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MyelomaPhase 1NCT01042704

Bendamustine in Combination With Lenalidomide and Dexamethasone in Refractory or Relapsed Multiple Myeloma

A Phase 1 study testing Bendamustine, Lenalidomide and Dexamethasone in people with Myeloma, run by Robert Redner, MD at 22 sites in United States.

Completed

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

Official record
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Trial summary

The purpose of this study is to see if the combination of bendamustine, lenalidomide and dexamethasone will help people with multiple myeloma that has returned after standard treatment or has been resistant to other treatments. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Myeloma
What is being tested?
Bendamustine, Lenalidomide and Dexamethasone
Could I receive a placebo?
No, everyone receives an active treatment
How many people
29 participants
Where
22 sitesUnited States
Study dates
Feb 2008to Mar 2015
Phase
Phase 1
Are there results?
None posted in the registry

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

  • Patients must have histologically or cytologically confirmed symptomatic Multiple Myeloma, Salmon-Durie Stage II or III or International Staging System II or III that has been previously treated with at least one cycle of a specific therapy; after which the patient has shown progressive or refractory disease, and must meet at least one of the following parameters of measurable disease:
  • Bone marrow plasmacytosis with > 10% plasma cells, or sheets of plasma cells, or biopsy proven plasmacytoma which must be obtained within 6 weeks prior to registration.
  • Measurable levels of monoclonal protein (M protein): > 1 g/dL of IgG or IgM M-protein or > 0.5 g/dL IgA or IgD M protein on serum protein electrophoresis OR > 200 mg of free light chain on a 24 hour urine protein electrophoresis which must be obtained within 4 weeks prior to registration OR > 20 mg/dL involved free light chain on serum free light chain testing with an abnormal kappa:lambda light chain ratio. Note that if both serum and urine m-components are present, both must be followed in order to evaluate response. Both SPEP and UPEP must be performed within 28 days prior to registration.
  • Patients with lytic bone disease, defined as at least one lytic lesion that can be accurately measured in at least one dimension.
  • Patients must have received prior chemotherapy for their myeloma, but not in the last 4 weeks. Patients may have previously received autologous peripheral blood stem cell transplantation. Prior treatment with lenalidomide is allowed.
  • Patients should not have received any radiation for the preceding 4 weeks before entry onto the study. Exception: local radiation therapy for symptomatic bone lesions (eg,uncontrolled pain or high risk of pathologic fracture)
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  • Age >= 18 years
  • Life expectancy of greater than 6 months.
  • ECOG performance status >=2 (Karnofsky >=60%). Patients with PS of 3 are eligible if their PS is due to pain, which would likely improve with treatment.
  • Patients must have normal organ and marrow function as defined below, obtained within 4 weeks prior to registration:
  • Hgb > 9 g/dL (which may be supported by transfusion or growth factors)
  • leukocytes >=2,000/ml
  • absolute neutrophil count ≥1000/ ml
  • platelets >=75,000/mcL
  • total bilirubin >=2.5 mg/dl
  • AST(SGOT)/ALT(SGPT) >=5 X institutional upper limit of normal
  • creatinine <2.5 mg/dl
  • Patients must not be pregnant or breast feeding. Due to the potential teratogenic properties of lenalidomide, the use of this drug in patients that are pregnant is absolutely contraindicated. Further, all women of childbearing potential and sexually active males must agree to avoid conception while participating in this study. Specifically, women of childbearing potential must either agree to refrain from sexual intercourse or employ a dual method of contraception, one of which is highly effective (IUD, birth control pills, tubal ligation or partners vasectomy), and another additional method (condom, diaphragm, or cervical cap) for 4 weeks prior to receiving lenalidomide, and for four weeks after discontinuing this therapy. Sexually active males cannot participate unless they agree to use a condom (even if they have undergone a prior vasectomy) while having intercourse with a woman of child bearing potential while taking lenalidomide and for four weeks after stopping treatment. Women of child bearing potential (those who have not had a hysterectomy or the absence of menstrual periods for at least 24 consecutive months) must have a negative pregnancy test 10-14 days prior to the initiation of therapy and a repeat negative pregnancy test 24 hours prior to the initiation of lenalidomide.
  • Ability to understand and the willingness to sign a written informed consent document. Patient must be informed of the investigational nature of this study.

Who cannot join

  • Patients who have had chemotherapy or radiotherapy within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier. Exception: local radiation therapy for symptomatic bone lesions (eg, uncontrolled pain or high risk of pathologic fracture)
  • Patients receiving any other investigational agents.
  • Patients with known brain metastases will be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
  • Patients with a history of allergic reactions attributed to compounds of similar chemical or biologic composition to lenalidomide and/or Bendamustine or other agents used in the study.
  • Patients with a second malignancy other than squamous/basal cell carcinoma of the skin or in situ carcinoma of the cervix unless the tumor was curatively treated at least two years previously.
  • Inability to comply with study and/or follow-up procedures.
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  • If a patient is on full-dose anticoagulants, the following criteria should be met for enrollment:
  • Must not have active bleeding or pathological conditions that carry high risk of bleeding (e.g. tumor involving major vessels, known varices).
  • Must have a platelet count >75,000.
  • Must have stable INR between 2-3.
  • Patients who have not collected hematopoietic progenitors and are potential candidates for autologous transplantation .
  • Patients that have a serious cardiac condition, such as myocardial infarction within 6 months or heart disease as defined by the New York Heart Association Class III or IV,
  • Patients with prior allogeneic stem cell transplant.
  • Non-secretory patients (i.e., patients who do not meet the minimum M-protein or light chain criteria)

Trial locations and contacts

22 sites in 1 country.

22 sites in 1 country

United States22 sites

  • UPMC Cancer Centers - Beaver

    Beaver, Pennsylvania, 15009

  • UPMC Cancer Centers - Jefferson

    Clairton, Pennsylvania, 15025

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • UPMC Cancer Centers - Arnold Palmer at Mountain View

    Greensburg, Pennsylvania, 15601

  • UPMC Cancer Centers - Arnold Palmer at Oakbrook

    Greensburg, Pennsylvania, 15601

  • UPMC Cancer Centers - Indiana

    Indiana, Pennsylvania, 15701

  • UPMC Cancer Centers - Johnstown

    Johnstown, Pennsylvania, 15901

  • Hematology-Oncology Associates of UPCI

    McKeesport, Pennsylvania, 15132

  • Hematology/Oncology - Private Practice

    McKeesport, Pennsylvania, 15132

  • UPMC Cancer Centers - Monroeville

    Monroeville, Pennsylvania, 15146

  • UPMC Cancer Centers - Arnold Palmer at Mt. Pleasant

    Mount Pleasant, Pennsylvania, 15666

  • UPMC Cancer Centers - New Castle

    New Castle, Pennsylvania, 16105

  • UPMC Cancer Centers - St. Margaret's

    Pittsburgh, Pennsylvania, 15215

  • UPMC Cancer Centers - Hillman Cancer Center

    Pittsburgh, Pennsylvania, 15232

  • UPMC Cancer Centers - Passavant

    Pittsburgh, Pennsylvania, 15237

  • VA Healthcare System - 646

    Pittsburgh, Pennsylvania, 15240

  • UPMC Cancer Centers - Drake

    Pittsburgh, Pennsylvania, 15241

  • UPMC Cancer Centers - Teramana Cancer Center

    Steubenville, Ohio, 43952

  • UPMC Cancer Centers - Uniontown

    Uniontown, Pennsylvania, 15401

  • UPMC Cancer Centers - Washington

    Washington, Pennsylvania, 15301

  • UPMC Cancer Centers - North Hills

    Wexford, Pennsylvania, 15090

  • UPMC Cancer Centers - Windber

    Windber, Pennsylvania, 15963

Other trials in United States

About this study

Official title: Phase I Study of Bendamustine in Combination With Lenalidomide (CC-5013) and Dexamethasone in Patients With Refractory or Relapsed Multiple Myeloma

The purpose of this study is to see if the combination of bendamustine, lenalidomide and dexamethasone will help people with multiple myeloma that has returned after standard treatment or has been resistant to other treatments.

Conditions
Myeloma
Being tested
Bendamustine, Lenalidomide, Dexamethasone, Aspirin, Prophylaxis
Keywords
Relapsed Myeloma, Refractory Myeloma
Medical subject headings
Neoplasms, Plasma Cell

What participants receive

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

  • BendamustineDrug

    Bendamustine is given intravenously (into a vein or IV infusion) on days 1 and 2 of each cycle. Each bendamustine infusion will take 60 minutes

  • LenalidomideDrug

    Lenalidomide is taken orally (by mouth) in the morning on days 1 through 21 of each cycle.

  • DexamethasoneDrug

    Dexamethasone is taken orally (by mouth) on days 1, 8, 15, and 22 of each cycle.

  • AspirinDrug

    All patients will receive enteric coated aspirin, 325 mg, QD while on study. If patient is unable to tolerate aspirin, patient should receive other types of anti-coagulation like Coumadin or low molecular weight heparin.

  • ProphylaxisDrug

    All patients will receive prophylaxis with either an H-2 blocker or proton pump inhibitor (PPI) while on study medications. Suggested medications included ranitidine 150 mg PC BID or omeprazole 20 mg PO QD or equivalent.

  • AntibioticDrug

    PCP antibiotic prophylaxis with a Bactrim will be recommended. In case of history of zoster or fungal infection a prophylaxis with Acyclovir or Diflucan should be also considered.

  • Biweekly Follow UpOther

    Vital signs (heart rate, breathing rate, blood pressure, and temperature) will be measured, and Blood tests to check CBC, Calcium, Electrolytes, serum, creatinine, and BUN. This follow up will take place at the Hillman Cancer Center, or whichever cancer center in which the subject is treated.

  • Cyclical Follow UpOther

    At the beginning of each treatment cycle subjects will undergo a Physical exam, a Performance status check, Recording of any new symptoms or side effects and any new medications, Blood tests (including blood chemistry, organ function and indicators of disease), Urine test, and pregnancy test (if applicable).

  • RestagingOther

    Every other cycle subjects' disease will be restaged. This will be accomplished by their treatment physician. Re-staging procedures includes a regular office visit, x-ray, and a bone marrow biopsy. Subjects will spend approximately 4 hours at the Hillman Cancer Center or the UPMC Cancer Center location where they are being treated for this re-staging.

  • Post-Treatment Follow UpOther

    After subjects stop receiving the study drugs, they will be followed every 3 months for the first two years, every 6 months for years 2-5, and annually thereafter. The following procedures, which are considered routine for their cancer care, will be done as part of this follow-up:

    • Physical exam
    • Performance status (check of ability to perform daily functions)
    • Recording of any new symptoms and any new medications being taken
    • Blood tests to check blood counts (numbers of red and white blood cells and platelets), blood chemistry (to check organ function), and indicators of disease (immunoglobulins)
    • Urine test (24hr urine)
    • Women who are able to have children will have a pregnancy test (4 weeks after their last dose of lenalidomide).
    • A check of the status of disease (includes bone marrow biopsy, skeletal survey, and blood and urine tests). Bone marrow biopsy will be done at the end of treatment, if subjects have a complete response, and their disease gets worse.
Study groups in NCT01042704
Study groupRoleWhat they receive
Bendamustine, Lenalidomide and DexamethasoneExperimentalTreatment with Bendamustine in combination with Lenalidomide and Dexamethasone will be administered on an outpatient basis. Each treatment cycle will be 28 days dosed according to the Dose Escalation Schema.
Receives: Drug: Bendamustine; Drug: Lenalidomide; Drug: Dexamethasone; Drug: Aspirin; Drug: Prophylaxis; Drug: Antibiotic; Other: Biweekly Follow Up; Other: Cyclical Follow Up; Other: Restaging; Other: Post-Treatment Follow Up

What is being measured

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

  1. To establish the dose of each drug recommended for a future Phase II protocol with the combination

    Measured: 1 year

Secondary outcomes (2)

  1. To explore anti-tumor activity of the combination of Bendamustine plus Lenalidomide and dexamethasone

    Measured: 2.5 years

  2. Toxicity, time to progression, overall survival.

    Measured: 2.5 years

Timeline

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

  1. First posted5 Jan 2010 (estimated)
  2. Study startFeb 2008
  3. Primary completionJan 2011
  4. Study completionMar 2015

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 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
29 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01042704
Sponsor's protocol ID
07-089
Status last verified
Jul 2017
First submitted
4 Jan 2010
Last updated
31 Jul 2017
Results posted
No
Data monitoring committee
Yes

Publications

  • Attal M, Harousseau JL, Stoppa AM, Sotto JJ, Fuzibet JG, Rossi JF, Casassus P, Maisonneuve H, Facon T, Ifrah N, Payen C, Bataille R. A prospective, randomized trial of autologous bone marrow transplantation and chemotherapy in multiple myeloma. Intergroupe Francais du Myelome. N Engl J Med. 1996 Jul 11;335(2):91-7. doi: 10.1056/NEJM199607113350204.

    PubMed 8649495

  • Londono F. Thalidomide in the treatment of actinic prurigo. Int J Dermatol. 1973 Sep-Oct;12(5):326-8. doi: 10.1111/j.1365-4362.1973.tb00066.x. No abstract available.

    PubMed 4747626

  • Vogelsang GB, Farmer ER, Hess AD, Altamonte V, Beschorner WE, Jabs DA, Corio RL, Levin LS, Colvin OM, Wingard JR, et al. Thalidomide for the treatment of chronic graft-versus-host disease. N Engl J Med. 1992 Apr 16;326(16):1055-8. doi: 10.1056/NEJM199204163261604.

    PubMed 1549151

  • Hayashi T, Hideshima T, Akiyama M, Podar K, Yasui H, Raje N, Kumar S, Chauhan D, Treon SP, Richardson P, Anderson KC. Molecular mechanisms whereby immunomodulatory drugs activate natural killer cells: clinical application. Br J Haematol. 2005 Jan;128(2):192-203. doi: 10.1111/j.1365-2141.2004.05286.x.

    PubMed 15638853

  • Strasser K, Ludwig H. Thalidomide treatment in multiple myeloma. Blood Rev. 2002 Dec;16(4):207-15. doi: 10.1016/s0268-960x(02)00031-0.

    PubMed 12350364

  • Tohnya TM, Figg WD. Immunomodulation of multiple myeloma. Cancer Biol Ther. 2004 Nov;3(11):1060-1. doi: 10.4161/cbt.3.11.1303. Epub 2004 Nov 12.

    PubMed 15640623

  • Lentzsch S, LeBlanc R, Podar K, Davies F, Lin B, Hideshima T, Catley L, Stirling DI, Anderson KC. Immunomodulatory analogs of thalidomide inhibit growth of Hs Sultan cells and angiogenesis in vivo. Leukemia. 2003 Jan;17(1):41-4. doi: 10.1038/sj.leu.2402745.

    PubMed 12529658

  • Singhal S, Mehta J, Desikan R, Ayers D, Roberson P, Eddlemon P, Munshi N, Anaissie E, Wilson C, Dhodapkar M, Zeddis J, Barlogie B. Antitumor activity of thalidomide in refractory multiple myeloma. N Engl J Med. 1999 Nov 18;341(21):1565-71. doi: 10.1056/NEJM199911183412102.

    PubMed 10564685

  • Anagnostopoulos A, Weber D, Rankin K, Delasalle K, Alexanian R. Thalidomide and dexamethasone for resistant multiple myeloma. Br J Haematol. 2003 Jun;121(5):768-71. doi: 10.1046/j.1365-2141.2003.04345.x.

    PubMed 12780791

  • Podar K, Anderson KC. The pathophysiologic role of VEGF in hematologic malignancies: therapeutic implications. Blood. 2005 Feb 15;105(4):1383-95. doi: 10.1182/blood-2004-07-2909. Epub 2004 Oct 7.

    PubMed 15471951

  • Palumbo A, Bertola A, Musto P, Caravita T, Callea V, Nunzi M, Grasso M, Falco P, Cangialosi C, Boccadoro M. Oral melphalan, prednisone, and thalidomide for newly diagnosed patients with myeloma. Cancer. 2005 Oct 1;104(7):1428-33. doi: 10.1002/cncr.21342.

    PubMed 16116606

  • Richardson PG, Schlossman RL, Weller E, Hideshima T, Mitsiades C, Davies F, LeBlanc R, Catley LP, Doss D, Kelly K, McKenney M, Mechlowicz J, Freeman A, Deocampo R, Rich R, Ryoo JJ, Chauhan D, Balinski K, Zeldis J, Anderson KC. Immunomodulatory drug CC-5013 overcomes drug resistance and is well tolerated in patients with relapsed multiple myeloma. Blood. 2002 Nov 1;100(9):3063-7. doi: 10.1182/blood-2002-03-0996.

    PubMed 12384400

  • Zangari M, Tricot G, Zeldis J, Eddlemon P, Saghafifar F, Barlogie B. Results of phase I study of CC-5013 for the treatment of multiple myeloma (MM) patients who relapse after high dose chemotherapy (HDCT). Blood. 2001 :775a (A3226).

  • Richardson P, Jagannath 5, Schlossman R, eta!. A multi-center, randomized, phase 2 study to evaluate the efficacy and safety of 2 CC-5013 dose regimens when used alone or in combination with dexamethasone (Dex) for the treatment of relapsed or refractory multiple myeloma (MM). Blood. 2003;1 02:235a.

  • Davies FE, Raje N, Hideshima T, Lentzsch S, Young G, Tai YT, Lin B, Podar K, Gupta D, Chauhan D, Treon SP, Richardson PG, Schlossman RL, Morgan GJ, Muller GW, Stirling DI, Anderson KC. Thalidomide and immunomodulatory derivatives augment natural killer cell cytotoxicity in multiple myeloma. Blood. 2001 Jul 1;98(1):210-6. doi: 10.1182/blood.v98.1.210.

    PubMed 11418482

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Bendamustine, Lenalidomide and Dexamethasone in people with Myeloma, run by Robert Redner, MD at 22 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 19 inclusion and 14 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 31 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 22 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

To establish the dose of each drug recommended for a future Phase II protocol with the combination (time frame: 1 year). 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 NCT01042704, which also lists 27 linked publications.

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 31 Jul 2017; AzTrials last refreshed its copy on 1 Nov 2026.

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