1-25 of 77
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  • Testing the Addition of a New Drug, Daratumumab / rHuPH20, to the Usual Treatment (Lenalidomide) as Post-stem Cell Transplant Treatment for Multiple Myeloma, DRAMMATIC Study

    This phase III trial compares the effect of usual treatment (lenalidomide) to using daratumumab / rHuPH20 plus the usual treatment after stem cell transplantation in patients with multiple myeloma. This drug combination may help patients live longer after their stem cell transplant. Another purpose of this study is to learn if the presence and amount of minimal residual disease (MRD) can help doctors predict when a patient’s multiple myeloma will get worse. MRD is the name for the small number of cancer cells that remain in the patient even after their multiple myeloma has been treated and they have no symptoms of the disease. Drugs used in chemotherapy, such as lenalidomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with daratumumab / rHuPH20, may induce changes in body’s immune system and may interfere with the ability of tumor cells to grow and spread. Giving lenalidomide and daratumumab / rHuPH20 may work better in treating patients with multiple myeloma compared to lenalidomide alone.
    Location: 500 locations

  • Lenalidomide, and Dexamethasone with or without Daratumumab in Treating Patients with High-Risk Smoldering Myeloma

    This phase III trial studies how well lenalidomide and dexamethasone works with or without daratumumab in treating patients with high-risk smoldering myeloma. Drugs used in chemotherapy, such as lenalidomide and dexamethasone, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as daratumumab, may induce changes in the body's immune system and may interfere with the ability of tumor cells to grow and spread. Giving lenalidomide and dexamethasone with daratumumab may work better in treating patients with smoldering myeloma.
    Location: 506 locations

  • Obinutuzumab with or without Umbralisib, Lenalidomide, or Combination Chemotherapy in Treating Patients with Relapsed or Refractory Grade I-IIIa Follicular Lymphoma

    This randomized phase II trial studies how well obinutuzumab with or without umbralisib, lenalidomide, or combination chemotherapy work in treating patients with grade I-IIIa follicular lymphoma that has come back or does not respond to treatment. Immunotherapy with obinutuzumab, may induce changes in body’s immune system and may interfere with the ability of tumor cells to grow and spread. Umbralisib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Biological therapies, such as lenalidomide, use substances made from living organisms that may stimulate or suppress the immune system in different ways and stop cancer cells from growing. Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, prednisone, and bendamustine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether giving obinutuzumab with or without umbralisib, lenalidomide, or combination chemotherapy will work better in treating patients with grade I-IIIa follicular lymphoma.
    Location: 384 locations

  • Efficacy and Safety Study of bb2121 Versus Standard Regimens in Subjects With Relapsed and Refractory Multiple Myeloma (RRMM)

    This is a multicenter, randomized, open-label, Phase 3 study comparing the efficacy and safety of bb2121 versus standard regimens in subjects with relapsed and refractory multiple myeloma (RRMM). The study is anticipated to randomize approximately 381 subjects with RRMM. Approximately 254 subjects will be randomized to Treatment Arm A and approximately 127 subjects will be randomized to Treatment Arm B.
    Location: 27 locations

  • A Study of Daratumumab Plus Lenalidomide Versus Lenalidomide Alone as Maintenance Treatment in Participants With Newly Diagnosed Multiple Myeloma Who Are Minimal Residual Disease Positive After Frontline Autologous Stem Cell Transplant

    The purpose of this study is to evaluate conversion rate to minimal residual disease (MRD) negativity following the addition of daratumumab to lenalidomide relative to lenalidomide alone, when administered as maintenance treatment to anti-cluster of differentiation 38 (CD38) treatment naive participants with newly diagnosed multiple myeloma who are MRD positive as determined by next generation sequencing (NGS) following high-dose therapy (HDT) and autologous stem cell transplant (ASCT), with or without consolidation therapy.
    Location: 20 locations

  • Carfilzomib, Lenalidomide, Dexamethasone, Daratumumab, Melphalan, and Stem Cell Transplant in Treating Patients with Relapsed or Refractory Multiple Myeloma

    This phase II trial studies how well carfilzomib, lenalidomide, dexamethasone, daratumumab, melphalan, and stem cell transplant work in treating patients with multiple myeloma that has come back (relapsed) or does not respond to treatment (refractory). Drugs used in chemotherapy, such as carfilzomib, lenalidomide, dexamethasone, and melphalan, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as daratumumab, may help the body’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving chemotherapy before a stem cell transplant helps kill any cancer cells that are in the body and helps make room in the patient’s bone marrow for new blood-forming cells (stem cells) to grow. After treatment, stem cells are collected from the patient's and stored. More chemotherapy is then given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy. Giving carfilzomib, lenalidomide, dexamethasone, daratumumab, melphalan, and stem cell transplant may work better in treating patients with multiple myeloma.
    Location: 13 locations

  • R-ICE and Lenalidomide in Treating Patients with First-Relapse / Primary Refractory Diffuse Large B-Cell Lymphoma

    This phase I / II trial studies the side effects and best dose of lenalidomide when given together with rituximab-ifosfamide-carboplatin-etoposide (R-ICE) and to see how well they work in treating patients with diffuse large B-cell lymphoma that has returned after a period of improvement (relapsed) and that has not responded to previous treatment (refractory). Drugs used in chemotherapy, such as rituximab, ifosfamide, carboplatin, etoposide, and lenalidomide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving lenalidomide with R-ICE may be a better treatment for patients with diffuse large B-cell lymphoma.
    Location: 11 locations

  • Study of Acalabrutinib Alone or in Combination Therapy in Subjects With B-cell Non-Hodgkin Lymphoma

    Part 1: To characterize the safety profile of acalabrutinib alone or in combination with rituximab in subjects with R / R FL. Part 2: To characterize the activity of acalabrutinib alone or in combination with rituximab in subjects with R / R MZL, as measured by ORR. Part 3: To characterize the safety of acalabrutinib in combination with rituximab and lenalidomide in subjects with R / R FL
    Location: 11 locations

  • Immunotherapy of Relapsed Refractory Neuroblastoma With Expanded NK Cells

    This NANT trial will determine the maximum tolerated dose (MTD) of autologous expanded natural killer (NK) cells when combined with standard dosing of ch14.18 and will assess the feasibility of adding lenalidomide at the recommended Phase II dose of the expanded NK cells with ch14.18, for treatment of children with refractory or recurrent neuroblastoma.
    Location: 9 locations

  • Daratumumab, Carfilzomib, Lenalidomide, and Dexamethasone for the Treatment of Newly Diagnosed Multiple Myeloma

    This phase II trial compares the safety and activity of the combination of carfilzomib, lenalidomide, and dexamethasone (KRD), or carfilzomib, lenalidomide, dexamethasone and daratumumab (KRD+DARA) with the usual treatment composed of lenalidomide, bortezomib and dexamethasone (VRD) for the treatment of newly diagnosed multiple myeloma. Immunotherapy with daratumumab, may induce changes in body’s immune system and may interfere with the ability of tumor cells to grow and spread. Carfilzomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Lenalidomide may help the immune system kill abnormal blood cells or cancer cells. It may also prevent the growth of new blood vessels that tumors need to grow. Anti-inflammatory drugs such as dexamethasone lower the body’s immune response and are used with other drugs in the treatment of some types of cancer. This study will measure the amount of myeloma cells that remain in the body after treatment with the study drugs, described as minimal residual disease (MRD). Studies show that having no remaining multiple myeloma cells or a low number of these cells (MRD negativity) is associated with better clinical outcomes. This study compares the results of the usual treatment (VRD) with those of KRD or KRD+DARA to see which treatment is safer and results in more patients achieving MRD negativity.
    Location: 7 locations

  • A Study of Lenalidomide and CC-486 with Radiation Therapy for the Treatment of Plasmacytoma, LENZART Study

    This trial studies how well lenalidomide, CC-486 and radiation therapy work for the treatment of plasmacytoma. Drugs used in chemotherapy, such as lenalidomide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. CC-486 is an oral form of the drug azacitidine. CC-486 works by changing the proteins produced by the cancer cells which, when CC-486 is combined with other cancer drugs, may make the cancer cells more likely to die. Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Giving lenalidomide, CC-486 and radiation therapy may boost the immune system’s ability to identify and destroy cancer cells, which could prevent plasmacytoma from developing into multiple myeloma or prevent multiple myeloma from getting worse (progressing).
    Location: 7 locations

  • Safety and Efficacy of Axicabtagene Ciloleucel in Combination With Either Rituximab or Lenalidomide in Participants With Refractory Large B-Cell Lymphoma

    The primary objective of this study is to estimate the efficacy of axicabtagene ciloleucel in combination with either rituximab or lenalidomide, as measured by assessment of response rates in adult participants with relapsed / refractory large B-cell lymphoma.
    Location: 8 locations

  • Ibrutinib, Rituximab, and Lenalidomide in Treating Patients with Refractory or Recurrent, Primary or Secondary Central Nervous System Lymphoma

    This phase Ib trial studies the side effects and best dose of ibrutinib when given together with rituximab and lenalidomide in treating patients with primary or secondary central nervous system lymphoma that has come back (recurrent) or does not respond to treatment (refractory). Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Rituximab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as lenalidomide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. This study is being done to find out if giving ibrutinib, rituximab, and lenalidomide is safer and works better in treating patients with primary or secondary central nervous system lymphoma compared to standard treatment.
    Location: 7 locations

  • To Evaluate Safety, Tolerability, and Clinical Activity of the Antibody-drug Conjugate, GSK2857916 Administered in Combination With Lenalidomide Plus Dexamethasone (Arm A), or in Combination With Bortezomib Plus Dexamethasone (Arm B) in Participants With Relapsed / Refractory Multiple Myeloma (RRMM)

    This study will evaluate the safety and tolerability profile of GSK2857916 when administered in combination with approved regimens of either Lenalidomide Plus Dexamethasone [Len / Dex (Arm A)] or Bortezomib Plus Dexamethasone [Bor / Dex (Arm B)] in participants with RRMM, i.e., those who have relapsed or who are refractory to at least 1 line of approved therapy. Part 1 of the study is a dose escalation phase to evaluate the safety and tolerability of up to 3 dose levels and up to 2 dosing schedules of GSK2857916 in combination with the two standard of care (SoC) regimens. Part 2 will further evaluate the safety and preliminary clinical activity of GSK2857916 at selected dose levels and dosing schedules in combination with Len / Dex or Bor / Dex. Up to a total of 123 evaluable participants will be enrolled in the study with up to 33 Part 1 and up to 90 in Part 2. Participants receiving treatment Arm A, may continue combination treatment until the occurrence of progressive disease (PD), intolerable adverse events (AEs ), consent withdrawal, or death. The participants receiving treatment Arm B, may continue combination treatment for a total of up to 8 cycles. After 8 cycles of combination therapy, the participants will continue treatment with GSK2857916, as a monotherapy until the occurrence of PD, intolerable AEs, consent withdrawal, or death.
    Location: 7 locations

  • Daratumumab and Lenalidomide in Treating Patients with Minimal Residual Disease Positive Multiple Myeloma after Induction Therapy with or without High-Dose Chemotherapy with Stem Cell Support

    This phase II trial studies how well daratumumab and lenalidomide work in treating patients with minimal residual disease positive multiple myeloma after initial chemotherapy (induction therapy) with or without high-dose chemotherapy with stem cell transplant (stem cell support). Immunotherapy with daratumumab, may induce changes in body’s immune system and may interfere with the ability of tumor cells to grow and spread. Lenalidomide works against cancer cells partly by impacting the functioning of the immune system. Giving daratumumab and lenalidomide may work better in treating patients with MRD positive multiple myeloma.
    Location: 7 locations

  • Lenalidomide and Blinatumomab for the Treatment of Relapsed Non-Hodgkin Lymphoma

    This phase I trial studies the side effects and best dose of lenalidomide and blinatumomab when given together in treating patients with non-Hodgkin lymphoma that has returned after a period of improvement (relapsed). Biological therapies, such as lenalidomide and blinatumomab, use substances made from living organisms that may stimulate or suppress the immune system in different ways and stop cancer cells from growing.
    Location: 12 locations

  • Selinexor and Backbone Treatments of Multiple Myeloma Patients

    This study will independently assess the efficacy and safety of 8 combination therapies in 9 arms, in dose-escalation / -evaluation and expansion phases, for the treatment of patients with relapsed / refractory multiple myeloma (RRMM) and newly diagnosed multiple myeloma (NDMM). The combinations to be evaluated are: - Arm 1: Selinexor + dexamethasone + pomalidomide (SPd) - Arm 2: Selinexor + dexamethasone + bortezomib (SVd); enrollment complete - Arm 3: Selinexor + dexamethasone + lenalidomide (SRd) in RRMM; enrollment complete - Arm 4: Selinexor + dexamethasone + pomalidomide + bortezomib (SPVd) - Arm 5: Selinexor + dexamethasone + daratumumab (SDd); enrollment complete - Arm 6: Selinexor + dexamethasone + carfilzomib (SKd) - Arm 7: Selinexor + dexamethasone + lenalidomide (SRd) in NDMM - Arm 8: Selinexor + dexamethasone + ixazomib (SNd) - Arm 9: Selinexor + dexamethasone + pomalidomide + elotuzumab (SPEd) Selinexor pharmacokinetics: - PK Run-in (Days 1-14): Starting in protocol version 8.0, patients enrolled to any arm in the Dose Escalation Phase (i.e., Arm 4 SPVd, Arm 6 SKd, Arm 8 SNd, Arm 9 SPEd) will also first be enrolled to a pharmacokinetics (PK) Run-in period until 9 patients have been enrolled to this period to evaluate the PK of selinexor before and after co-administration with a strong CYP3A4 inhibitor.
    Location: 7 locations

  • A Study of JNJ-68284528, a Chimeric Antigen Receptor T Cell (CAR-T) Therapy Directed Against B-cell Maturation Antigen (BCMA) in Participants With Multiple Myeloma

    The purpose of this study is to evaluate the overall minimal residual disease (MRD) negative rate of participants who receive JNJ-68284528.
    Location: 7 locations

  • Dexamethasone, Lenalidomide, Carfilzomib, and Daratumumab in Treating Participants with Multiple Myeloma

    This phase II trial studies how well dexamethasone, lenalidomide, carfilzomib, and daratumumab work in treating participants with multiple myeloma. Drugs used in chemotherapy, such as dexamethasone, lenalidomide, and carfilzomib, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as daratumumab, may interfere with the ability of cancer cells to grow and spread. Giving dexamethasone, lenalidomide, carfilzomib, and daratumumab may work better in treating participants with multiple myeloma.
    Location: 5 locations

  • Mitoxantrone, Etoposide, Cytarabine, and Lenalidomide in Treating Patients with Relapsed or Refractory Acute Myeloid Leukemia

    This phase II trial studies how well mitoxantrone, etoposide, cytarabine, and lenalidomide work in treating patients with acute myeloid leukemia that has come back or does not respond to treatment. Drugs used in chemotherapy, such as mitoxantrone, etoposide, cytarabine, and lenalidomide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.
    Location: 5 locations

  • Citarinostat and PVX-410 with or without Lenalidomide in Treating Patients with Smoldering Multiple Myeloma

    This phase Ib trial studies the side effects of HDAC inhibitor ACY-241 (citarinostat) and XBP1-US / XBP1-SP / CD138 / CS1 multipeptide vaccine PVX-410 (PVX-410) with or without lenalidomide in treating patients with smoldering multiple myeloma. Citarinostat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Vaccine therapy, such as PVX-410, may help the body build an effective immune response to kill cancer cells. Biological therapies, such as lenalidomide, use substances made from living organisms that may stimulate or suppress the immune system in different ways and stop cancer cells from growing. Giving citarinostat and PVX-410 with or without lenalidomide may work better in treating patients with smoldering multiple myeloma.
    Location: 5 locations

  • Aggressive Smoldering Curative Approach Evaluating Novel Therapies and Transplant

    This study evaluates the use of carfilzomib, lenalidomide, daratumumab, and dexamethasone in subjects with high-risk smoldering multiple myeloma (SMM). Subjects will receive treatment in 3 phases - induction (6 cycles), consolidation (6 cycles), and maintenance (12 cycles). Each cycle is 28 days.
    Location: 6 locations

  • Lenalidomide, Dexamethasone, and Elotuzumab in Treating Patients with Relapsed Primary Amyloidosis

    This randomized phase II trial studies how well lenalidomide, dexamethasone, and elotuzumab work in treating patients with primary amyloidosis that has come back after a period of improvement (relapsed). Drugs used in chemotherapy, such as lenalidomide and dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with elotuzumab may induce changes in body’s immune system and may interfere with the ability of tumor cells to grow and spread. Giving lenalidomide, dexamethasone, and elotuzumab may work better in treating patients with primary amyloidosis.
    Location: 5 locations

  • NFKB2 Rearrangement in Guiding Treatment with Ixazomib Citrate and Dexamethasone or Ixazomib Citrate, Dexamethasone and Lenalidomide in Patients with Relapsed or Refractory Multiple Myeloma

    This randomized phase II trial studies how well ixazomib citrate and dexamethasone or ixazomib citrate, dexamethasone, and lenalidomide work based on the expression of a gene called nuclear factor of kappa light polypeptide gene enhancer in B-cells 2 (NFKB2) in treating patients with multiple myeloma that has returned after a period of improvement or does not respond to treatment. Ixazomib citrate may stop the growth of cancer cells by blocking enzymes called proteasomes needed for cell growth. Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Lenalidomide may stimulate the immune system against cancer cells and may also prevent the growth of new blood vessels that tumors need to grow. It is not yet known whether ixazomib citrate and dexamethasone, or ixazomib citrate, dexamethasone, and lenalidomide are more effective in treating multiple myeloma.
    Location: 4 locations

  • Lenalidomide with or without Carfilzomib and Dexamethasone in Treating Patients with Multiple Myeloma after Stem-Cell Transplant

    This randomized phase III trial studies how well lenalidomide with or without carfilzomib and dexamethasone works in treating patients with multiple myeloma after stem-cell transplant. Lenalidomide may help the immune system kill abnormal blood cells or cancer cells. It may also prevent the growth of new blood vessels that tumors need to grow. Carfilzomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Dexamethasone is a drug used to reduce inflammation and lower the body’s immune response. Giving lenalidomide together with carfilzomib and dexamethasone may be an effective treatment for multiple myeloma.
    Location: 3 locations


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