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 74
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  • 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, 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. 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. Daratumumab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Giving lenalidomide and dexamethasone with daratumumab may work better in treating patients with smoldering myeloma.
    Location: 554 locations

  • 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: 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 (relapsed) or does not respond to treatment (refractory). 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, vincristine, 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: 389 locations

  • Testing the Use of Combination Therapy in Adult Patients with Newly Diagnosed Multiple Myeloma, the EQUATE Trial

    This phase III trial compares the combination of four drugs (daratumumab, bortezomib, lenalidomide and dexamethasone) to the use of a three-drug combination (daratumumab, lenalidomide and dexamethasone) in patients with newly diagnosed multiple myeloma. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Chemotherapy drugs, 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. Daratumumab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. 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. Adding bortezomib to daratumumab, lenalidomide, and dexamethasone may be more effective in shrinking the cancer or preventing it from returning, compared to continuing on a combination of daratumumab, lenalidomide, and dexamethasone in patients with newly diagnosed multiple myeloma.
    Location: 45 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: 24 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: 29 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, 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. 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. 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

  • 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: 10 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: 10 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, use substances made from living organisms that may stimulate or suppress the immune system in different ways and stop cancer cells from growing. Blinatumomab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread.
    Location: 12 locations

  • A Study of Health-Related Quality of Life in Patients with Multiple Myeloma Receiving Daratumumab or Lenalidomide

    This phase II trial compares daratumumab and lenalidomide as maintenance therapy in treating patients with multiple myeloma. Daratumumab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Monoclonal antibodies target and destroy only certain cells in the body. This selective targeting may help protect healthy cells from damage. Lenalidomide is an immunomodulatory drug that works against cancer cells by helping to change or control the functioning of the immune system. This trial is being done to compare the usual maintenance therapy (lenalidomide) versus daratumumab as maintenance therapy, to see if one is better than the other, how they affect multiple myeloma, which drug gives patients a better health-related quality of life during treatment, and if one is easier to take than the other.
    Location: 7 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

  • 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 belantamab mafodotin 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 will be a dose escalation phase to evaluate the safety and tolerability of up to 3 dose levels and up to 2 dosing schedules of belantamab mafodotin in combination with the two standard of care (SoC) regimens. Part 2 will further evaluate the safety and preliminary clinical activity of belantamab mafodotin at selected dose levels and dosing schedules in combination with Len / Dex or Bor / Dex. A total of 152 evaluable participants will be enrolled in the study with up to 27 in Part 1 and up to 125 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, death or end of study. 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 belantamab mafodotin, as a monotherapy until the occurrence of PD, intolerable AEs, consent withdrawal, death or end of study.
    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

  • Selinexor and Backbone Treatments of Multiple Myeloma Patients

    This study will independently assess the efficacy and safety of 10 combination therapies in 11 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) - Arm 10: Selinexor + dexamethasone + belantamab mafodotin (SBd) - Arm 11: Selinexor + dexamethasone + pomalidomide + daratumumab (SDPd) 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], Arm 10 [SBd], and Arm 11 [SDPd]) 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 to Evaluate the Safety of bb2121 in Subjects With High Risk, Newly Diagnosed Multiple Myeloma (NDMM)

    This is a multicenter, open-label, phase 1, single arm study intended to determine the optimal target dose and safety of bb2121 in subjects with HR (R-ISS Stage III per IMWG criteria) NDMM. Subjects should have received 3 Cycles of standard induction therapy prior to undergoing leukapheresis procedure to collect autologous mononuclear cells for manufacture of the drug product (bb2121). Following manufacture of the drug product, subjects will receive fourth cycle of induction therapy followed by lymphodepleting therapy with fludarabine and cyclophosphamide prior to bb2121 infusion. Maintenance therapy is recommended for all subjects who have received bb2121 infusion and should be initiated upon adequate bone marrow recovery or from 90-day post-bb2121 infusion, whichever is later.
    Location: 8 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: 6 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

  • 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

  • Carfilzomib, Lenalidomide, Dexamethasone, and Isatuximab for the Treatment of Newly Diagnosed, Transplant-Eligible Multiple Myeloma

    This phase II trial investigates how well carfilzomib, lenalidomide, dexamethasone, and isatuximab work in treating patients with newly diagnosed multiple myeloma who are eligible for a transplant. Carfilzomib may work by inhibiting (blocking) multiple myeloma cells from breaking down proteins within the cells, causing a buildup of proteins within multiple myeloma cells, that may lead to cell death. Lenalidomide may work in many ways of attacking tumor cells including activating the immune system against the tumor, and increasing tumor cell death, and decreasing tumor blood vessel growth. Anti-inflammatory drugs, such as dexamethasone lower the body’s immune response and are used with other drugs to treat and kill some types of cancer. Isatuximab is a monoclonal antibody. An antibody is a protein produced in the blood to fight diseases by attacking and killing harmful foreign organisms such as bacteria and viruses. In some diseases, like cancer, the antibody will protect the patient by attaching itself to a target molecule inside the body, which is also a protein. Isatuximab will attach itself to a protein called CD38 located on the surface of immune cells and some cancer cells in the body and can induce the killing of those cells. Giving carfilzomib, lenalidomide, dexamethasone, and isatuximab may help treat patients with multiple myeloma.
    Location: 4 locations


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