CClinicalTrials.gg
Sign In
CompletedNCT02441686Updated Jan 13, 2026Results posted

Phase II Study of Efficacy and Safety of Lenalidomide, Subcutaneous Bortezomib and Dexamethasone Therapy for Newly Diagnosed Multiple Myeloma

A Phase 2 interventional study of Bortezomib and Lenalidomide in Multiple Myeloma, sponsored by Dana-Farber Cancer Institute. Completed at 8 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-13.

Sponsored by Dana-Farber Cancer Institute · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
46
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

This research study is evaluating a combination of three drugs called lenalidomide, subcutaneous (injection under the skin) bortezomib, and dexamethasone (RVD) as a possible treatment for multiple myeloma.

Read the detailed description

This research study is a Phase II clinical trial, which tests the safety and effectiveness of an investigational combination of drugs to learn whether the combination of drugs works in treating a specific cancer. "Investigational" means that the combination of drugs is being studied. It also means that the FDA (the U.S. Food and Drug Administration) has not yet approved the combination of drugs for your type of cancer.

Each of the individual drugs, lenalidomide , subcutaneous bortezomib, and dexamethasone, are approved by the U.S. Food and Drug Administration (FDA). The combination has not been approved yet for multiple myeloma or any other type of cancer. Subcutaneous bortezomib is currently approved by the U.S. FDA for the treatment of patients with relapsed/refractory multiple myeloma. Lenalidomide is currently approved for use with dexamethasone for patients with multiple myeloma who have received at least one prior therapy and for the treatment of certain types of myelodysplastic syndrome (another form of cancer affecting the blood). Both Bortezomib and Lenalidomide kill tumor cells and help the body cells to fight cancer. Dexamethasone is commonly used, either alone, or in combination with other drugs, to treat multiple myeloma. Dexamethasone heps to reduce irritation and cell injury (inflammation).

In this research study, the investigators are looking to explore the drug combination of lenalidomide, subcutaneous bortezomib and dexamethasone to see what side effects it may have and how well it works for treatment of newly diagnosed multiple myeloma. This 3 drug regimen showed promising results in previous studies, however administration of intravenous bortezomib caused high levels of nerve injury (a condition involving the nerves of the upper and lower extremities associated with numbness, tingling and burning). In this study, the investigators are testing the hypothesis that subcutaneous administration of bortezomib will result in less nerve toxicity. Therefore, the combination of lenalidomide, dexamethasone and subcutaneous bortezomib may be better tolerated and may allow for a longer duration of therapy.

02

Conditions studied

  • Multiple Myeloma

Browse trials for

Keywords

  • Multiple Myeloma
03

In context

Multiple Myeloma

3,632 studies on the registry are indexed under Multiple Myeloma; 745 are open to participants now.

This study's enrollment of 46 is above the median of 41 across 2,907 interventional studies indexed under Multiple Myeloma.

Browse Multiple Myeloma studies →

Lead sponsor

Dana-Farber Cancer Institute is the lead sponsor of 813 studies on the registry; 124 are open to participants now.

Of its 113 completed or terminated interventional studies of FDA-regulated products, 77 (68%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Diagnosis of symptomatic MM, according to International Myeloma Foundation 2003 Diagnostic Criteria:

    • Clonal plasma cells >10% on bone marrow biopsy
    • A monoclonal protein (paraprotein) in either serum or urine(except in cases of non-secretory myeloma)*

    • Myeloma-related organ dysfunction (1 or more) of the following (evidence of end-organ damage felt related to the plasma cell disorder related organ or tissue impairment (ROTI), commonly referred to by the acronym "CRAB"):

      • Serum Ca ≥ 10.5 mg/dL or
      • Renal insufficiency attributable to myeloma. Serum creatinine > 2mg/dL
      • Anemia: Normochromic, normocytic with a hemoglobin value > 2g/dL below the lower limit of normal or a hemoglobin \<10 g/dL
      • Bone lesions (lytic lesions, severe osteopenia or pathologic fractures) or osteoporosis. *If no monoclonal protein is detected (non-secretory disease), then >/= 30% monoclonal bone marrow plasma cells and/or a biopsy-proven plasmacytoma required.

  • Has received no prior treatment with any systemic therapy for the treatment of multiple myeloma

    • Prior treatment of hypercalcemia or spinal cord compression with corticosteroids does not disqualify the patient (the dose should not exceed the equivalent of 160 mg of dexamethasone in a 2 week period).
    • Bisphosphonates are permitted.
    • Local radiation as long as two weeks have lapsed since last date of radiotherapy, which is recommended to be a limited field.
  • Age ≥18 years at the time of signing Informed Consent
  • ECOG performance status ≤ 2 (Karnofsky ≥ 50%)
  • Voluntary written informed consent

  • Subject must be able to adhere to the study visit schedule and other protocol requirements.

    • Females of reproductive potential must adhere to the scheduled pregnancy testing as required in the Revlimid REMS® program. Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 50 µL/mL 10 to14 days prior to therapy and repeated again within 24 hours prior to prescribing lenalidomide for Cycle 1 and must either commit to complete abstinence from heterosexual contact or begin TWO acceptable methods of birth control, one highly effective method and one additional effective (barrier) method, AT THE SAME TIME, at least 28 days before she starts taking lenalidomide. FCBP must also agree to ongoing pregnancy testing. Men must practice complete abstinence or agree to use a condom during sexual contact with a FCBP even if they have had a successful vasectomy. All study participants must be registered into the mandatory Revlimid REMS® program, and be willing and able to comply with the requirements of the REMS® program- Ability to understand and the willingness to sign a written informed consent document

Exclusion criteria

Exclusion Criteria:

  • Participants who exhibit any of the following conditions at screening will not be eligible for admission into the study.
  • Renal insufficiency (serum creatinine levels > 2.5 mg/dL, calculated Crcl with Cockcroft-Gault formula, see Appendix B, \< 45 ml/min)
  • Subjects with evidence of mucosal or internal bleeding and/or platelet refractory (i.e., unable to maintain a platelet count ≥ 50,000 cells/mm3)
  • Subjects with an absolute neutrophil count (ANC) \< 1000 cells/mm3. Growth factors may not be used to meet ANC eligibility criteria
  • Subjects with a hemoglobin \< 8.0 g/dL
  • AST (SGOT) and ALT (SGPT) > 2 x institutional ULN, bilirubin levels ≥1.5 institutional ULN
  • Concomitant therapy medications that include corticosteroids (except as indicated in inclusion criteria).
  • Myocardial infarction within 6 months prior to enrollment or has New York Heart Association (NYHA) Class III or IV heart failure (Appendix C), uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities.
  • Clinically relevant active infection requiring treatment (antibiotics, antivirals, antifungals).
  • Any serious co-morbid condition, including laboratory abnormalities, that in the opinion of the Investigator places the subject at unacceptable risk if he/she were to participate in the study.
  • Female subject is pregnant or breast-feeding.
  • Serious psychiatric illness or addiction likely to interfere with participation in this clinical study.
  • Uncontrolled diabetes mellitus.
  • Contraindication to any required concomitant drugs or supportive therapies including hypersensitivity to all anticoagulation and antiplatelet options or hypersensitivity to acyclovir or similar anti-viral drug.
  • History of allergic reaction/hypersensitivity attributed to compounds containing boron, mannitol, polysorbate 80 or sodium citrate dehydrate.
  • POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein (M-protein) and skin changes).

  • Known seropositive for or active HIV infection or hepatitis B or C viral infection.

    • Patients who are seropositive because of hepatitis B virus vaccine are eligible.
  • Known intolerance to steroid therapy.
  • Patient has hypersensitivity to bortezomib, boron, or mannitol.
  • Diagnosed or treated for another malignancy within 2 years of enrollment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy, or low-risk prostate cancer after curative therapy.
  • Participation in clinical trials with other investigational agents not included in this trial, within 14 days of the start of this trial and throughout the duration of this trial.
  • Radiation therapy within 2 weeks of enrollment. Enrollment of subjects who require concurrent radiotherapy (which must be localized in its field size) should be deferred until the radiotherapy is completed and 2 weeks have elapsed since the last date of therapy.
  • Participant must be able to swallow pills.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
46 participants (actual)

Study arms

  • Experimental
    Lenalidomide, subcutaneous Bortezomib, Dexamethasone

    Lenalidomide (R): 25 mg on days 1-14 orally Subcutaneous Bortezomib (sqV): 1.3 mg/m\^2 on days 1, 4, 8 and 11 Dexamethasone (d): 20 mg on days 1, 2, 4, 5, 8, 9, 11 and 12 Stem cell mobilization occurs at the end of Cycle 4. Participants may elect to stop treatment at the end of Induction Cycle 4 and proceed to autologous stem cell transplant (ASCT) with melphalan 200 mg/m\^2 conditioning, or receive a full 8 cycles of RsqVd induction therapy. RsqVd cycle duration is 21-days. Maintenance follows with the specific regimen determined by risk category. High-risk participants defined as those with International Staging System (ISS) stage II or stage III disease and/or high-risk cytogenetics including t(4;14), t(4; 16), del(17p) receive sqV of 1.3 mg/m\^2 on days 1 and 15 in addition to R 10mg (15mg after cycle 3 if tolerated) on days 1-21 of 28-day cycle. Standard-risk participants receive R monotherapy.

    Drug: Bortezomib · Drug: Lenalidomide · Drug: Dexamethasone · Procedure: Stem Cell Mobilization · Procedure: Autologous Stem Cell Transplant

Interventions

  • DrugBortezomib

    Also known as: Velcade®

  • DrugLenalidomide

    Also known as: Revlimid®

  • DrugDexamethasone

    Also known as: Decadron, Dexasone, Diodex, Hexadrol, Maxidex

  • ProcedureStem Cell Mobilization
  • ProcedureAutologous Stem Cell Transplant

    Also known as: ASCT

06

What researchers measure

Primary outcomes

  1. 4-Cycle Induction Overall Response Rate (ORR)

    4-cycle ORR was defined as the percentage of participants who achieved partial response or better based on the International Myeloma Working Group Response (IMWG) criteria during the first 4 cycles of induction therapy.

    Time frame: Participants were followed up to 12 weeks.

  2. Induction Overall Response Rate (ORR)

    Induction ORR was defined as the percentage of participants who achieved partial response or better based on the International Myeloma Working Group Response (IMWG) criteria during induction therapy either 4 cycles or 8 cycles of combination therapy. Response on ASCT is not included.

    Time frame: Participants were followed up to 24 weeks.

  3. Four-cycle Induction Peripheral Neuropathy (PN) Rate

    Four-cycle induction PN rate was defined as the proportion of participants who experienced peripheral neuropathy includes any attribution and any grades based on the Common Toxicity Criteria for Adverse Events Version 4.0 (CTCAEv4) during the first 4 cycles of induction therapy.

    Time frame: Participants were followed up to 12 weeks.

  4. Grade 3-4 Induction Peripheral Neuropathy Rate

    Grade 3-4 induction peripheral neuropathy rate was defined as the proportion of participants who experienced grade 3 or 4 peripheral neuropathy based on the Common Toxicity Criteria for Adverse Events Version 4.0 (CTCAEv4) as reported on case report forms during induction therapy (4 cycles RsqVd for ASCT patients and 8 cycles for non-ASCT patients).

    Time frame: Participants were followed up to 24 weeks.

Secondary outcomes

  1. Median Time to Progression (TTP)

    Median TTP based on KM method is defined as the time from first dose of treatment to the first progression event or censored at date last disease assessment. PD, based on IMWG criteria, requires 1+ of the following: \>25% increase in the level of serum monoclonal paraprotein, which must also be an absolute increase of at least 5 g/L and confirmed on a repeat investigation. \>25% increase in 24h urinary light chain excretion, which must also be an absolute increase of at least 200 mg/24 h and confirmed on a repeat investigation. \>25% increase in plasma cells in a bone marrow aspirate or on trephine biopsy, which must also be an absolute increase of at least 10%. Definite increase in the size of existing lytic bone lesions or soft tissue plasmacytomas. Development of new bone lesions or soft tissue plasmacytomas. Development of hypercalcemia.

    Time frame: Disease was assessed up to 41.2 months.

  2. 1-Year Progression Free Survival (PFS) Probability

    1-year PFS is the probability estimate at 1 year based on the Kaplan-Meier method. PFS is defined as the duration of time from study entry to documented disease progression or death from any cause, censored at the date last known progression-free for those who have not progressed or died. PD, based on IMWG criteria, requires 1+ of the following: \>25% increase in the level of serum monoclonal paraprotein, which must also be an absolute increase of at least 5 g/L and confirmed on a repeat investigation. \>25% increase in 24h urinary light chain excretion, which must also be an absolute increase of at least 200 mg/24 h and confirmed on a repeat investigation. \>25% increase in plasma cells in a bone marrow aspirate or on trephine biopsy, which must also be an absolute increase of at least 10%. Definite increase in the size of existing lytic bone lesions or soft tissue plasmacytomas. Development of new bone lesions or soft tissue plasmacytomas. Development of hypercalcemia.

    Time frame: Median follow up for PFS is 13.4 months with the relevant observation timepoint equal to 1 year.

  3. Median Duration of Response (DOR)

    DOR was defined at the time from the first assessment indicating PR or better response to the first progression (PD) event based on IMWG criteria.

    Time frame: Disease was assessed up to 41.2 months.

  4. 1-year Overall Survival (OS) Rate

    1-year OS rate was defined as the percentage of participants alive at 1 year.

    Time frame: Survival was assessed up to 1 year.

07

Results

Posted Mar 4, 2024

Participant flow

Participants were enrolled from December 2015 to June 2017.

Induction
Participant flow — Induction
MilestoneLenalidomide, Subcutaneous Bortezomib, Dexamethasone
Started46
Safety42
Progression-free survival evaluable41
Evaluable for induction response40
Received autologous stem cell transplant (asct)15
Completed38
Not completed8
Withdrew: Adverse event4
Withdrew: Complicating disease1
Withdrew: Physician decision1
Withdrew: Withdrawal by subject1
Withdrew: Did not receive treatment1
Maintenance
Participant flow — Maintenance
MilestoneLenalidomide, Subcutaneous Bortezomib, Dexamethasone
Started38
Safety35
Completed0
Not completed38
Withdrew: Remaining on treatment23
Withdrew: Physician decision1
Withdrew: Adverse event3
Withdrew: Progressive disease10
Withdrew: Withdrawal by subject1

Outcome measures

Primary4-Cycle Induction Overall Response Rate (ORR)

4-cycle ORR was defined as the percentage of participants who achieved partial response or better based on the International Myeloma Working Group Response (IMWG) criteria during the first 4 cycles of induction therapy.

Time frame:
Participants were followed up to 12 weeks.
Reported as:
Number · percentage of participants
4-Cycle Induction Overall Response Rate (ORR)
percentage of participantsLenalidomide, Subcutaneous Bortezomib, Dexamethasone
4-Cycle Induction Overall Response Rate (ORR)95 (85 to 99)
PrimaryInduction Overall Response Rate (ORR)

Induction ORR was defined as the percentage of participants who achieved partial response or better based on the International Myeloma Working Group Response (IMWG) criteria during induction therapy either 4 cycles or 8 cycles of combination therapy. Response on ASCT is not included.

Time frame:
Participants were followed up to 24 weeks.
Reported as:
Number · percentage of participants
Induction Overall Response Rate (ORR)
percentage of participantsLenalidomide, Subcutaneous Bortezomib, Dexamethasone
Induction Overall Response Rate (ORR)97.5 (89 to 99)
PrimaryFour-cycle Induction Peripheral Neuropathy (PN) Rate

Four-cycle induction PN rate was defined as the proportion of participants who experienced peripheral neuropathy includes any attribution and any grades based on the Common Toxicity Criteria for Adverse Events Version 4.0 (CTCAEv4) during the first 4 cycles of induction therapy.

Time frame:
Participants were followed up to 12 weeks.
Reported as:
Number · proportion of participants
Four-cycle Induction Peripheral Neuropathy (PN) Rate
proportion of participantsLenalidomide, Subcutaneous Bortezomib, Dexamethasone
Four-cycle Induction Peripheral Neuropathy (PN) Rate0.71 (0.58 to 0.83)
PrimaryGrade 3-4 Induction Peripheral Neuropathy Rate

Grade 3-4 induction peripheral neuropathy rate was defined as the proportion of participants who experienced grade 3 or 4 peripheral neuropathy based on the Common Toxicity Criteria for Adverse Events Version 4.0 (CTCAEv4) as reported on case report forms during induction therapy (4 cycles RsqVd for ASCT patients and 8 cycles for non-ASCT patients).

Time frame:
Participants were followed up to 24 weeks.
Reported as:
Number · proportion of participants
Grade 3-4 Induction Peripheral Neuropathy Rate
proportion of participantsLenalidomide, Subcutaneous Bortezomib, Dexamethasone
Grade 3-4 Induction Peripheral Neuropathy Rate0.07 (0.02 to 0.17)
SecondaryMedian Time to Progression (TTP)

Median TTP based on KM method is defined as the time from first dose of treatment to the first progression event or censored at date last disease assessment. PD, based on IMWG criteria, requires 1+ of the following: \>25% increase in the level of serum monoclonal paraprotein, which must also be an absolute increase of at least 5 g/L and confirmed on a repeat investigation. \>25% increase in 24h urinary light chain excretion, which must also be an absolute increase of at least 200 mg/24 h and confirmed on a repeat investigation. \>25% increase in plasma cells in a bone marrow aspirate or on trephine biopsy, which must also be an absolute increase of at least 10%. Definite increase in the size of existing lytic bone lesions or soft tissue plasmacytomas. Development of new bone lesions or soft tissue plasmacytomas. Development of hypercalcemia.

Time frame:
Disease was assessed up to 41.2 months.
Reported as:
Median · Months
Median Time to Progression (TTP)
MonthsLenalidomide, Subcutaneous Bortezomib, Dexamethasone
Median Time to Progression (TTP)NA (29.7 to NA)
Secondary1-Year Progression Free Survival (PFS) Probability

1-year PFS is the probability estimate at 1 year based on the Kaplan-Meier method. PFS is defined as the duration of time from study entry to documented disease progression or death from any cause, censored at the date last known progression-free for those who have not progressed or died. PD, based on IMWG criteria, requires 1+ of the following: \>25% increase in the level of serum monoclonal paraprotein, which must also be an absolute increase of at least 5 g/L and confirmed on a repeat investigation. \>25% increase in 24h urinary light chain excretion, which must also be an absolute increase of at least 200 mg/24 h and confirmed on a repeat investigation. \>25% increase in plasma cells in a bone marrow aspirate or on trephine biopsy, which must also be an absolute increase of at least 10%. Definite increase in the size of existing lytic bone lesions or soft tissue plasmacytomas. Development of new bone lesions or soft tissue plasmacytomas. Development of hypercalcemia.

Time frame:
Median follow up for PFS is 13.4 months with the relevant observation timepoint equal to 1 year.
Reported as:
Number · percentage probability
1-Year Progression Free Survival (PFS) Probability
percentage probabilityLenalidomide, Subcutaneous Bortezomib, Dexamethasone
1-Year Progression Free Survival (PFS) Probability89.2 (79.2 to 99.3)
SecondaryMedian Duration of Response (DOR)

DOR was defined at the time from the first assessment indicating PR or better response to the first progression (PD) event based on IMWG criteria.

Time frame:
Disease was assessed up to 41.2 months.
Reported as:
Median · Months
Median Duration of Response (DOR)
MonthsLenalidomide, Subcutaneous Bortezomib, Dexamethasone
Median Duration of Response (DOR)NA (24.2 to NA)
Secondary1-year Overall Survival (OS) Rate

1-year OS rate was defined as the percentage of participants alive at 1 year.

Time frame:
Survival was assessed up to 1 year.
Reported as:
Number · percentage of participants
1-year Overall Survival (OS) Rate
percentage of participantsLenalidomide, Subcutaneous Bortezomib, Dexamethasone
1-year Overall Survival (OS) Rate100 (93 to 100)

Adverse events

Collected over AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Lenalidomide, Subcutaneous Bortezomib, Dexamethasone - Induction Phase0/42 (0%)8/42 (19%)42/42 (100%)
Lenalidomide, [Subcutaneous Bortezomib] - Maintenance Phase0/35 (0%)8/35 (22.9%)30/35 (85.7%)
Most frequent serious events
Showing 10 of 23
Most frequent serious events
EventLenalidomide, Subcutaneous Bortezomib, Dexamethasone - Induction PhaseLenalidomide, [Subcutaneous Bortezomib] - Maintenance Phase
Neutrophil count decreasedInvestigations0/422/35
Upper respiratory infectionInfections and infestations1/421/35
ColitisGastrointestinal disorders0/421/35
PneumoniaInfections and infestations0/421/35
SinusitisInfections and infestations0/421/35
FallInjury, poisoning and procedural complications0/421/35
Acute kidney injuryRenal and urinary disorders0/421/35
Renal impairmentRenal and urinary disorders0/421/35
Pleural effusionRespiratory, thoracic and mediastinal disorders0/421/35
PneumonitisRespiratory, thoracic and mediastinal disorders0/421/35
Most frequent other events
Showing 10 of 205
Most frequent other events
EventLenalidomide, Subcutaneous Bortezomib, Dexamethasone - Induction PhaseLenalidomide, [Subcutaneous Bortezomib] - Maintenance Phase
Peripheral sensory neuropathyNervous system disorders33/4211/35
FatigueGeneral disorders24/429/35
ConstipationGastrointestinal disorders23/426/35
HypercholesterolaemiaInvestigations23/4211/35
Neutrophil count decreasedInvestigations16/4218/35
Rash maculo-papularSkin and subcutaneous tissue disorders17/423/35
Upper respiratory infectionInfections and infestations16/4214/35
Edema limbsGeneral disorders16/427/35
Pain in extremityMusculoskeletal and connective tissue disorders16/428/35
DiarrheaGastrointestinal disorders11/4212/35

Baseline characteristics

The analysis population is all enrolled participants.

Age, Continuous
Age, Continuous(years)Lenalidomide, Subcutaneous Bortezomib, Dexamethasone
Median61.5 (42 to 78)
Sex: Female, Male
Sex: Female, Male(Participants)Lenalidomide, Subcutaneous Bortezomib, Dexamethasone
Female19
Male27
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Lenalidomide, Subcutaneous Bortezomib, Dexamethasone
Hispanic or Latino2
Not Hispanic or Latino41
Unknown or Not Reported3
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Lenalidomide, Subcutaneous Bortezomib, Dexamethasone
American Indian or Alaska Native0
Asian1
Native Hawaiian or Other Pacific Islander0
Black or African American3
White40
More than one race0
Unknown or Not Reported2
ECOG Performance Score (PS)
ECOG Performance Score (PS)(participants)Lenalidomide, Subcutaneous Bortezomib, Dexamethasone
ECOG PS 019
ECOG PS 121
ECOG PS 22
Unknown4
08

Study locations

8 sites
  • Colorado Blood Cancer Institute
    Denver, Colorado 80218, United States
  • Eastern Maine Medical Center
    Brewer, Maine 04412, United States
  • Massachusetts General Hosptial
    Boston, Massachusetts 02114, United States
  • Beth Israel Deaconess Medical Center
    Boston, Massachusetts 02215, United States
  • Dana Farber Cancer Institute
    Boston, Massachusetts 02215, United States
  • Virginia Piper Cancer Institute
    Coon Rapids, Minnesota 55433, United States
  • Virgina Piper Cancer Institute
    Minneapolis, Minnesota 55407, United States
  • Hematology Oncology of Northern New Jersey
    Morristown, New Jersey 07962, United States
09

References and documents

Publications

  • O'Gorman P, Laubach JP, O'Dwyer ME, Krawczyk J, Yee AJ, Gilligan O, Cahill MR, Rosenblatt J, Quinn J, Murphy PT, DiPietro H, Perera MR, Crotty GM, Cummings K, Hayden PJ, Browne P, Savell A, O'Leary HM, O'Keeffe D, Masone K, Hennessy BJ, Guerrero Garcia T, Scott K, Saeed K, Bianchi G, Dowling P, Tierney C, Richardson PG. Phase 2 studies of lenalidomide, subcutaneous bortezomib, and dexamethasone as induction therapy in patients with newly diagnosed multiple myeloma. Am J Hematol. 2022 May;97(5):562-573. doi: 10.1002/ajh.26491. Epub 2022 Feb 18. PubMed 35132679 ↗

Study documents

  • Protocol and statistical analysis plan · Apr 18, 2022

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 13, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02441686
Lead sponsor
Dana-Farber Cancer Institute
Collaborators
Millennium Pharmaceuticals, Inc., Celgene
Responsible party
Jacob Laubach, MD (Principal Investigator, Dana-Farber Cancer Institute) — Principal investigator
First posted
May 12, 2015
Start date
Dec 2015
Primary completion
Dec 2021
Completion
Oct 2025
Results posted
Mar 4, 2024
Last update
Jan 13, 2026

Study contacts

Jacob Laubach
principal investigator · Dana-Farber Cancer Institute

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Multiple Myeloma→

Other studies from this sponsor

Dana-Farber Cancer Institute

Start the discussion