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Multiple MyelomaPhase 2NCT04302324

A Phase II Study of Daratumumab, Clarithromycin, Pomalidomide And Dexamethasone (D-ClaPd) In Multiple Myeloma Patients Previously Exposed to Daratumumab

A Phase 2 study testing Daratumumab SC, Clarithromycin and Pomalidomide in people with Multiple Myeloma and Refractory Multiple Myeloma, run by Weill Medical College of Cornell University at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This is a single-center, non-randomized, phase 2 study in which patients will receive daratumumab (subcutaneous, SC) in combination with clarithromycin/pomalidomide/dexamethasone (D-ClaPd) until progressive disease (PD) or unacceptable toxicity. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Daratumumab SC, Clarithromycin and Pomalidomide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
11 participants
Where
1 siteUnited States
Study dates
28 Oct 2021to 28 Dec 2027
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically confirmed Multiple Myeloma
  • Relapsed and/or refractory myeloma defined as follows: Relapse or progressive disease after at least one previous line of therapy which must include prior daratumumab. At least 8 doses of daratumumab in a previous line must be administered either as monotherapy or in combination with a daratumumab-free interval of ≥3 months AND patient may be daratumumab refractory defined as less than a partial remission (PR) achieved on prior daratumumab-based therapy or have exhibited progression within 60 days of receiving daratumumab. If previous therapy was autologous stem cell transplant (SCT), over 3 months must have elapsed after SCT.
  • Measurable disease as defined by > 0.5 g/dL serum monoclonal protein, >0.1 g/dL serum free light chains, >0.2 g/24 hrs urinary M-protein excretion, and/or measurable plasmacytoma(s).
  • Females of childbearing potential(FCBP) must have a negative serum or urine pregnancy test within 10 - 14 days prior to and again within 24 hours of prescribing pomalidomide and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 4 weeks before she starts taking pomalidomide. FCBP must also agree to ongoing pregnancy testing.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
  • Able to take aspirin daily
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  • Life expectancy must be greater than 3 months.
  • Be able to voluntarily sign and understand written informed consent.
  • Absolute neutrophil count (ANC) ≥750 cells/mm3 (.75 x 109/L)
  • Platelets count ≥ 50,000/mm3 (50 x 109/L)
  • Serum SGOT/AST ≤ 2.0 x upper limits of normal
  • Serum SGPT/ALT <3.0 x upper limits of normal
  • Serum creatinine ≤ 2.5 x upper limits of normal
  • Serum total bilirubin ≤ 1.5 x upper limits of normal (Total bilirubin ≥ 1.5 x ULN is acceptable if bilirubin is fractionated and direct bilirubin <35%)
  • All participants must be registered into the mandatory POMALYST REMS™ program and be willing and able to comply with the requirements of the POMALYST REMS™ program.

Who cannot join

  • Prior exposure to non-daratumumab anti-CD38 monoclonal antibodies or pomalidomide. Prior pomalidomide exposure in 1 or more previous lines of therapy allowed if partial remission (PR) or better achieved. No disease progression may have occurred within 60 days of receiving pomalidomide.
  • New York Heart Association (NYHA) Class III or IV heart failure, unstable cardiac arrhythmia, or unstable angina
  • Myocardial infarction within the past 6 months
  • Severe obstructive airway disease
  • Planned high-dose chemotherapy and autologous stem cell transplantation within 6, 28-day treatment cycles after starting on treatment
  • Female patients who are lactating or have a positive serum pregnancy test during the screening period
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  • Failure to have fully recovered (ie, ≤ Grade 1 toxicity) from the reversible effects of prior chemotherapy
  • Major surgery within 14 days before enrollment
  • Radiotherapy within 14 days before enrollment (if area involved is small than within 7 days)
  • Systemic treatment, within 14 days before the first dose, with strong CYP3A inducers (rifampin, rifapentine, rifabutin, carbamazepine, phenytoin, phenobarbital), or use of Ginkgo biloba or St. John's wort
  • Seropositive for human immunodeficiency virus (HIV), hepatitis B, and hepatitis C
  • Any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to this protocol
  • Known allergy to any of the study medications, their analogues, or excipients in the various formulations of any agent
  • Diagnosed or treated for another malignancy within 2 years before study enrollment or previously diagnosed with another malignancy and have any evidence of residual disease. Patients with nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection
  • Patient has greater than Grade 3 peripheral neuropathy, or Grade 2 pain
  • Participation in other clinical trials within 30 days
  • History of thromboembolic event within the past 6 months prior to enrollment

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Weill Cornell Medicine - Multiple Myeloma Center

    New York, New York, 10065

Other trials in United States

About this study

This is a single-center, non-randomized, phase 2 study in which patients will receive daratumumab (subcutaneous, SC) in combination with clarithromycin/pomalidomide/dexamethasone (D-ClaPd) until progressive disease (PD) or unacceptable toxicity. This study will test the hypothesis that in patients with previous daratumumab exposure, combination therapy of clarithromycin/pomalidomide/dexamethasone with daratumumab SC (D-ClaPd) will yield higher Very Good Partial Response (VGPR) rates in relapsed/refractory multiple myeloma patients than historical pomalidomide/dexamethasone treatment.

Being tested
Daratumumab SC, Clarithromycin, Pomalidomide, Dexamethasone
Medical subject headings
Multiple Myeloma

What participants receive

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

  • Daratumumab SCDrug

    Also called Faspro

    Given as 1800mg via injection

  • ClarithromycinDrug

    Given as 500mg oral capsule

  • PomalidomideDrug

    Given as 4mg oral capsule

  • DexamethasoneDrug

    Given as 20mg IV and 20mg or 40mg oral tablets

Study groups in NCT04302324
Study groupRoleWhat they receive
daratumumab/clarithromycin/pomalidomide/dexamethasoneExperimentalInduction Phase: 8 cycles (cycle length of 28 days) * Daratumumab SC: 1800mg SC weekly for 8 weeks for Cycle 1 and 2 1800mg SC every 2 weeks on Day 1 and 15 for Cycle 3-6 1800mg SC every 4 weeks on Day 1 for Cycle 7-8 * Clarithromycin 500mg PO BID until VGPR or 8 cycles, whichever occurs first * Pomalidomide 4mg PO on Days 1-21 * Dexamethasone 20mg IV as pre-medication on Day 1, 8 40mg PO on the day after daratumumab for Cycle 1 Days 15 and 22 40mg PO pre-daratumumab weekly for Cycle 2-6 20mg PO pre-daratumumab weekly for Cycle 7-8 Maintenance Phase (Cycle 9+): Up to 24 cycles (cycle length of 28 days) * Daratumumab 1800 mg SC on Day 1 * Pomalidomide 4mg PO on Day 1-21 * Dexamethasone 20mg PO pre-daratumumab weekly for Cycles 9 and beyond
Receives: Drug: Daratumumab SC; Drug: Clarithromycin; Drug: Pomalidomide; Drug: Dexamethasone

What is being measured

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

  1. Very Good Partial Response Rate or Better Within 8 Cycles of Induction Therapy

    Very Good Partial Response or better defined as the number of participants with a documented Very Good Partial Response (VGPR) or better as best response per International Myeloma Working Group (IMWG) criteria, measured from date of enrollment through the end of the 8th induction cycle.

    Measured: up to end of 8th induction cycle (up to approximately 224 days)

Secondary outcomes (11)

  1. Progression-Free Survival

    Progression-Free Survival (PFS) is measured in months from the date of enrollment to the date of disease progression and/or death. Median estimate is calculated using the Kaplan-Meier methodology.

    Measured: Approximately 3 years

  2. Complete Response Rate or Better

    The number of participants with a documented Complete Response (CR) or better, per International Myeloma Working Group (IMWG) criteria.

    Measured: Approximately 1 year

  3. Time to Progression

    Measured in months between the date of enrollment and the first efficacy evaluation at which the participant has met the criteria for Progressive Disease

    Measured: Approximately 3 years

  4. Time to Next Therapy

    Measured in months from the date of enrollment to the start date of subsequent treatment for relapsed/refractory multiple myeloma

    Measured: Approximately 3 years

  5. Duration of Response

    Duration of Response (DoR) is defined as the time between the date of initial documentation of best response to the date of first documented evidence of disease progression.

    Measured: Approximately 3 years

  6. Rate of Minimal Residual Disease (MRD) Negativity

    Defined as a number of MRD negative participants

    Measured: Approximately 8 months

  7. Rate of Improvement in Response During Maintenance Therapy

    Percentage of patients that achieved an improved response during maintenance compared to end of induction.

    Measured: Approximately 3 years

  8. Time to Best Response

    Measured in months between the date of enrollment and the first efficacy evaluation at which the participant has met criteria for best response per International Myeloma Working Group (IMWG) criteria.

    Measured: Approximately 9.5 months

  9. Overall Response Rate

    The number of participants with a documented Overall Response (Partial Response or better), per International Myeloma Working Group (IMWG) criteria.

    Measured: Approximately 1 year

  10. Very Good Partial Response (VGPR) Rate or Better

    The number of participants with a documented Very Good Partial Response (VGPR) Rate or better, per International Myeloma Working Group (IMWG) criteria.

    Measured: Approximately 1 year

  11. Overall Survival

    Overall Survival (OS) is measured in months from the date of enrollment to the date of the participant's death. Greenwood's formula will be used to calculate 95% confidence intervals for the Kaplan-Meier survival estimates.

    Measured: Approximately 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 posted10 Mar 2020
  2. Study start28 Oct 2021
  3. Primary completion31 May 2024
  4. Study completion28 Dec 2027 (estimated)

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
11 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04302324
Sponsor's protocol ID
19-12021155
Status last verified
May 2026
First submitted
6 Mar 2020
Last updated
20 May 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Daratumumab SC, Clarithromycin and Pomalidomide in people with Multiple Myeloma and Refractory Multiple Myeloma, run by Weill Medical College of Cornell University at 1 site 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 15 inclusion and 17 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: under way, not looking for participants, as of the sponsor's last update on 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Very Good Partial Response Rate or Better Within 8 Cycles of Induction Therapy (time frame: up to end of 8th induction cycle (up to approximately 224 days)). 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 NCT04302324.

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 20 May 2026.

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