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Multiple MyelomaPhase 1NCT01711671

A Study of DKN-01 and Lenalidomide/Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma

A Phase 1 study testing DKN-01 300 mg and DKN-01 600 mg in people with Multiple Myeloma, run by Leap Therapeutics, Inc. at 3 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

A study to evaluate the safety, efficacy and bone changes with combination therapy of intravenous (IV) infused DKN-01 and lenalidomide/dexamethasone, versus lenalidomide and dexamethasone in relapsed or refractory multiple myeloma (MM) patients Read more about this study

Who is it for?
Ages 30 years and older
Conditions the study is for
Multiple Myeloma
What is being tested?
DKN-01 300 mg and DKN-01 600 mg
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
8 participants
Where
3 sitesUnited States
Study dates
May 2013to Jul 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 30 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Relapsed or refractory Multiple Myeloma (MM)
  • Treated with at least 1 prior regimen for myeloma
  • Prior treatment with bortezomib (Velcade) is acceptable with a wash-out of 2 weeks
  • Treatment with prior autologous transplant is permitted
  • If a transplant is used as consolidation following chemotherapy, without intervening disease progression, it will be considered 1 line of treatment with the preceding chemotherapy
  • Diagnosis of symptomatic MM as defined by the International Myeloma Working Group (IMWG) :
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  • Second line or greater/Refractory/Relapsed, Stage I, Stage II, Stage III
  • Measureable disease as indicated by monoclonal protein in the serum of greater than or equal to (≥) 1 grams per deciliter (g/dL), involved serum free light chain assay ≥10 mg/dL (≥100 mg/L) provided the serum free light chain ratio is abnormal; monoclonal light chain in the urine protein electrophoresis of ≥ 200 mg/24 hours, or measurable plasmacytoma
  • At least 1 osteolytic bone lesion
  • Disease-free of active second/secondary or prior malignancies for equal to or over 5 years with the exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma "in-situ" of the cervix or breast
  • Ambulatory patients greater than or equal to (≥) 30 years of age
  • Performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale
  • Estimated life expectancy of ≥ 26 weeks
  • Adequate organ function including:
  • Hematologic:
  • Absolute neutrophil count (ANC) greater than or equal to (≥) 1000/microliter
  • Platelet (PLT) count ≥ 75,000/microliter
  • Hemoglobin (Hgb) ≥ 8.0 g/dL
  • Acceptable coagulation status:
  • Prothrombin time (PT) and partial thromboplastin time (PTT) ≤ 1.2 x the upper limit of normal (ULN) unless receiving anticoagulation therapy. If receiving anticoagulation therapy, eligibility will be based upon International Normalization Ratio (INR)
  • International normalized ratio (INR) less than or equal to (≤) 1.6 (unless receiving anticoagulation therapy)
  • If receiving warfarin: INR ≤ 3.0 (and no active bleeding, [i.e., no bleeding within 14 days prior to first dose of study therapy])
  • Hepatic:
  • Bilirubin ≤ 1.5 x ULN
  • Alanine Transaminase (ALT) and Aspartate Transaminase (AST) ≤ 2.5 x ULN (if liver metastases are present, then ≤ 5 x ULN is allowed)
  • Renal:
  • Calculated creatinine clearance ≥ 45 mL using the Cockcroft and Gault Method
  • Women of childbearing potential (WCBP) must have a negative serum or urine pregnancy test within 10 to 14 days and again within 24 hours of starting study drug
  • WCBP must agree to have pregnancy tests monthly (every 14 days for women with irregular cycles) while on study drug and 4 weeks after the last dose of study drug
  • Men must also agree to use a condom if their partner is of child bearing potential, even if they have had a successful vasectomy
  • Males and females with reproductive potential must agree to use medically approved contraceptive precautions starting 4 weeks prior to initiation of the therapy and during the trial and for 18 months following the last dose of study drug
  • Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
  • Provide written informed consent prior to any study-specific procedures
  • Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures

Who cannot join

  • Received treatment with an investigational drug, which has not received regulatory approval for any indication, within 28 days of study treatment with DKN-01
  • Received any experimental non-drug therapy (e.g., donor leukocyte/mononuclear cell infusions) within 56 days of entry
  • Previously treated with an anti-Dickkopf-1 (anti-DKK-1) or antibody therapy, or have had a significant allergy to a known pharmaceutical therapy that, in the opinion of the Investigator, poses an increased risk to the patient
  • Received radiation therapy, surgery, or chemotherapy within 2 weeks prior to study entry (6 weeks for nitrosoureas or Mitomycin C)
  • Received bisphosphonates (e.g., etidronate, clodronate, tiludronate, pamidronate, neridronate, olpadronate, alendronate, ibandronate, risedronate, zoledronate) within 2 weeks prior to study entry
  • Symptomatic central nervous system (CNS) malignancy or metastasis. Patients with treated CNS metastases are eligible provided their disease is radiographically stable, asymptomatic, and they are not currently receiving corticosteroids and/or anticonvulsants. Screening of asymptomatic patients without a history of CNS metastases is not required
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  • Have a history of major organ transplant (for example: heart, lungs, liver, and kidney)
  • Are pregnant or nursing
  • Known to be human immunodeficiency virus (HIV) positive, have hepatitis B surface antigen (HBSAg), or hepatitis C antibodies (HCAb)
  • Active, uncontrolled bacterial, viral, or fungal infections, including urinary tract infection, within 7 days of study entry requiring systemic therapy
  • Serious cardiac condition such as myocardial infarction within the past 6 months, unstable angina, or Class III or IV congestive heart failure as defined by the New York Heart Association (NYHA); have ECG abnormalities including baseline 12-lead ECG with Fridericia-corrected QT interval (QTcF) > 470 msec (female) or > 450 msec (male), a history of congenital long QT syndrome, or any ECG abnormality that, in the opinion of the Investigator, would preclude safe participation in the study
  • History of osteonecrosis of the hip or have evidence of structural bone abnormalities in the proximal femur on MRI scan that are considered clinically significant or may have an impact on the interpretation of the scan. Degenerative changes of the hip joint are not exclusionary
  • Known concomitant disease(s) known to influence calcium metabolism including hyperparathyroidism, hyperthyroidism, Paget's disease of bone, or any other concurrent severe or uncontrolled concomitant medical condition that, in the opinion of the Investigator, would preclude participation in this study
  • Patients who are currently receiving lithium chloride (LiCl)

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Emory University Hospital

    Atlanta, Georgia, 30322

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02115

Other trials in United States

About this study

Official title: A Pilot Study of DKN-01 and Lenalidomide (Revlimid®)/Dexamethasone Versus Lenalidomide/Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma

A study to evaluate the safety, efficacy and bone changes with combination therapy of intravenous (IV) infused DKN-01 and lenalidomide/dexamethasone, versus lenalidomide and dexamethasone in relapsed or refractory multiple myeloma (MM) patients

Being tested
DKN-01 300 mg, DKN-01 600 mg, Standard of Care
Medical subject headings
Multiple Myeloma

What participants receive

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

  • DKN-01 300 mgDrug

    300 mg IV infusion of DKN-01 administered twice per 28 day cycle on Days 1 and 15, plus lenalidomide/dexamethasone

  • DKN-01 600 mgDrug

    600 mg IV infusion of DKN-01 administered twice per 28 day cycle on Days 1 and 15, plus lenalidomide/dexamethasone

  • Standard of CareDrug

    Also called Lenalidomide, Revlimid, Dexamethasone

    Current approved standard of care

Study groups in NCT01711671
Study groupRoleWhat they receive
DKN-01 300mgExperimentalDKN-01 plus lenalidomide (Revlimid)/dexamethasone
Receives: Drug: DKN-01 300 mg
DKN-01 600mgExperimentalDKN-01 plus lenalidomide (Revlimid)/dexamethasone
Receives: Drug: DKN-01 600 mg
Standard of CareActive comparatorLenalidomide (Revlimid)/dexamethasone
Receives: Drug: Standard of Care

What is being measured

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

  1. Fluorine F18 sodium fluoride positron emission tomography (NaF-PET/CT) standard uptake value (SUV)

    SUV as measured by NaF-PET/CT in both myeloma bone lesions and normal bone

    Measured: Pre-study to after 6 months of therapy

  2. Fluorine F18 sodium fluoride positron emission tomography (NaF-PET/CT) influx constant (Ki)

    Ki as measured by NaF-PET/CT in both myeloma bone lesions and normal bone

    Measured: Pre-study to after 6 months of therapy

  3. F18 fluorodeoxyglucose positron emission tomography (FDG-PET/CT) standard uptake value (SUV)

    SUV as measured by FDG-PET/CT in both myeloma bone lesions and normal bone

    Measured: Pre-study to after 6 months of therapy

  4. Number of patients with treatment emergent adverse events

    Measured: Baseline to study completion (approximately 7 months)

Secondary outcomes (7)

  1. Overall response rate (ORR)

    Measured: Baseline to study completion (approximately 7 months)

  2. Progression free survival (PFS)

    Measured: Baseline to study completion (approximately 7 months)

  3. Duration of response

    Measured: Baseline to study completion (approximately 7 months)

  4. Overall survival

    Measured: Baseline to study completion (approximately 7 months)

  5. Pharmacokinetics: area under the concentration - time curve (AUC) of a single dose of DKN-01

    Measured: Dosing interval of 2 weeks following the first dose in Cycle 1

  6. Pharmacokinetics: maximum plasma concentration (Cmax) of a single dose of DKN-01

    Measured: Dosing interval of 2 weeks following the first dose in Cycle 1

  7. Pharmacokinetics: trough DKN-01 concentrations on Cycle 2 and Cycle 3

    Measured: Cycle 2 Day 1 Pre-dose, Cycle 3 Day 1 Pre-dose

Timeline

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

  1. First posted22 Oct 2012 (estimated)
  2. Study startMay 2013
  3. Primary completionJul 2015
  4. Study completionJul 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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01711671
Sponsor's protocol ID
DEK-DKK1-P101
Other IDs
DKN-01, LY2812176
Status last verified
Jul 2025
First submitted
18 Oct 2012
Last updated
3 Aug 2025
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing DKN-01 300 mg and DKN-01 600 mg in people with Multiple Myeloma, run by Leap Therapeutics, Inc. at 3 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 34 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 3 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 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?

Fluorine F18 sodium fluoride positron emission tomography (NaF-PET/CT) standard uptake value (SUV) (time frame: Pre-study to after 6 months of therapy). The study lists 4 primary outcomes in all. 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 NCT01711671.

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 3 Aug 2025.

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